21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

78 FR 11611 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of... Analysis and Risk-Based Preventive Controls for Human Food.'' FOR FURTHER INFORMATION CONTACT: Domini Bean... Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' with a 120-day comment...

78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of... Hazard Analysis and Risk- Based Preventive Controls for Human Food'' and its information collection... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' IV. How To...

Schistosomiasis knowledge, attitude, practices, and associated factors among primary school children in the Siphofaneni area in the Lowveld of Swaziland.

PubMed

Maseko, Thokozani S B; Mkhonta, Nkosazana R; Masuku, Sakhile K S; Dlamini, Sabelo V; Fan, Chia-Kwung

2018-02-01

Schistosomiasis, a worldwide concern, has received attention in Swaziland through control programs such as deworming programs, education programs, and school health programs; however, these programs neglect the importance of monitoring and evaluation strategies such as assessing children's knowledge, attitudes and practices (KAPs) and the prevalence of the disease. Children are a high-risk group because of their water contact practices, and need to be informed about schistosomiasis to influence their attitudes and practices. Social and cultural factors are involved in schistosomiasis control because they instill myths and misconceptions about the disease. As a result, children in the community may be comfortable with bad practices. This study aimed to assess the KAPs of schoolchildren on schistosomiasis, and to identify practices that support or hinder the progress of schistosomiasis control. In 2014, a descriptive quantitative cross-sectional survey was conducted through questionnaires among Siphofaneni primary schools, an area hit by schistosomiasis in the Lowveld of Swaziland. A logistic regression model was applied to analyze the data. Moderate knowledge, good attitudes, and fairly good practices were observed in the children. However, practices of certain children were risky and they still had some misconceptions. Knowledge was correlated with practice and with predictors of good and bad practices such as male sex, always urinating in water, and always using river water for domestic practices. This study suggests that empowering children with knowledge and attempting to modify their water contact, and improved human waste disposal practices are necessary for schistosomiasis control. Copyright © 2016. Published by Elsevier B.V.

78 FR 76836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements..., or Holding Operations for Dietary Supplements--21 CFR Part 111 (OMB Control Number 0910-0606...

The confusion in complying with good manufacturing practice requirements in Malaysia

NASA Astrophysics Data System (ADS)

Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

2016-11-01

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.

40 CFR 52.2465 - Original identification of plan section.

Code of Federal Regulations, 2011 CFR

2011-07-01

... engineering practice (GEP) stack height,” “hazardous air pollutant,” “nearby,” “stationary source” and... good engineering practice (GEP) stack height requirements submitted on May 12, 1986 by the Virginia... Executive Director, Virginia State Air Pollution Control Board, transmitting the revised good engineering...

Healthcare associated infection: good practices, knowledge and the locus of control in heatlhcare professionals.

PubMed

Taffurelli, Chiara; Sollami, Alfonso; Camera, Carmen; Federa, Francesca; Grandi, Annise; Marino, Marcella; Marrosu, Tiziano; Sarli, Leopoldo

2017-07-18

  The incidence of Healthcare Associated Infections (HAI) is an important indicator of the quality of care. The behaviors associated with the prevention of infections are not only supported by rational knowledge or motivation, but are mediated by social, emotional and often stereotyped behaviors. The awarness of the good practices related to HAI, may be a factor. Other studies, identify how the perception of the problem in healthcare professionals is often influenced by a tendency towards an external Locus of Control: the patient, the family, the other wards, other care settings. The aim of this study is to investigate the perception of healthcare professionals. In particular they have been measured their  awarness of the good practices, perceptions of the potential contamination level of some commonly used objects, knowledge about the management of invasive devices, Locus of Control.   A cross-sectional correlational design was utilized.  An ad hoc questionnaire was interviewed by 222 health professionals nurses and physicians in a northern hospital of Italy. The percentage of professionals who have attended training courses over the last 5 years was quite high, both for upgrades on HAI (78.7%) and Vascular Catheters (78.8%), while the percentage of professionals who updated on bladder catheterization (59.46%) was lower. The mean  score of good practice awareness towards HAI (5.06), is high. The perception of the potential level of contamination of some devices had a  mean ranging from 4.62 (for the drip) to 5.26 (for the door handle). The average value of the Locus of Control (43.54) indicates that participants demonstrated a value that is midway between External and Internal. The correlation test analysis revealed no significant relationships among professionals'age, knowledge about HAI, or infection related venus catheter. Also, results revealed that there were statistically significant positive relationships between professionals' Good Practices awareness about HAI , Knowledge, and Locus of Control. The study findings demonstrated that good practice awareness towards HAI among nurse and physician was good but not completely optimal. Findings revealed that knowledge toward HAI prevention and HAI related device prevention were not completely adequate. The educational courses, according to our correlational findings, should definitely take into account the psycho-social aspects of this phenomenon.

21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

Knowledge and practice of tuberculosis infection control among health professionals in Northwest Ethiopia; 2011.

PubMed

Temesgen, Chanie; Demissie, Meaza

2014-11-19

Tuberculosis (TB) is highly prevalent in sub-Saharan Africa, making the risk of infection transmission high in these countries. Despite high prevalence of TB and expected high probability of nosocomial transmission in Ethiopia, a rapid assessment done in 2008 revealed that most health facilities in Ethiopia do not use tuberculosis infection control (TBIC) practices. Patients and providers are therefore at risk of exposure to TB, especially at high case load facilities. The purpose of this study was to assess TBIC knowledge and practices among health professionals working in hospitals in the Amhara region of Northwest Ethiopia. An institution-based hybrid study was implemented form August 2010 to January 2011. The subjects were health professionals who were proportionally selected from each hospital. Subjects self-administered a questionnaire that contained sections on socio-demographics and on TBIC knowledge and practice. Those answering ≥60% of knowledge questions correctly and ≥50% of practice questions correctly were considered to have good knowledge and practice, respectively. A total of 313 healthcare professionals were enrolled from four healthcare facilities. The response rate was 96%. Only 18.8% received in-service training. Among those who were trained, 74.4%, 95% CI (69.6, 79.3%) were found to have good knowledge and 63.2%, 95% CI (57.9, 68.6%) good practice on TBIC. Training was found to be a predictor of TBIC knowledge, AOR* 3.386 and 95% CI (1.377, 8.330) while knowledge of TBIC was a strong predictor of good TBIC practice, AOR* 10.667 and 95% CI (5.769, 19.721). Though the majority of the respondents had good TBIC knowledge and practice, a considerable proportion of healthcare professionals were not trained on TBIC. Respondents trained on TBIC were found to be more knowledgeable than those not trained. Similarly, respondents with good TBIC knowledge were 10 times more likely to have good TBIC practice compared to those with poor TBIC knowledge. Training was not found to have an effect on TBIC practice. *Adjusted Odds Ratio.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

Control Points in School Business Management, Presenting General Observations, Specific Control Points, and a Series of Checkpoints for the Practicing School Business Administrator.

ERIC Educational Resources Information Center

Association of School Business Officials, Chicago, IL.

This revised outline of a 1962 address contains general guidelines considered still useful for practicing school business administrators. Introductory "general observations" and a preamble give advice about good personal qualities, policy and planning practices, and relations with school boards, community, staff, and fellow professional…

Long-term effects of good handling practices during the pre-weaning period of crossbred dairy heifer calves.

PubMed

Silva, Luciana Pontes; Sant'Anna, Aline Cristina; Silva, Lívia Carolina Magalhães; Paranhos da Costa, Mateus José Rodrigues

2017-01-01

The aim of this study was to determine whether applying good practices of handling during the pre-weaning period have long-term effects on behavioral and physiological indicators, health status, and average daily gain (ADG) of crossbred Bos taurus × Bos indicus heifer calves. During the pre-weaning period, 98 crossbred of Holstein × Gir heifer calves were allotted into three treatments: (1) good practices of handling + brushing (GPB; n = 25), (2) good practices of handling (GP; n = 25), and (3) control (n = 48). Every 2 months, four evaluation periods (EV 1 to EV 4 ) were conducted to record data. Behavioral indicators comprised time to drive (TD), flight speed (FS), flight distance (FD), and composite reactivity score (CRS). Physiological indicators of acute stress during handling comprised respiratory and heart rates. Health status comprised data regarding occurrence of most common diseases (i.e., pneumonia and anaplasmosis). Collected data were analyzed by using a linear mixed model for repeated measures, Tukey's test, and chi-squared procedures. Treatment influenced (P < 0.05) TD, FS, and FD but not CRS (P = 0.78). From EV 1 to EV 3 , the control calves had the lowest TD. The GPB group had lower FS than the control but did not differ from GP. The GPB group had lower FD means than the other two groups in EV 2 , EV 3 , and EV 4 . No differences (P > 0.05) due to treatment were observed on heart and respiratory rates, ADG, or occurrence of pneumonia and anaplasmosis. It was concluded that adoption of good practices of handling during pre-weaning period may lead to long-term positive effects.

40 CFR 61.12 - Compliance with standards and maintenance requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Provisions § 61.12 Compliance with standards and maintenance requirements. (a) Compliance with numerical... otherwise specified in an individual subpart. (b) Compliance with design, equipment, work practice or... pollution control, in a manner consistent with good air pollution control practice for minimizing emissions...

Discovering successful strategies for diabetic self-management: a qualitative comparative study

PubMed Central

Baer, Roberta; Nash, Anita; Perez, Noe

2017-01-01

Objective This project explored lifestyles of patients in good and poor control to identify naturally occurring practices and strategies that result in successful diabetes management. Research design and methods Semistructured interviews with adult patients with type 2 diabetes explored diet, food preparation, physical activity, medication use and glucose monitoring. Patients (n=56) were classified into good (A1C <7.0%), fair (7.0%8.0%) control groups and matched across groups on diabetes duration (±5 years) and medication modality (none, oral, insulin±oral) to control for non-lifestyle factors. A qualitative comparative analysis identified practices that distinguished glycemic groups. Results Good control patients were more likely to test their glucose two or more times a day and reduce their sodium intake, as well as increase fruits and vegetables and limit portion sizes, some attaining good control without exercise. Fair control patients discussed several dietary strategies including limiting sweets, drinking non-caloric beverages, reducing carbs, ‘cheating’ (eating only a few sweets/limiting carbs in one meal to have more in another meal) and tested their glucose once a day. Poor control patients were more likely to skip antidiabetic medications and not test their glucose. Conclusions Although clinical trials indicate most self-management practices have limited effectiveness over time, increased glucose monitoring is a valuable component in daily management. Research is needed on effectiveness of dietary strategies that emphasize sodium monitoring and allow some degree of cheating. Reoffering diabetes education classes and providing pill boxes as memory aids may help improve poor control. PMID:28761649

Discovering successful strategies for diabetic self-management: a qualitative comparative study.

PubMed

Weller, Susan C; Baer, Roberta; Nash, Anita; Perez, Noe

2017-01-01

This project explored lifestyles of patients in good and poor control to identify naturally occurring practices and strategies that result in successful diabetes management. Semistructured interviews with adult patients with type 2 diabetes explored diet, food preparation, physical activity, medication use and glucose monitoring. Patients (n=56) were classified into good (A1C <7.0%), fair (7.0%8.0%) control groups and matched across groups on diabetes duration (±5 years) and medication modality (none, oral, insulin±oral) to control for non-lifestyle factors. A qualitative comparative analysis identified practices that distinguished glycemic groups. Good control patients were more likely to test their glucose two or more times a day and reduce their sodium intake, as well as increase fruits and vegetables and limit portion sizes, some attaining good control without exercise. Fair control patients discussed several dietary strategies including limiting sweets, drinking non-caloric beverages, reducing carbs, 'cheating' (eating only a few sweets/limiting carbs in one meal to have more in another meal) and tested their glucose once a day. Poor control patients were more likely to skip antidiabetic medications and not test their glucose. Although clinical trials indicate most self-management practices have limited effectiveness over time, increased glucose monitoring is a valuable component in daily management. Research is needed on effectiveness of dietary strategies that emphasize sodium monitoring and allow some degree of cheating. Reoffering diabetes education classes and providing pill boxes as memory aids may help improve poor control.

Knowledge and Preventive Practices related to Avian Influenza among Poultry Workers of Kamalamai Municipality, Sindhuli, Nepal.

PubMed

Shrestha, R; Shrestha, K B; Ghimire, S; Shrestha, N

2016-01-01

Avian influenza (AI) is currently a threat to global health. Prevention and control of AI depends on the knowledge and preventive practices of the poultry workers as well as of general population. This study aims to assess knowledge and preventive practices related to AI among poultry workers. Cross-sectional study was carried out among poultry workers of Kamalamai Municipality, Sindhuli. Data was collected from randomly selected 122 respondents through face-to-face interview. The collected data was entered in Epi-data version 3.1 and analyzed in terms of descriptive statistics (proportion, 95% CI, mean and standard deviation) by using SPSS, version 20. A scoring system was used to assess knowledge and preventive practices. Out of total, 93.4% (95% CI, 87.6- 96.6%) of the respondents had heard about AI. More than half (54.9%) of the respondents had poor knowledge on AI. Only 5.3% of respondents had good preventive practice against AI. 30.3% respondents had good knowledge and good practice and 24.6% had poor knowledge as well as poor practice. 20.5% of the respondents had good practice but poor knowledge, whereas, 24.6% had good knowledge but poor practice towards prevention. The knowledge and practice of AI among poultry workers were low. The groups should be targeted for appropriate intervention based on whether they lack knowledge or practice or both.

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2011 CFR

2011-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2014 CFR

2014-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2013 CFR

2013-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2012 CFR

2012-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

PubMed

2014-06-10

The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

Quality management for the international transport of laboratory animals.

PubMed

Leary, Steven L

2008-01-01

Increased collaboration between investigators at different institutions has increased the number of laboratory animals being transported. The current system of laws and regulations governing animal shipments is inconsistent and government agencies often have areas of overlapping regulatory management. Furthermore, the lack of industry-wide shipping standards and good practices contributes to confusion among those responsible for shipment. One answer to these quality control issues would be the establishment of independent, industry-regulated 'good practices' for animal transport, similar to those used in laboratories for experimental design. These good practices could be based on the existing International Air Transport Association Live Animals Regulations, with contributions from representatives of the specialties involved. Additionally, quality control under the current system of patchwork regulations could be improved if each institution, both academic and commercial, would designate a single point of contact to follow each shipment from start to finish.

40 CFR 49.10711 - Federal Implementation Plan for the Astaris-Idaho LLC Facility (formerly owned by FMC Corporation...

Code of Federal Regulations, 2013 CFR

2013-07-01

... this section and associated air pollution control equipment, in a manner consistent with good air... practices. (iii) To the maximum extent practicable the air pollution control equipment or processes were..., considering the effect of any proposed air pollution control equipment; and (D) A description of any PM-10...

78 FR 48636 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of...-Based Preventive Controls for Human Food,'' that appeared in the Federal Register of January 16, 2013...

Evidence based vaccinology.

PubMed

Nalin, David R

2002-02-22

Evidence based vaccinology (EBV) is the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine, including pre-licensure vaccine development and post-licensure manufacture and research, and utilization of the vaccine for disease control. Vaccines, unlike most pharmaceuticals, are in a continuous process of development both before and after licensure. Changes in biologics manufacturing technology and changes that vaccines induce in population and disease biology lead to periodic review of regimens (and sometimes dosage) based on changing immunologic data or public perceptions relevant to vaccine safety and effectiveness. EBV includes the use of evidence based medicine (EBM) both in clinical trials and in national disease containment programs. The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios. EBV is increasingly based on statistically validated, clearly defined laboratory, manufacturing, clinical and epidemiological research methods and procedures, codified as good laboratory practices (GLP), good manufacturing practices (GMP), good clinical research practices (GCRP) and in clinical and public health practice (good vaccination practices, GVP). Implementation demands many data-driven decisions made by a spectrum of specialists pre- and post-licensure, and is essential to maintaining public confidence in vaccines.

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2013 CFR

2013-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2014 CFR

2014-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2011 CFR

2011-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2010 CFR

2010-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2012 CFR

2012-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Correction AGENCY... manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and... ``food-production purposes (i.e., manufacturing, processing, packing, and holding) to consistently use...

Tuberculosis awareness in Gezira, Sudan: knowledge, attitude and practice case-control survey.

PubMed

Suleiman, M M A; Sahal, N; Sodemann, M; Elsony, A; Aro, A R

2014-03-13

This case-control study aimed to assess tuberculosis (TB) awareness and its associated sociodemographic characteristics in Gezira, Sudan. New smear-positive TB patients registered in Gezira in 2010 (n = 425) and age-matched controls who attended the same health facilities for other reasons (n = 850) formed the study sample. Awareness was measured using a modified standard World Health Organization TB knowledge, attitude and practice instrument. There was no significant difference between TB cases and the controls in overall levels of TB awareness. About two-thirds of TB cases and controls had good TB awareness. Respondents' sex was associated with awareness among the controls. Age, level of education, type of residence and type of occupation were significantly associated with TB awareness, whereas marital status had no effect. The good level of TB awareness found among TB cases and controls is a baseline for further TB awareness-raising among the Gezira population.

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and... percentage of theoretical yield at appropriate phases of processing; (8) Complete labeling control records...

21 CFR 211.188 - Batch production and control records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and... percentage of theoretical yield at appropriate phases of processing; (8) Complete labeling control records...

Global perspectives on ensuring the safety of pharmaceutical products in the distribution process
.

PubMed

Jeong, Sohyun; Ji, Eunhee

2018-01-01

The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world. Advanced pharmaceutical countries and international organizations, such as the World Health Organization, European Union, Pharmaceutical Inspection Co-operation Scheme, United States of America, Canada, and Australia, which have stable good distribution practice guidelines and public confidence, were included in the analysis. The World Health Organization and European Union guidelines are models for standardized good distribution practice for nations worldwide. The United States of America has a combination of four different series of distribution practices which have a unique structure and detailed content compared to those of other countries. The Canadian guidelines focus on temperature control during storage and transportation. The Australian guidelines apply to both classes of medicinal products and medical devices and need separate standardization. Transparent information about the Internet chain, international cooperation regarding counterfeiting, a high-standard qualification of sellers and customers, and technology to track and trace the whole life cycle of drugs should be the main focus of future good distribution practice guidelines worldwide.
.

40 CFR 792.12 - Statement of compliance or non-compliance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.12 Statement... differences between the practices used in the study and those required by this part; or (c) A statement that...

40 CFR 61.349 - Standards: Closed-vent systems and control devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the unit in accordance with good engineering and safety practices for handling flammable, explosive... device shall be made as soon as practicable but no later than 5 calendar days after detection. Repair...

40 CFR 61.349 - Standards: Closed-vent systems and control devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the unit in accordance with good engineering and safety practices for handling flammable, explosive... device shall be made as soon as practicable but no later than 5 calendar days after detection. Repair...

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

PubMed

De Vos, Filip J; De Decker, Mario; Dierckx, Rudi A

2005-07-01

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.

Display aids for remote control of untethered undersea vehicles

NASA Technical Reports Server (NTRS)

Verplank, W. L.

1978-01-01

A predictor display superimposed on slow-scan video or sonar data is proposed as a method to allow better remote manual control of an untethered submersible. Simulation experiments show good control under circumstances which otherwise make control practically impossible.

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...

21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...

21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...

21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...

The contribution of arbusclar mycorrhizal fungi to the success or failure of agricultural practices

USDA-ARS?s Scientific Manuscript database

Good farming practices are conducted for a variety of reasons. Farmers now include management practices such as over wintering cover crops, reduced tillage, and crop rotation with the goals of reducing soil erosion, managing nutrient availability, building soil organic matter, controlling weeds, an...

33 CFR 159.71 - Electrical controls and conductors.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Electrical controls and... Electrical controls and conductors. Electrical controls and conductors must be installed in accordance with good marine practice. Wire must be copper and must be stranded. Electrical controls and conductors must...

33 CFR 159.71 - Electrical controls and conductors.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Electrical controls and... Electrical controls and conductors. Electrical controls and conductors must be installed in accordance with good marine practice. Wire must be copper and must be stranded. Electrical controls and conductors must...

33 CFR 159.71 - Electrical controls and conductors.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Electrical controls and... Electrical controls and conductors. Electrical controls and conductors must be installed in accordance with good marine practice. Wire must be copper and must be stranded. Electrical controls and conductors must...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2014 CFR

2014-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2010 CFR

2010-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2011 CFR

2011-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2012 CFR

2012-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2013 CFR

2013-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

Preliminary Assessment of Relative Toxicity and Mutagenic Potential of 1 Nitroso-3,5-Dinitro-1,3,5-Triazacyclohexane (Mononitroso-RDX)

DTIC Science & Technology

1984-09-01

Inhalation Toxicology, Mehlman, Crammer , and Shapiro, editors, 302-344, Pathotox Publishers, Inc., Park Forest South, Illinois (1977). 8. Shimkin, M. and G...Laboratory Studies. (3) Final Rule , Pesticide Programs; Good Laboratory Practice Standards; 48 Federal Register (FR) 53963-53969, 29 November 1983. (4...Final Rule , Toxic Substances Control; Good Laboratory Practice Standards; 48 Federal Register (FR) 53922-53944, 29 November 1983. b. Facilities were

Phlebitis: treatment, care and prevention.

PubMed

Higginson, Ray; Parry, Andrew

Peripheral venous catheter-associated phlebitis is caused by inflammation to the vein at a cannula access site. It can have a mechanical, chemical or infectious cause. Good practice when inserting a cannula, including appropriate choice of device and site, can help to prevent phlebitis. Good infection control techniques are also vital in preventing the condition. There are two phlebitis scoring systems, which should be used in routine practice to identify and treat early signs of the Peripheral venous cannulation

[Relationship between pharmaceutical industry and the French government during the last two centuries].

PubMed

Bonnemain, Henri; Bonnemain, Bruno

2002-01-01

Between the law of germinal an XI and the 1941 law, the relationship between the pharmaceutical industry and the French government were driven by the official practice of pharmacy. The State trues pharmacist who has to contrôle financially and deontologically his company. After 1941, the State will more and more regulate and control all the activities of the pharmaceutical products industry due to the major financial impact of these products on Health Care and Social Security budgets. French State will be progressively concerned with medical information and good practices (good manufacturing practices, good laboratory practices...) It will also regulate the pricing of new drugs, the development process and will encourage the marketing of innovative products. These rules, on the basis of the European directive of 1965, will be more or less harmonized for all European countries. Since 1989, this harmonization process is looking for an expansion outside of Europe, at least for the marketing authorization, in order to facilitate the registration of innovative products in all countries. One can then observe on a period of two centuries the evolution from freedom of the pharmaceutical industry more and more to a strict controlled freedom.

33 CFR 159.71 - Electrical controls and conductors.

Code of Federal Regulations, 2010 CFR

2010-07-01

... conductors. 159.71 Section 159.71 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND... Electrical controls and conductors. Electrical controls and conductors must be installed in accordance with good marine practice. Wire must be copper and must be stranded. Electrical controls and conductors must...

33 CFR 159.71 - Electrical controls and conductors.

Code of Federal Regulations, 2011 CFR

2011-07-01

... conductors. 159.71 Section 159.71 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND... Electrical controls and conductors. Electrical controls and conductors must be installed in accordance with good marine practice. Wire must be copper and must be stranded. Electrical controls and conductors must...

40 CFR 792.107 - Test, control, and reference substance handling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Test, control, and reference substance handling. 792.107 Section 792.107 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

Barriers to standard precautions adherence in a dental school in Iran: a qualitative study.

PubMed

Hedayati, Hamidreza; Marjadi, Brahmaputra; Askarian, Mehrdad

2014-07-01

Setting up good infection control practices in educational institutions is crucial in shaping future health professionals. The implementation of standard precautions (SPs) in Iranian dental schools has not been explored qualitatively to identify barriers to good practice. Twelve focus group discussions and 8 semistructured interviews were conducted with students, residents, and staff members (n = 83) of the Shiraz University of Medical Sciences Dental School. The interview guide addressed performance, subjective norms, and behavioral control domains of SP-related behaviors. Thematic analysis was performed manually to identify barriers to SP practices. Proximal factors of poor SP adherence were a lack of knowledge and technical difficulties. These factors were compounded by intermediate factors in the work environment: lack of facilities, heavy workload, patient expectations, interprofessional conflicts, and lack of good role models. Two underlying distal factors were financial issues and unsupportive organizational culture. The social constructionism theory was useful in analyzing the situation and suggesting an educational approach as part of the solution. Complex and intertwined barriers of SP adherence were found in this dental school. A social construction approach may assist in addressing these problems by shifting the culture through education to construct a contextual new knowledge. Further research in medical sociology of SP practices would be useful. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

21 CFR 110.80 - Processes and controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD Production and Process Controls § 110.80 Processes and controls. All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in...

40 CFR 63.342 - Standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... to the requirements of this subpart, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for..., infrequent, and unavoidable failure of air pollution control equipment, process equipment, or a process to...

40 CFR 63.1250 - Applicability.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize... were caused by a sudden, infrequent, and unavoidable failure of air pollution control and monitoring...

40 CFR 63.1250 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize... were caused by a sudden, infrequent, and unavoidable failure of air pollution control and monitoring...

40 CFR 63.1250 - Applicability.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize... were caused by a sudden, infrequent, and unavoidable failure of air pollution control and monitoring...

40 CFR 63.342 - Standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... to the requirements of this subpart, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for..., infrequent, and unavoidable failure of air pollution control equipment, process equipment, or a process to...

40 CFR 63.1250 - Applicability.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize... were caused by a sudden, infrequent, and unavoidable failure of air pollution control and monitoring...

Design guidelines for assessing and controlling spacecraft charging effects

NASA Technical Reports Server (NTRS)

Purvis, C. K.; Garrett, H. B.; Whittlesey, A. C.; Stevens, N. J.

1984-01-01

The need for uniform criteria, or guidelines, to be used in all phases of spacecraft design is discussed. Guidelines were developed for the control of absolute and differential charging of spacecraft surfaces by the lower energy space charged particle environment. Interior charging due to higher energy particles is not considered. A guide to good design practices for assessing and controlling charging effects is presented. Uniform design practices for all space vehicles are outlined.

Design guidelines for assessing and controlling spacecraft charging effects

NASA Technical Reports Server (NTRS)

Purvis, C. K.; Garrett, H. B.; Whittlesey, A.; Stevens, N. J.

1985-01-01

The need for uniform criteria, or guidelines, to be used in all phases of spacecraft design is discussed. Guidelines were developed for the control of absolute and differential charging of spacecraft surfaces by the lower energy space charged particle environment. Interior charging due to higher energy particles is not considered. A guide to good design practices for assessing and controlling charging effects is presented. Uniform design practices for all space vehicles are outlined.

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160... procedures, or other laboratory control mechanisms required by this subpart, including any change in such...

Influence of farm management upon arbuscular mycorrhizal fungi

USDA-ARS?s Scientific Manuscript database

Good farming practices are conducted for a variety of reasons. Farmers now include management practices such as over wintering cover crops, reduced tillage, and crop rotation with the goals of reducing soil erosion, managing nutrient availability, building soil organic matter, controlling weeds, an...

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule.

PubMed

1993-08-03

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.

21 CFR 58.105 - Test and control article characterization.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Test and control article characterization. 58.105... GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.105 Test and control article characterization. (a) The identity, strength, purity, and composition or other...

21 CFR 58.105 - Test and control article characterization.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Test and control article characterization. 58.105... GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.105 Test and control article characterization. (a) The identity, strength, purity, and composition or other...

21 CFR 58.105 - Test and control article characterization.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Test and control article characterization. 58.105... GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.105 Test and control article characterization. (a) The identity, strength, purity, and composition or other...

21 CFR 58.105 - Test and control article characterization.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Test and control article characterization. 58.105... GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.105 Test and control article characterization. (a) The identity, strength, purity, and composition or other...

21 CFR 58.105 - Test and control article characterization.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Test and control article characterization. 58.105... GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.105 Test and control article characterization. (a) The identity, strength, purity, and composition or other...

21 CFR 1271.250 - Labeling controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

21 CFR 1271.250 - Labeling controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

21 CFR 1271.250 - Labeling controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

21 CFR 1271.250 - Labeling controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

21 CFR 1271.250 - Labeling controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

An assessment of workplace programmes designed to control inhalation risks using respiratory protective equipment.

PubMed

Bell, Nikki; Vaughan, Nicholas P; Morris, Len; Griffin, Peter

2012-04-01

Few studies have assessed respiratory protective equipment (RPE) failures at the organizational level despite evidence to suggest that compliance with good practice may be low. The aim of this study was to develop an understanding of what current RPE programmes look like across industry and how this compares with good practice. Twenty cross-industry site visits were conducted with companies that had RPE programmes in place. Visits involved management interviews to explore current RPE systems and procedures and the decision making underpinning these. Observations of RPE operatives were included followed by short interviews to discuss the behaviours observed. Post-site assessments jointly undertaken by an RPE scientist and psychologist produced ratings for each site on six critical aspects of RPE programmes (knowledge/awareness, selection, use, training/information, supervision, and storage/cleaning/maintenance). Overall ratings for theoretical competence (i.e. management knowledge of RPE) and practical control (i.e. actual RPE practice on the shop floor) were also given. Qualitative analysis was performed on all interview data. The performance of RPE programmes varied across industry. Fewer than half the companies visited were considered to have an acceptable level of theoretical competence and practical control. Four distinct groups emerged from the 20 sites studied, ranging from Learners (low theoretical competence and practical control--four sites), Developers (acceptable theoretical competence and low practical control--five sites), and Fortuitous (low theoretical competence and acceptable practical control--two sites), to Proficient (acceptable theoretical competence and practical control--nine sites). None of the companies visited were achieving optimal control through the use of RPE. Widespread inadequacies were found with programme implementation, particularly training, supervision, and maintenance. Our taxonomy based on the four groups (Learners, Developers, Fortuitous, and Proficient) provided a useful expert-informed tool for explaining the variation in performance of RPE programmes across industry. Although further research and development are required, this taxonomy offers a useful starting point for the development of practical tools that may assist managers in making the much-needed improvements to all facets of programme implementation, particularly training, supervision, and maintenance.

A helping hand for infection control.

PubMed

Allen, Mike

2004-09-01

Despite considerable awareness amongst the healthcare community about the importance of hand hygiene in controlling Healthcare Acquired Infections (HAIs), the problem persists. Mike Allen of Dart Valley Systems explores the issues surrounding good hand hygiene practice in UK hospitals.

Promotion, prevention and protection: interventions at the population- and community-levels for mental, neurological and substance use disorders in low- and middle-income countries.

PubMed

Petersen, Inge; Evans-Lacko, Sara; Semrau, Maya; Barry, Margaret M; Chisholm, Dan; Gronholm, Petra; Egbe, Catherine O; Thornicroft, Graham

2016-01-01

In addition to services within the health system, interventions at the population and community levels are also important for the promotion of mental health, primary prevention of mental, neurological and substance use (MNS) disorders, identification and case detection of MNS disorders; and to a lesser degree treatment, care and rehabilitation. This study aims to identify "best practice" and "good practice" interventions that can feasibly be delivered at these population- and community-levels in low- and middle-income countries (LMICs), to aid the identification of resource efficiencies and allocation in LMICs. A narrative review was conducted given the wide range of relevant interventions. Expert consensus was used to identify "best practice" at the population-level on the basis of existing quasi-experimental natural experiments and cost effectiveness, with small scale emerging and promising evidence comprising "good practice". At the community-level, using expert consensus, the ACE (Assessing Cost-Effectiveness in Prevention Project) grading system was used to differentiate "best practice" interventions with sufficient evidence from "good practice" interventions with limited but promising evidence. At the population-level, laws and regulations to control alcohol demand and restrict access to lethal means of suicide were considered "best practice". Child protection laws, improved control of neurocysticercosis and mass awareness campaigns were identified as "good practice". At the community level, socio-emotional learning programmes in schools and parenting programmes during infancy were identified as "best practice". The following were all identified as "good practice": Integrating mental health promotion strategies into workplace occupational health and safety policies; mental health information and awareness programmes as well as detection of MNS disorders in schools; early child enrichment/preschool educational programs and parenting programs for children aged 2-14 years; gender equity and/or economic empowerment programs for vulnerable groups; training of gatekeepers to identify people with MNS disorders in the community; and training non-specialist community members at a neighbourhood level to assist with community-based support and rehabilitation of people with mental disorders. Interventions provided at the population- and community-levels have an important role to play in promoting mental health, preventing the onset, and protecting those with MNS disorders. The importance of inter-sectoral engagement and the need for further research on interventions at these levels in LMICs is highlighted.

75 FR 65663 - Gilbert Eugene Johnson, M.D.; Revocation of Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-26

... administering of controlled or narcotic drugs''; and (3) Respondent ``prescribed, dispensed or administered controlled substances or narcotic drugs in excess of the amount considered good medical practice or prescribed, dispensed or administered controlled substances or narcotic drugs without medical need.'' Id. at...

29 CFR 1910.1051 - 1,3-Butadiene.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., duration, and results of samples taken; (E) Type of protective devices worn, if any; and (F) Name, social... social security number of the employee; (B) Physician's or other licensed health care professional's...: Good industrial hygiene practices recommend that engineering and work practice controls be used to...

Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

PubMed

Carroll, Erica Eggers

2016-01-01

Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed.

Editorial: A Note on Good Research Practice

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dooley, James J.

Good scientific practice and research misconduct have been concerns of mine for more than a decade (Dooley and Kerch, 2000) and in my role as an editor of the International Journal of Greenhouse Gas Control, I feel it is time to speak up and at the very least share my concerns and suggestions as they relate to the integrity of the research published in this journal. Rather than wait to write an editorial on good research practices in response to a major incident, I thought it might be best to be proactive and address some of the trends we seemore » in submissions to this peer reviewed journal and to offer some suggestions for improvement improving the level of scholarship in some – but by no means all – of the papers submitted.« less

40 CFR 160.107 - Test, control, and reference substance handling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Test, control, and reference substance handling. 160.107 Section 160.107 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.107 Test...

40 CFR 792.47 - Facilities for handling test, control, and reference substances.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Facilities for handling test, control, and reference substances. 792.47 Section 792.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities...

42 CFR 405.201 - Scope of subpart and definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

...). (b) Definitions. As used in this subpart— Class I refers to devices for which the general controls of the Food, Drug, and Cosmetic Act, such as adherence to good manufacturing practice regulations, are... addition to general controls, require special controls, such as performance standards or postmarket...

42 CFR 405.201 - Scope of subpart and definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

...). (b) Definitions. As used in this subpart— Class I refers to devices for which the general controls of the Food, Drug, and Cosmetic Act, such as adherence to good manufacturing practice regulations, are... addition to general controls, require special controls, such as performance standards or postmarket...

42 CFR 405.201 - Scope of subpart and definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

...). (b) Definitions. As used in this subpart— Class I refers to devices for which the general controls of the Food, Drug, and Cosmetic Act, such as adherence to good manufacturing practice regulations, are... addition to general controls, require special controls, such as performance standards or postmarket...

40 CFR 180.1101 - Parasitic (parasitoid) and predatory insects; exemption from the requirement of a tolerance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... with good agricultural and pest control practices to control insect pests of stored raw whole grains... PESTICIDE CHEMICAL RESIDUES IN FOOD Exemptions From Tolerances § 180.1101 Parasitic (parasitoid) and...

40 CFR 180.1101 - Parasitic (parasitoid) and predatory insects; exemption from the requirement of a tolerance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... with good agricultural and pest control practices to control insect pests of stored raw whole grains... PESTICIDE CHEMICAL RESIDUES IN FOOD Exemptions From Tolerances § 180.1101 Parasitic (parasitoid) and...

40 CFR 180.1101 - Parasitic (parasitoid) and predatory insects; exemption from the requirement of a tolerance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... with good agricultural and pest control practices to control insect pests of stored raw whole grains... PESTICIDE CHEMICAL RESIDUES IN FOOD Exemptions From Tolerances § 180.1101 Parasitic (parasitoid) and...

40 CFR 180.1101 - Parasitic (parasitoid) and predatory insects; exemption from the requirement of a tolerance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... with good agricultural and pest control practices to control insect pests of stored raw whole grains... PESTICIDE CHEMICAL RESIDUES IN FOOD Exemptions From Tolerances § 180.1101 Parasitic (parasitoid) and...

40 CFR 180.1101 - Parasitic (parasitoid) and predatory insects; exemption from the requirement of a tolerance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... with good agricultural and pest control practices to control insect pests of stored raw whole grains... PESTICIDE CHEMICAL RESIDUES IN FOOD Exemptions From Tolerances § 180.1101 Parasitic (parasitoid) and...

Controlling Household Pests. Home and Garden Bulletin No. 96.

ERIC Educational Resources Information Center

Department of Agriculture, Washington, DC.

Reviewed are good housekeeping practices for eliminating and preventing the return of common household pests. Each category of pest is described individually including a description of their habits, the damage they do, and approved methods of control. (SL)

78 FR 64735 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

...The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.

Knowledge, attitude and practice of exercise for plasma blood glucose control among patients with type-2 diabetes.

PubMed

Awotidebe, Taofeek O; Adedoyin, Rufus A; Afolabi, Mubaraq A; Opiyo, Rose

2016-01-01

Exercise plays significant role in the health outcomes of patients with diabetes, however, little is known about patients' knowledge of exercise for plasma blood glucose control among patients with type-2 diabetes (T2D). This study investigated knowledge, attitude and practice (KAP) of exercise for plasma blood glucose control among patients with T2D. This cross-sectional study recruited 299 patients with T2D (male=105; female=194) from selected government hospitals in Osun State, Nigeria using purposive sampling technique. Validated questionnaires were used to assess of exercise for plasma blood glucose control and socioeconomic status (SES) of the patients. Data were analysed using descriptive and inferential statistics. Alpha level was set at <0.05. The mean age of respondents was 51.9±9.8 years. A majority, 245(81.9%) were married individuals and more than half, 195(65.3%) were in the low SES. One hundred and forty-eight (49.5%) had good knowledge of exercise whilst 269(90.0%) had negative attitude to exercise practice. Less than a third, 82(27.4%) engaged in exercise practice for plasma blood glucose control. There was significant association between knowledge and practice of exercise ((2)=12.535; p=0.002). Furthermore, significant associations were found between knowledge and gender ((2)=11.453; p=0.003), and socioeconomic status ((2)=29.127, p=0.001) but not associated with attitude towards exercise (p>0.05). Patients with demonstrated good knowledge of exercise for plasma blood glucose control but reported negative attitude and poor practice of exercise. Copyright © 2016. Published by Elsevier Ltd.

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

21 CFR 58.107 - Test and control article handling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Test and control article handling. 58.107 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.107 Test and control article handling. Procedures shall be established for a system for the handling of the test and...

Knowledge, attitude and practice of community drug distributors' about onchocerciasis and community directed treatment with ivermectin in Quara district, North Western Ethiopia.

PubMed

Weldegebreal, Fitsum; Medhin, Girmay; Weldegebriel, Zemichael; Legesse, Mengistu

2016-04-06

Onchocerciasis is one of the most important public health problems over large areas of tropical Africa countries including Ethiopia. The African Program for Onchocerciasis Control (APOC) has been working with ultimate goal of reducing the public health and socio-economic problems of onchocerciasis through administration of the tablet for continuous 12-15 years using the strategy of yearly community-directed treatment with ivermectin (CDTI) in endemic areas of Africa to kill the microfilariae that invade the eyes and are present in the skin to be transported to another victim by the black fly. The objective of this study was to assess knowledge, attitude and practice of community drug distributors (CDDs) towards onchocerciasis and CDTI in Quara district. Of all the study participating CDD 11.4% (9/79) said that they knew about the etiology of the disease, 35.4% (28/79) had good level of knowledge, 19 (24.1%) had good level of positive attitude and 18 (22.8%) had good level of positive practice about onchocerciasis. Similarly, 45.6% (36/79), 81.0% (64/79) and 29.1% (23/79) had good level of knowledge, attitude and practice about CDTIP, respectively. Being a female CDD (adjusted OR 7.246, P = 0.035, 95% CI 1.147, 45.455) and being older than 35 years (adjusted OR 8.435, P = 0.001, 95% CI 4.53, 9.003) were significantly associated with the likelihood of having good level of knowledge about the disease. Although onchocerciasis is endemic in Quara district, large proportion of the CDDs had misconceptions about its causation, transmission and prevention. Therefore, CDTIP for onchocerciasis control need to be supported by proper and continuous training, and health education about different aspects of the disease.

Patient safety and infection control: bases for curricular integration.

PubMed

Silva, Andréa Mara Bernardes da; Bim, Lucas Lazarini; Bim, Felipe Lazarini; Sousa, Alvaro Francisco Lopes; Domingues, Pedro Castania Amadio; Nicolussi, Adriana Cristina; Andrade, Denise de

2018-05-01

To analyze curricular integration between teaching of patient safety and good infection prevention and control practices. Integrative review, designed to answer the question: "How does curricular integration of content about 'patient safety teaching' and content about 'infection prevention and control practices' occur in undergraduate courses in the health field?". The following databases were searched for primary studies: CINAHL, LILACS, ScienceDirect, Web of Science, Scopus, Europe PMC and MEDLINE. The final sample consisted of 13 studies. After content analysis, primary studies were grouped into two subject categories: "Innovative teaching practices" and "Curricular evaluation. Patient safety related to infection prevention and control practices is present in the curriculum of health undergraduate courses, but is not coordinated with other themes, is taught sporadically, and focuses mainly on hand hygiene.

21 CFR 226.40 - Production and control procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production and control procedures. 226.40 Section 226.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control...

40 CFR 63.11115 - What are my general duties to minimize emissions?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Dispensing Facilities Emission Limitations and Management Practices § 63.11115 What are my general duties to... consistent with safety and good air pollution control practices for minimizing emissions. Determination of... and maintenance procedures, review of operation and maintenance records, and inspection of the source...

40 CFR 63.11115 - What are my general duties to minimize emissions?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Dispensing Facilities Emission Limitations and Management Practices § 63.11115 What are my general duties to... consistent with safety and good air pollution control practices for minimizing emissions. Determination of... and maintenance procedures, review of operation and maintenance records, and inspection of the source...

40 CFR 63.11115 - What are my general duties to minimize emissions?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Dispensing Facilities Emission Limitations and Management Practices § 63.11115 What are my general duties to... consistent with safety and good air pollution control practices for minimizing emissions. Determination of... and maintenance procedures, review of operation and maintenance records, and inspection of the source...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2011 CFR

2011-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of...

40 CFR 63.1544 - Standards for fugitive dust sources.

Code of Federal Regulations, 2014 CFR

2014-07-01

... associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whether such operation.... 63.1544 Section 63.1544 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR...

40 CFR 63.1544 - Standards for fugitive dust sources.

Code of Federal Regulations, 2012 CFR

2012-07-01

... associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whether such operation.... 63.1544 Section 63.1544 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR...

40 CFR 63.1544 - Standards for fugitive dust sources.

Code of Federal Regulations, 2013 CFR

2013-07-01

... associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whether such operation....1544 Section 63.1544 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... all times to indicate their contents and, when necessary, the phase of processing of the batch. (b...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2011 CFR

2011-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... all times to indicate their contents and, when necessary, the phase of processing of the batch. (b...

21 CFR 184.1792 - Sodium sesquicarbonate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... good manufacturing practice utilizes a level of the ingredient sufficient to control lactic acid prior to pasteurization and churning of cream into butter. (d) Prior sanctions for this ingredient...

21 CFR 211.130 - Packaging and labeling operations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control § 211.130 Packaging and labeling operations. There shall be written procedures designed to... manufacture and control of the batch. (d) Examination of packaging and labeling materials for suitability and...

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule.

PubMed

2012-03-20

The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

Metrics, Business Plans, and the Vanishing Public Good

ERIC Educational Resources Information Center

Tuchman, Gaye

2011-01-01

For at least 30 years, professional work has been changing. Even such once-elite professionals as doctors, lawyers, and professors have become subject to significant control. Single-practitioner medical practices have given way to group practices subject to the rules of insurance plans; lawyers join mammoth firms where paralegals time the steps…

Knowledge and practice on prevention of diabetes mellitus among Diabetes mellitus family members, in suburban cities in Ethiopia.

PubMed

Wolde, Mistire; Berhe, Nega; van Die, Irma; Medhin, Girmay; Tsegaye, Aster

2017-11-02

Diabetes mellitus (DM) is one of the serious non communicable diseases worldwide. Presence of DM patient in a family may be considered as risk factor for other family members to acquire the disease, due to DM inheritance nature and/or similar life style pattern among family members. This paper assessed awareness of DM patients' family members (DMPFMs) about DM occurrence and prevention. A cross sectional study was conducted in 2014 in two suburban cities of Ethiopia, namely Kemisse, and Kombolcha using an interviewer administered questionnaire among primary or secondary degree DMPFMs and controls. Based on eligibility criteria study participants were selected by health extension workers on house to house visit. Data were analyzed using SPSS version 20, and P value less than 0.05 considered as statistically significant. Of the total 347 study participants, 45.5% (n = 158) had DMPFMs. Majority, 60.8% of DMPFMs and 73.0% of controls were males. Mean age of DMPFMs (30.06 years) was less than that of the controls (37.38 years). On living style, 51.9% DMPFMs, and 42.8% of controls were single. In both study groups, the majority of study participants attended grade 7-12. The likelihood of having good level of knowledge among DMPFMs were 2.94 times (AOR = 2.94 95% CI 1.87-4.86) higher compared to those who did not. Those attaining higher educational levels were 3.41 times (AOR = 3.41, 95% CI 1.31-8.91) more likely to have good level of knowledge, as compared to those who were unable to read and write. The likelihood of having good level of positive practice among DMPFMs were 3.38 times (AOR = 3.38% CI 2.05-5.58) higher as compared to controls. Participants who were living in Kombolcha were 2.33 times (AOR = 2.33 95% CI 1.31-4.12) more likely to have good level of practice, as compared to individuals from Kemisse. Diabetes mellitus family members in the Ethiopian suburban cities Kemisse, and Kombolcha had better knowledge and practice about DM compared to controls. But, the overall awareness about DM occurrence and prevention was relatively low. Thus, DM awareness campaigns should be strongly pursued regardless of family history and educational background to prevent further increase of DM in Ethiopia.

Method and apparatus for controlling LCL converters using asymmetric voltage cancellation techniques

DOEpatents

Wu, Hunter; Sealy, Kylee Devro; Sharp, Bryan Thomas; Gilchrist, Aaron

2016-01-26

A method and apparatus for LCL resonant converter control utilizing Asymmetric Voltage Cancellation is described. The methods to determine the optimal trajectory of the control variables are discussed. Practical implementations of sensing load parameters are included. Simple PI, PID and fuzzy logic controllers are included with AVC for achieving good transient response characteristics with output current regulation.

40 CFR 160.47 - Facilities for handling test, control, and reference substances.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Facilities for handling test, control, and reference substances. 160.47 Section 160.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.47 Facilities...

21 CFR 211.113 - Control of microbiological contamination.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Control of microbiological contamination. 211.113 Section 211.113 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...

Collaborative evaluation of a high school prevention curriculum: How methods of collaborative evaluation enhanced a randomized control trial to inform program improvement.

PubMed

Orsini, Muhsin Michael; Wyrick, David L; Milroy, Jeffrey J

2012-11-01

Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome variables that can be used for program improvement. Throughout this project there were many examples of client learning from evaluator and evaluator learning from client. This article presents convincing evidence that collaborative evaluation can improve the design, implementation, and findings of the randomized control trial. Throughout this paper, we discuss many examples of good science, good evaluation, and other practical benefits of practicing collaborative evaluation. Ultimately, the authors created the term pre-formative evaluation to describe the period prior to data collection and before program implementation, when collaborative evaluation can inform program improvement. Copyright © 2012 Elsevier Ltd. All rights reserved.

[Medical professionals on the subject of their core values: the importance of practice-based stories and intrinsic motivation].

PubMed

Witman, Yolande; van den Kerkhof, Peter C M; Braat, Didi D M

2013-01-01

In the current system for guaranteeing quality of care, emphasis is placed firmly on external control of professionals. We looked for a way to appeal to the intrinsic motivation of medical professionals and to discover what they mean by 'good work'. This was achieved with the aid of reflective sessions using the toolkit 'Good Work': in four sessions three different groups of medical professionals (medical department chairs, residents and interns) from a Dutch university hospital reflected on the topics 'excellence', 'moral responsibility' and 'personal engagement'. The participants exchanged practice-based stories during the sessions. The most important theme was moral responsibility, with its accompanying dilemmas. The sessions gave rise to feelings of mutual acknowledgement, recognition, inspiration and motivation. Sharing meaningful practice-based stories can be considered as a 'moment of learning', strengthening professional identity and stimulating intrinsic motivation. More space for this form of reflection might restore the balance with external control systems.

Compliance With Recommended Food Safety Practices in Television Cooking Shows.

PubMed

Cohen, Nancy L; Olson, Rita Brennan

Examine compliance with recommended food safety practices in television cooking shows. Using a tool based on the Massachusetts Food Establishment Inspection Report, raters examined 39 episodes from 10 television cooking shows. Chefs demonstrated conformance with good retail practices for proper use and storage of utensils in 78% of episodes; preventing contamination (62%), and fingernail care (82%). However, 50% to 88% of episodes were found to be out of compliance with other personal hygiene practices, proper use of gloves and barriers (85% to 100%), and maintaining proper time and temperature controls (93%). Over 90% failed to conform to recommendations regarding preventing contamination through wiping cloths and washing produce. In only 13% of episodes were food safety practices mentioned. There appears to be little attention to food safety during most cooking shows. Celebrity and competing chefs have the opportunity to model and teach good food safety practices for millions of viewers. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

40 CFR Table 3 to Subpart Bbbbbb... - Applicability of General Provisions

Code of Federal Regulations, 2012 CFR

2012-07-01

... Maintain monitoring system in a manner consistent with good air pollution control practices Yes. § 63.8(c...) Maintenance records Recordkeeping of maintenance on air pollution control and monitoring equipment Yes. § 63... (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE...

40 CFR 265.1080 - Applicability.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 264.1080 - Applicability.

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air pollution... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 264.1080 - Applicability.

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air pollution... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 265.1080 - Applicability.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 264.1080 - Applicability.

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air pollution... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 265.1080 - Applicability.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR Table 3 to Subpart Bbbbbb... - Applicability of General Provisions

Code of Federal Regulations, 2011 CFR

2011-07-01

... Maintain monitoring system in a manner consistent with good air pollution control practices Yes. § 63.8(c...) Maintenance records Recordkeeping of maintenance on air pollution control and monitoring equipment Yes. § 63... (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE...

40 CFR Table 3 to Subpart Bbbbbb... - Applicability of General Provisions

Code of Federal Regulations, 2014 CFR

2014-07-01

... Maintain monitoring system in a manner consistent with good air pollution control practices Yes. § 63.8(c...) Maintenance records Recordkeeping of maintenance on air pollution control and monitoring equipment Yes. § 63... (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE...

40 CFR 60.4333 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2013 CFR

2013-07-01

... stationary combustion turbine, air pollution control equipment, and monitoring equipment in a manner consistent with good air pollution control practices for minimizing emissions at all times including during... of Performance for Stationary Combustion Turbines General Compliance Requirements § 60.4333 What are...

40 CFR 60.4333 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

... stationary combustion turbine, air pollution control equipment, and monitoring equipment in a manner consistent with good air pollution control practices for minimizing emissions at all times including during... of Performance for Stationary Combustion Turbines General Compliance Requirements § 60.4333 What are...

40 CFR 60.4333 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2014 CFR

2014-07-01

... stationary combustion turbine, air pollution control equipment, and monitoring equipment in a manner consistent with good air pollution control practices for minimizing emissions at all times including during... of Performance for Stationary Combustion Turbines General Compliance Requirements § 60.4333 What are...

40 CFR 63.6605 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require you to make any further efforts to reduce...

21 CFR 1271.260 - Storage.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

21 CFR 1271.260 - Storage.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

21 CFR 1271.260 - Storage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

21 CFR 1271.260 - Storage.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

Quality Risk Management: Putting GMP Controls First.

PubMed

O'Donnell, Kevin; Greene, Anne; Zwitkovits, Michael; Calnan, Nuala

2012-01-01

This paper presents a practical way in which current approaches to quality risk management (QRM) may be improved, such that they better support qualification, validation programs, and change control proposals at manufacturing sites. The paper is focused on the treatment of good manufacturing practice (GMP) controls during QRM exercises. It specifically addresses why it is important to evaluate and classify such controls in terms of how they affect the severity, probability of occurrence, and detection ratings that may be assigned to potential failure modes or negative events. It also presents a QRM process that is designed to directly link the outputs of risk assessments and risk control activities with qualification and validation protocols in the GMP environment. This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered to be any control that is put in place to assure product quality and regulatory compliance. This improved approach is also based on how the detectability of risks is assessed. This is important because when producing medicines, it is not always good practice to place a high reliance upon detection-type controls in the absence of an adequate level of assurance in the manufacturing process that leads to the finished medicine.

Development of a Checklist for Assessing Good Hygiene Practices of Fresh-Cut Fruits and Vegetables Using Focus Group Interviews.

PubMed

Araújo, Jane A M; Esmerino, Erick A; Alvarenga, Verônica O; Cappato, Leandro P; Hora, Iracema C; Silva, Marcia Cristina; Freitas, Monica Q; Pimentel, Tatiana C; Walter, Eduardo H M; Sant'Ana, Anderson S; Cruz, Adriano G

2018-03-01

This study aimed to develop a checklist for good hygiene practices (GHP) for raw material of vegetable origin using the focus groups (FGs) approach (n = 4). The final checklist for commercialization of horticultural products totaled 28 questions divided into six blocks, namely: water supply; hygiene, health, and training; waste control; control of pests; packaging and traceability; and hygiene of facilities and equipment. The FG methodology was efficient to elaborate a participatory and objective checklist, based on minimum hygiene requirements, serving as a tool for diagnosis, planning, and training in GHP of fresh vegetables, besides contributing to raise awareness of the consumers' food safety. The FG methodology provided useful information to establish the final checklist for GHP, with easy application, according to the previous participants' perception and experience.

Protecting children and families from tobacco and tobacco-related NCDs in the Western Pacific: good practice examples from Malaysia, Philippines and Singapore.

PubMed

David, A M; Mercado, S P; Klein, J D; Kaundan, M s/o K; Koong, H N; Garcia, E

2017-09-01

Non-communicable diseases (NCDs) are generally considered diseases of adulthood, but NCD risk factors like tobacco use often are taken up during childhood and adolescence, and second-hand smoke exposure affects child survival and development. At a regional meeting of the Asia Pacific Child and Family Health Alliance for Tobacco Control, members reviewed existing good practices of child-focused tobacco control approaches using health promotion strategies. These interventions were implemented nationally in Malaysia, the Philippines and Singapore. Three good practice national examples were identified that focused on creating supportive tobacco-free environments and upgrading cessation skills among paediatricians. These country examples highlight strategic areas to protect children and families from the harms of tobacco, as part of NCD prevention and control. Training paediatricians in brief cessation advice has enabled them to address tobacco-using parents. Fully enforcing smoke-free public areas has led to an increase in smoke-free homes. The Tobacco Free Generation is a tobacco control 'endgame' strategy that taps into a social movement to deglamorize tobacco use and empower youth born in and after year 2000 to reject tobacco and nicotine addiction. Tobacco control is pivotal in the fight against NCDs; health promotion strategies to protect children and youth from tobacco have a critical role to play in NCD prevention and control. Frontline health workers, including primary care paediatricians, need to step up and actively advocate for full implementation of the WHO Framework Convention on Tobacco Control, including tobacco tax increases and smoke-free areas, while monitoring patients and their parents for tobacco use and second-hand smoke exposure, preventing adolescent smoking uptake, and offering cessation support. A life-course approach incorporating child-focused efforts to prevent initiation of smoking and second-hand smoke exposure with measures promoting cessation among parents will offer the greatest chance of overcoming future tobacco-related NCD burden. © 2017 John Wiley & Sons Ltd.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2005-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

Cost Estimation and Control for Flight Systems

NASA Technical Reports Server (NTRS)

Hammond, Walter E.; Vanhook, Michael E. (Technical Monitor)

2002-01-01

Good program management practices, cost analysis, cost estimation, and cost control for aerospace flight systems are interrelated and depend upon each other. The best cost control process cannot overcome poor design or poor systems trades that lead to the wrong approach. The project needs robust Technical, Schedule, Cost, Risk, and Cost Risk practices before it can incorporate adequate Cost Control. Cost analysis both precedes and follows cost estimation -- the two are closely coupled with each other and with Risk analysis. Parametric cost estimating relationships and computerized models are most often used. NASA has learned some valuable lessons in controlling cost problems, and recommends use of a summary Project Manager's checklist as shown here.

Improving infection control in general practice.

PubMed

Farrow, S C; Zeuner, D; Hall, C

1999-03-01

Infection control measures in the health care setting should protect patients and staff from cross-infection. The prevention of harm is an essential part of good medical practice and failure might result in professional misconduct proceedings by the General Medical Council (GMC) and prosecution under the Health and Safety at Work legislation, as well as civil liability. For a health authority, overall responsibility for public health includes arrangements for the control of communicable diseases and infection in hospital and the community (NHS Management Executive, 1993), a function usually led by the Consultant in Communicable Disease Control (CCDC). This paper describes one district's collaborative approach between public health and GPs to assess and improve local infection control standards.

Oral health knowledge and practices of dentists practicing in a teaching hospital in Nigeria.

PubMed

Jegede, Akinlolu Tolulope; Oyedele, Titus Ayodeji; Sodipo, Babasola Olufemi; Folayan, Morenike Oluwatoyin

2016-01-01

To assess the oral health practices and knowledge of practicing dentists at a tertiary health institution in Nigeria, and the possible association of age and sex with caries prevention practices. A cross-sectional study was conducted. All practicing dentists in the institution were eligible to participate in the study. A questionnaire that assessed oral health practices and knowledge was administered. Respondents were expected to select the most appropriate responses that reflected their knowledge of oral health practices and caries prevention practices. Questions included assessment of knowledge and practice of tooth brushing, flossing, refined carbohydrate intake, and dental service utilization. Participants' responses were scored and dichotomized to poor and good knowledge, and poor and good practices, using the median scores. Bivariate analysis was conducted to identify factors associated with good and poor oral health practices, and good and poor knowledge. Fifty-two eligible study participants were accessible at the time of questionnaire administration. Only 46 respondents returned the filled questionnaire giving a response rate of 88.5%. The age of respondents ranged between 25 and 48 years. The majority of respondents had good oral health practices (65.2%) and good oral health knowledge (85%). However, few respondents had good caries prevention practices: 39.2% brushed at least twice daily, 45.7% took refined carbohydrate less than once daily, 36.9% used dental floss at least once daily, and 60.9% undertook preventive dental care. The correlation between the dentists' oral health knowledge score and oral health practices score was insignificant (0.90; P = 0.55). A large number of dentists practicing in the tertiary hospital had good oral health practices and good oral health knowledge. However, the proportion of dentists with good caries prevention practices was low.

21 CFR 58.113 - Mixtures of articles with carriers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Mixtures of articles with carriers. 58.113 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.113 Mixtures of articles with carriers. (a) For each test or control article that is mixed with a carrier, tests...

21 CFR 58.113 - Mixtures of articles with carriers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Mixtures of articles with carriers. 58.113 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.113 Mixtures of articles with carriers. (a) For each test or control article that is mixed with a carrier, tests...

21 CFR 58.113 - Mixtures of articles with carriers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Mixtures of articles with carriers. 58.113 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.113 Mixtures of articles with carriers. (a) For each test or control article that is mixed with a carrier, tests...

21 CFR 58.113 - Mixtures of articles with carriers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Mixtures of articles with carriers. 58.113 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.113 Mixtures of articles with carriers. (a) For each test or control article that is mixed with a carrier, tests...

21 CFR 58.113 - Mixtures of articles with carriers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Mixtures of articles with carriers. 58.113 Section... GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Test and Control Articles § 58.113 Mixtures of articles with carriers. (a) For each test or control article that is mixed with a carrier, tests...

40 CFR 266.107 - Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Industrial Furnaces § 266.107 Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions... streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed the levels...: terrain-adjusted effective stack height, good engineering practice stack height, terrain type, land use...

40 CFR 266.107 - Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Industrial Furnaces § 266.107 Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions... streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed the levels...: terrain-adjusted effective stack height, good engineering practice stack height, terrain type, land use...

40 CFR 266.107 - Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Industrial Furnaces § 266.107 Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions... streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed the levels...: terrain-adjusted effective stack height, good engineering practice stack height, terrain type, land use...

40 CFR 266.107 - Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Industrial Furnaces § 266.107 Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions... streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed the levels...: terrain-adjusted effective stack height, good engineering practice stack height, terrain type, land use...

40 CFR 266.107 - Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Industrial Furnaces § 266.107 Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions... streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed the levels...: terrain-adjusted effective stack height, good engineering practice stack height, terrain type, land use...

Cross-Sectional Survey on the Dengue Knowledge, Attitudes and Preventive Practices Among Students and Staff of a Public University in Malaysia.

PubMed

Lugova, H; Wallis, S

2017-04-01

Behavioural impact programmes are especially effective for dengue control and prevention. Universities are key settings for health promotion, so understanding factors that influence the practice of dengue prevention within a university community becomes important. This study aimed to examine the factors affecting dengue knowledge, attitude and preventive practices amongst students and staff of a public university. A cross-sectional survey study was conducted in Kuala Lumpur, Malaysia. A total of 372 students and staff of the NDUM were recruited by stratified sampling method. Data were collected via self-administered pre-tested structured questionnaires covering socio-demography and dengue KAP. Data were analysed descriptively. For bivariate analysis, Chi square test was applied. To explore the factors independently associated with the practice of dengue prevention, a logistic regression model was introduced. Overall, the participants had moderate dengue-related knowledge, good attitudes and good preventive practices. The majority had misconceptions about mosquito biting habits (83.8 %), seasonality of dengue epidemics (73.2 %), and mosquito breeding sites (70.3 %). Staff were more likely to have good dengue-related knowledge (p < 0.001) and attitudes (p = 0.008) than students. There was statistically significant positive association between the level of dengue knowledge and monthly average household income (p = 0.008), age (p < 0.001) and education (p < 0.001). Having good attitudes towards dengue was associated with being a non-Malay (p = 0.034), having higher monthly average household income (p = 0.047) and tertiary education (p < 0.001). In regression analysis, only dengue knowledge and dengue attitudes were significantly and positively associated with practice of dengue prevention. Dengue preventive strategies amongst university students and staff should focus on maintaining good dengue-related preventive practices. Educational campaigns should mainly target students, young staff members, and those with lower level of education and income.

Blood glucose control and quality of health care in non-insulin-treated patients with Type 2 diabetes in Spain: a retrospective and cross-sectional observational study

PubMed Central

Rodríguez, A; Calle, A; Vázquez, L; Chacón, F; Polavieja, P; Reviriego, J

2011-01-01

Aims To assess blood glucose control and quality of health care provided to non-insulin-treated patients with Type 2 diabetes mellitus in routine clinical practice in Spain. Methods In this observational, retrospective, cross-sectional study, patients were grouped as either having good or suboptimal blood glucose control according to International Diabetes Federation or American Diabetes Association HbA1c goals. Clinical and socio-demographic data and compliance with the main standard level of care recommendations of the International Diabetes Federation were recorded during a routine visit. Correlates of glucose control were analysed by logistic regression. Results Many patients were grouped as having suboptimal control under International Diabetes Federation (61.9%) or American Diabetes Association (45.0%) criteria. The mean number of accomplished International Diabetes Federation recommendations (7.3 out of 11) was higher for endocrinologists (than for internists or primary care physicians), and significantly more patients under their care were in the good glucose control group (than with primary care physicians). More recommendations were associated with blood glucose control using International Diabetes Federation than American Diabetes Association criteria, demanding higher quality of health care for achieving stricter goals. Some recommendations were poorly observed, particularly those concerning patients’ education on diabetes, the prompt prescription of effective treatments and monitoring of complications. Diabetes complications were associated with being in the suboptimal control group. Patients’ education on diabetes and HbA1c monitoring were associated with being in the good control group. Conclusions These results demonstrate the need for improvement in the management of patients with non-insulin-treated Type 2 diabetes in actual clinical practice in Spain. Such improvement would entail a stricter adherence to International Diabetes Federation recommendations. PMID:21294772

Small business, cash budgets and general practice.

PubMed

Jackson, A R

1991-01-01

In practice management, general practice falls into the category of small business with all its attendant generic problems. Disciplined planning and good financial management are not often seen in small business. These are required if general practitioners are to continue (or return to) the provision of high quality medical services. An effective budget process, especially cash-flow budgeting, is the key to successful planning and financial management. Budgeting will bring Control, Co-ordination, and Credibility to your practice. It will enable you to set goals and to achieve them.

A Practical Approach to Cultural Insight

DTIC Science & Technology

2010-09-01

particular culture: good if the unit ends up deployed where that culture resides, but not so good when the unit goes other places . The culture in one...how does it work ? ● Homogeneous Groups—Heterogeneous Groups. Are the people in a group more alike or more different? ● Rights for minorities. How...societies, the families are very private affairs rarely glimpsed by outsiders (and then only in tightly controlled circumstances). Other places

Quality assurance of herbal raw materials in supply chain: challenges and opportunities.

PubMed

Govindaraghavan, Suresh

2008-01-01

The herbal medicine industry is presently adopting modern scientific tools to substantiate the guarantee of efficacy that, in the past, rested only on anecdotal evidence derived from traditional knowledge systems. This is particularly true for the processes of identification of herbal raw materials adopting modern tools for phytochemical fingerprinting. The successful adaptation of available technologies and practices depends on an understanding of the phytochemical complexity and variability innate in biological material. It challenges the "mainstream medicinal mindset" that "tend(s) to reject …. therapies for which mechanisms of action do not fit within Newtonian, biochemical orientation" (Dumoff, 2003). The herbal medicinal industry is independently evolving its own rigid quality assurance and control systems using Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) guidelines, but it faces unique difficulties. These include lack of Good Agricultural and Collection Practice (GACP), lack of transparency in the raw material supply chain so as to preclude the use of unsafe practices, problems in the authentication of herbal raw materials, and a general lack of understanding of the need to reduce phytochemical variability in these materials. This paper explores these difficulties and outlines strategies to overcome them, but these strategies will require coordinated international government regulations to be fully effective.

Meta-analysis of food safety training on hand hygiene knowledge and attitudes among food handlers.

PubMed

Soon, Jan Mei; Baines, Richard; Seaman, Phillip

2012-04-01

Research has shown that traditional food safety training programs and strategies to promote hand hygiene increases knowledge of the subject. However, very few studies have been conducted to evaluate the impact of food safety training on food handlers' attitudes about good hand hygiene practices. The objective of this meta-analytical study was to assess the extent to which food safety training or intervention strategies increased knowledge of and attitudes about hand hygiene. A systematic review of food safety training articles was conducted. Additional studies were identified from abstracts from food safety conferences and food science education conferences. Search terms included combinations of "food safety," "food hygiene," "training," "education," "hand washing," "hand hygiene," "knowledge," "attitudes," "practices," "behavior," and "food handlers." Only before- and after-training approaches and cohort studies with training (intervention group) and without training (control group) in hand hygiene knowledge and including attitudes in food handlers were evaluated. All pooled analyses were based on a random effects model. Meta-analysis values for nine food safety training and intervention studies on hand hygiene knowledge among food handlers were significantly higher than those of the control (without training), with an effect size (Hedges' g) of 1.284 (95% confidence interval [CI] ∼ 0.830 to 1.738). Meta-analysis of five food safety training and intervention studies in which hand hygiene attitudes and self-reported practices were monitored produced a summary effect size of 0.683 (95% CI ∼ 0.523 to 0.843). Food safety training increased knowledge and improved attitudes about hand hygiene practices. Refresher training and long-term reinforcement of good food handling behaviors may also be beneficial for sustaining good hand washing practices.

21 CFR 110.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria and...

76 FR 47593 - Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-05

...] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 210.1 - Status of current good manufacturing practice regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice regulations...

21 CFR 226.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115, inclusive...

Influence of good manufacturing practices on the shelf life of refrigerated fillets of tilapia (Oreochromis niloticus) packed in modified atmosphere and gamma-irradiated

PubMed Central

Monteiro, Maria Lúcia Guerra; Mársico, Eliane Teixeira; Mano, Sérgio Borges; Teixeira, Claudia Emília; da Cruz Silva Canto, Anna Carolina Vilhena; de Carvalho Vital, Helio; Conte-Júnior, Carlos Adam

2013-01-01

This study evaluated the influence of good manufacturing practices (GMP) on the shelf life of refrigerated fillets of Nile tilapia (Oreochromis niloticus) packed in modified atmosphere packaging (MAP) and irradiated. In a first series of experiments, 120 tilapia fillets kept under controlled sanitary conditions were purchased from a fish market managed by a cooperative. A second lot totaling 200 tilapia fillets was obtained under controlled storage conditions from a pilot plant. The combined effects of MAP (40% CO2 and 60% N2) and irradiation (1.5 kGy) were investigated by monitoring physical and chemical (total volatile bases and pH), bacteriological (aerobic heterotrophic mesophilic and psychrophilic bacteria) and sensory (acceptance test) changes in the samples. The quality of samples decreased with storage time regardless of the treatment, remaining higher in fillets produced in the pilot plant in comparison with the commercially produced fillets. The observed shelf life of nonirradiated commercially produced fillets was only 3 days, compared to 8 days for those produced in the pilot plant, probably due to GMP in the latter. It was concluded that, even with a combination of proven conservation methods for meats, the adoption of good manufacturing practices still remains essential before, during, and after the filleting process in order to ensure the effectiveness of the entire treatment. PMID:24804034

40 CFR 180.1114 - Pseudomonas fluorescens A506, Pseudomonas fluorescens 1629RS, and Pseudomonas syringae 742RS...

Code of Federal Regulations, 2013 CFR

2013-07-01

... biological control agent to growing agricultural crops in accordance with good agricultural practices. [57 FR... 742RS; exemptions from the requirement of a tolerance. The biological pesticides Pseudomonas fluorescens...

40 CFR 180.1114 - Pseudomonas fluorescens A506, Pseudomonas fluorescens 1629RS, and Pseudomonas syringae 742RS...

Code of Federal Regulations, 2014 CFR

2014-07-01

... biological control agent to growing agricultural crops in accordance with good agricultural practices. [57 FR... 742RS; exemptions from the requirement of a tolerance. The biological pesticides Pseudomonas fluorescens...

40 CFR 180.1114 - Pseudomonas fluorescens A506, Pseudomonas fluorescens 1629RS, and Pseudomonas syringae 742RS...

Code of Federal Regulations, 2012 CFR

2012-07-01

... biological control agent to growing agricultural crops in accordance with good agricultural practices. [57 FR... 742RS; exemptions from the requirement of a tolerance. The biological pesticides Pseudomonas fluorescens...

40 CFR 180.1114 - Pseudomonas fluorescens A506, Pseudomonas fluorescens 1629RS, and Pseudomonas syringae 742RS...

Code of Federal Regulations, 2010 CFR

2010-07-01

... biological control agent to growing agricultural crops in accordance with good agricultural practices. [57 FR... 742RS; exemptions from the requirement of a tolerance. The biological pesticides Pseudomonas fluorescens...

40 CFR 180.1114 - Pseudomonas fluorescens A506, Pseudomonas fluorescens 1629RS, and Pseudomonas syringae 742RS...

Code of Federal Regulations, 2011 CFR

2011-07-01

... biological control agent to growing agricultural crops in accordance with good agricultural practices. [57 FR... 742RS; exemptions from the requirement of a tolerance. The biological pesticides Pseudomonas fluorescens...

A quantitative analysis of attitudes and behaviours concerning sustainable parasite control practices from Scottish sheep farmers.

PubMed

Jack, Corin; Hotchkiss, Emily; Sargison, Neil D; Toma, Luiza; Milne, Catherine; Bartley, David J

2017-04-01

Nematode control in sheep, by strategic use of anthelmintics, is threatened by the emergence of roundworms populations that are resistant to one or more of the currently available drugs. In response to growing concerns of Anthelmintic Resistance (AR) development in UK sheep flocks, the Sustainable Control of Parasites in Sheep (SCOPS) initiative was set up in 2003 in order to promote practical guidelines for producers and advisors. To facilitate the uptake of 'best practice' approaches to nematode management, a comprehensive understanding of the various factors influencing sheep farmers' adoption of the SCOPS principles is required. A telephone survey of 400 Scottish sheep farmers was conducted to elicit attitudes regarding roundworm control, AR and 'best practice' recommendations. A quantitative statistical analysis approach using structural equation modelling was chosen to test the relationships between both observed and latent variables relating to general roundworm control beliefs. A model framework was developed to test the influence of socio-psychological factors on the uptake of sustainable (SCOPS) and known unsustainable (AR selective) roundworm control practices. The analysis identified eleven factors with significant influences on the adoption of SCOPS recommended practices and AR selective practices. Two models established a good fit with the observed data with each model explaining 54% and 47% of the variance in SCOPS and AR selective behaviours, respectively. The key influences toward the adoption of best practice parasite management, as well as demonstrating negative influences on employing AR selective practices were farmer's base line understanding about roundworm control and confirmation about lack of anthelmintic efficacy in a flock. The findings suggest that improving farmers' acceptance and uptake of diagnostic testing and improving underlying knowledge and awareness about nematode control may influence adoption of best practice behaviour. Copyright © 2017 Elsevier B.V. All rights reserved.

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) General Provisions § 212.2 What is current good manufacturing practice for...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part set...

Caught between the global economy and local bureaucracy: the barriers to good waste management practice in South Africa.

PubMed

Godfrey, Linda; Scott, Dianne; Trois, Cristina

2013-03-01

Empirical research shows that good waste management practice in South Africa is not always under the volitional control of those tasked with its implementation. While intention to act may exist, external factors, within the distal and proximal context, create barriers to waste behaviour. In addition, these barriers differ for respondents in municipalities, private industry and private waste companies. The main barriers to implementing good waste management practice experienced by respondents in municipalities included insufficient funding for waste management and resultant lack of resources; insufficient waste knowledge; political interference in decision-making; a slow decision-making process; lack of perceived authority to act by waste staff; and a low priority afforded to waste. Barriers experienced by respondents in private industry included insufficient funding for waste and the resultant lack of resources; insufficient waste knowledge; and government bureaucracy. Whereas, barriers experienced in private waste companies included increasing costs; government bureaucracy; global markets; and availability of waste for recycling. The results suggest that respondents in public and private waste organizations are subject to different structural forces that shape, enable and constrain waste behaviour.

21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false How must I control the components I use to produce PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD... GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) Control of...

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

40 CFR 792.29 - Personnel.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Personnel. 792.29 Section 792.29 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.29 Personnel. (a) Each individual...

78 FR 8583 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... that resulted in exceedances of the national ambient air quality standard for lead, failed to use good air pollution control practices for minimizing lead emissions, and caused a common law nuisance at its...

[Quality control in herbal supplements].

PubMed

Oelker, Luisa

2005-01-01

Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

Drainpipe network management information system design based on GIS and SCADA technique

NASA Astrophysics Data System (ADS)

Gu, Ze-Yu; Zhao, De-An

2011-02-01

Achieving urban drainpipe network integration of geographical information system (GIS) and supervisory control and data acquisition (SCADA) technology is described in this paper. The system design's plans are put forward, which have realized GIS and SCADA system supplementary in the technology and strengthened the model visible analysis ability. It is verified by practical cases that the system has more practical values and a good prospect.

78 FR 3646 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-16

...The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk- based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.

Emerging Good Practices for Transforming Value Assessment: Patients' Voices, Patients' Values.

PubMed

Perfetto, Eleanor M; Harris, Jason; Mullins, C Daniel; dosReis, Susan

2018-04-01

Patient engagement is a transformative strategy for improving value assessment. US value framework developers have increased engagement activities, but more needs to be learned about how to best achieve meaningful patient engagement in value assessment. The objective was to glean good practices in patient engagement emerging from patient community experiences, to be used in value assessment. The National Health Council Value Workgroup conducted a survey and held a focus group with its member advocacy organizations to gather experiences with value framework developers and views on emerging good practices. Ten of 13 organizations completed the survey; reporting 13 interactions with four framework developers. Most rated experiences as "good" to "very good." Emerging good practices included (1) engage early; (2) engage a range of patients; (3) leverage patient-provided information, data resources, and outreach mechanisms; (4) be transparent; and (5) appreciate and accommodate resource constraints. Twelve of 13 organizations participated in the focus group, and this produced 30 emerging good practices in four areas: (1) timing; (2) methodology and data; (3) partnering; and (4) characterizing engagement. Patient engagement was limited in early development of value frameworks but has increased in the past few years. Patient groups report positive experiences that can serve as emerging good practices. These groups also reported experienced challenges in their interactions and recommended good practices to mitigate those challenges. The growing pool of patient engagement experiences can be translated into good practices to advance a patient-centered, value-driven health care ecosystem. Lessons learned from these early experiences can help establish recommend emerging good practices that can eventually result in best practices and standards in the field. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Current regulatory issues in cell and tissue therapy.

PubMed

Burger, S R

2003-01-01

Cell-based therapies have grown dramatically in power and scope in recent years. Once limited to blood and BM transplantation, these therapies now encompass tissue repair and regeneration, metabolic support, gene replacement, and immune effector functions, with established and investigational clinical applications in disorders affecting nearly every tissue and organ system. The complexity and novel applications of human cells, tissues, and cellular and tissue-based products (HCT/Ps), however, present potential risks for adverse events. The US Food and Drug Administration, responding to these concerns, has established a tiered, risk-based regulatory structure, in which more rigorous controls and safeguards are required for products thought to pose increased risk. The proposed good tissue practices (GTP) rule and existing good manufacturing practices (GMP) requirements form the principal elements of this regulatory framework. The proposed GTPs are intended to prevent HCT/P contamination with infectious disease agents, and to ensure that these cells and tissues maintain their integrity and function. GMPs focus on production of safe, pure, and potent products, and entail a higher level of process control and product characterization. All HCT/Ps will be required to comply with GTPs. HCT/Ps considered to present greater risks of adverse events, however, will be subject to both GTPs and GMPs, and must obtain premarket approval using the Investigational New Drug (IND) mechanism established for biologics. Although these requirements will present significant challenges for clinician- investigators and laboratories producing HCT/Ps, the regulations fundamentally support good clinical care by increasing safety and control, and enable good science by improving the quality and reliability of data.

Good practices in Local Government - A first overview of Portuguese reality

NASA Astrophysics Data System (ADS)

Carvalhosa, P.; Portela, F.; Machado, J.; Santos, M. F.; Abelha, A.

2017-03-01

Good practices in eGov are being increasingly used by Local Governments being that it is considered by them as an advantage. The main goal is providing to the town hall a differentiation point and approximate their services to the citizens. For this, it is necessary to define and apply innovative strategies in order to increase the use of services by the citizens. This paper is framed in a research work and it presents a first overview of the existing good practices in eGov, taking in consideration the Portuguese’s reality. The good practices identified were distinguished with many awards and with a positive response from the target audience. The use of digital marketing strategies aims to increase their membership and coming closer the municipalities of its citizens through the dissemination of the good practices. At this moment the data collected are almost exclusively of good practice in Portugal, however some international practices were also identified. As a result of this study the community has a list of good practices that can be applied in their municipalities.

Are you good enough for your patients? The European certification model in laparoscopic surgery

PubMed Central

Campo, R.; Molinas, C.R.; De Wilde, R.L.; Brolmann, H.; Brucker, S.; Mencaglia, L.; Odonovan, P.; Wallwiener, D.; Wattiez, A.

2012-01-01

Quality control, training and education in gynaecological surgery are challenged and urgent measures are emerging. The implementation of a structured and validated program for training and quality control seems the most urgent measurement to be taken. The European Academy of Gynaecological Surgery has made a first attempt to do so. Through a practical and theoretical tests system, the skills of an individual surgeon is measured and the conditions to enter the different level of expertise are clearly defined. This certification system based on the best possible level of scientific evidence provides a first practical tool, universally implementable for a decent quality control and structured training program in Gynaecological laparoscopic surgery. PMID:24753896

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Laboratory operation areas. 792.49 Section 792.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas...

40 CFR 792.61 - Equipment design.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Equipment design. 792.61 Section 792.61 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Equipment § 792.61 Equipment design. Equipment used in the...

40 CFR 792.83 - Reagents and solutions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Reagents and solutions. 792.83 Section 792.83 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.83 Reagents and...

40 CFR 792.41 - General.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true General. 792.41 Section 792.41 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.41 General. Each testing facility shall be of...

Securing the Adoption of Good Practice in Scotland's Colleges. A Report by HM Inspectors of Education for the Scottish Funding Council

ERIC Educational Resources Information Center

Her Majesty's Inspectorate of Education, 2006

2006-01-01

The purpose of this report is to describe the main mechanisms currently in use in Scotland's colleges to ensure that the adoption of good practice actually happens. It investigates how colleges identify and promote good practice in their own institutions; how they develop strategies and processes to ensure good practice is shared, adopted and…

Communication and contraceptive practices in adolescent couples.

PubMed

Polit-O'Hara, D; Kahn, J R

1985-01-01

This study presents a descriptive analysis of the content, frequency, and timing of couple communication regarding birth control among stable, sexually active adolescent couples, and the effect of communication on actual contraceptive practices. The sample consisted of 83 couples in which the female partner was 15-18 years old. All couples had been sexually active at least two months prior to the interview. The majority of couples had discussed birth control on at least one occasion, but discussions prior to first intercourse were atypical. Couples with good communication patterns were more likely to practice effective contraception. One-fourth of the respondents felt that contraception had not been adequately discussed, and these individuals were found to be most at risk to an unintended pregnancy.

Experimental investigation of shaping disturbance observer design for motion control of precision mechatronic stages with resonances

NASA Astrophysics Data System (ADS)

Yang, Jin; Hu, Chuxiong; Zhu, Yu; Wang, Ze; Zhang, Ming

2017-08-01

In this paper, shaping disturbance observer (SDOB) is investigated for precision mechatronic stages with middle-frequency zero/pole type resonance to achieve good motion control performance in practical manufacturing situations. Compared with traditional standard disturbance observer (DOB), in SDOB a pole-zero cancellation based shaping filter is cascaded to the mechatronic stage plant to meet the challenge of motion control performance deterioration caused by actual resonance. Noting that pole-zero cancellation is inevitably imperfect and the controller may even consequently become unstable in practice, frequency domain stability analysis is conducted to find out how each parameter of the shaping filter affects the control stability. Moreover, the robust design criterion of the shaping filter, and the design procedure of SDOB, are both proposed to guide the actual design and facilitate practical implementation. The SDOB with the proposed design criterion is applied to a linear motor driven stage and a voice motor driven stage, respectively. Experimental results consistently validate the effectiveness nature of the proposed SDOB scheme in practical mechatronics motion applications. The proposed SDOB design actually could be an effective unit in the controller design for motion stages of mechanical manufacture equipments.

Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

PubMed

Brodish, D L

1998-01-01

The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

[Good practice in occupational health services: prophylactic care and occupational activation of people with disabilities due to respiratory diseases].

PubMed

Wiszniewska, Marta; Tymoszuk, Diana; Lipińska-Ojrzanowska, Agnieszka; Wagrowska-Koski, Ewa; Walusiak-Skorupa, Jolanta

2013-01-01

Respiratory diseases are a cause of long-term sickness absence, and even of partial or complete inability to work. This paper presents the first in Poland description of principles of good practice in occupational health service provided for people with respiratory diseases. The issues concerning the certification of the ability to work in this group of patients are discussed. The key-principles of preventive care of workers with obstructive and interstitial lung diseases with particular attention paid to the control of major risk factors are also presented. The importance of possible contraindications for job performance by workers affected by these diseases, as well as the responsibilities of occupational health physicians were highlighted. M

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient... levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this...

Keeping waived tests simple.

PubMed

2004-01-01

Laboratories performing waived testing must follow the manufacturer's instructions as well as good laboratory practices to ensure that test results are reliable. Four things to concentrate on to maximize the performance and reliability of waived tests are to: 1. Read and follow the information found in the package inserts. 2. Follow the manufacturer's recommendations for running quality control. 3. Train staff members to perform tests correctly. 4. Follow established policies and procedures for patient testing in the practice.

The virtuous pathologist. An ethical basis for laboratory medicine.

PubMed

Stempsey, W E

1989-06-01

The profession of pathology is a practice in the technical sense used by many philosophers. Such practices have internal goods, which, it is hoped, lead to the attainment of a certain end. The ultimate end of the practice of pathology must be the good of the patient in terms of restoring health. Key internal goods in pathology are technical competence, the proper pathologist-patient relationship, and the proper pathologist-clinician relationship. Virtues are predispositions to act so as to attain the end of the practice and further the internal goods. Technical growth in the practice of pathology must be accompanied by continued attempts to articulate the goals and internal goods of the practice. Only if pathologists are predisposed to act in accordance with proper goals will an ethical practice be assured.

[Identification of Good-Practice Projects in Promoting Physical Activity - Methods, Pitfalls and Sampled Outcomes].

PubMed

Henn, Annette; Karger, Claudia; Wöhlken, Katrin; Meier, Diana; Ungerer-Röhrich, Ulrike; Graf, Christine; Woll, Alexander

2017-03-01

The aim of this paper is to identify and show examples of good practice of public health promotion. For this, uniform quality criteria were worked out under consideration of national and international scientific literature.For the identification of examples of good practice, a comparison of different quality criteria was carried out and combined with each other in a first step. In the following step, examples of good practice were identified after a comprehensive search. The choice of the "good-practice" projects is exemplary and lays no claim to completeness.6 main quality criteria (QC) of programs promoting physical activity could be identified in the national and international context. The analysis showed altogether 10 projects which can exemplarily be classified as examples of good practice of the target groups of children and teenagers, adults, older people and people with pre-existing illnesses. These projects, however, show major differences in their (methodological) quality.The analysis reports a lack of "Good-Practice" examples. Deficits lie mainly in documentation and sustainability. Because of incomplete documentation, an assessment as a "Good-Practice" example is only possible to a limited extent; a lot of information, particularly in the evaluation, is missing. © Georg Thieme Verlag KG Stuttgart · New York.

40 CFR 792.17 - Effects of non-compliance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Effects of non-compliance. 792.17 Section 792.17 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.17 Effects of non...

40 CFR 792.15 - Inspection of a testing facility.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Inspection of a testing facility. 792.15 Section 792.15 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.15 Inspection...

40 CFR 792.43 - Test system care facilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Test system care facilities. 792.43 Section 792.43 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.43 Test system care facilities...

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false General requirements. 211.160 Section 211.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false General requirements. 211.160 Section 211.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false General requirements. 211.160 Section 211.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 225.65 - Equipment cleanout procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.65 Equipment cleanout procedures. (a) Adequate cleanout procedures for all equipment used in the manufacture... sequential production of feeds. (2) If flushing is utilized, the flush material shall be properly identified...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

21 CFR 886.1870 - Stereoscope.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle... exercises of eye muscles. (b) Classification. Class I (general controls). The AC-powered device and the... current good manufacturing practice requirements of the quality system regulation in part 820 of this...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

21 CFR 211.176 - Penicillin contamination.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Penicillin contamination. 211.176 Section 211.176 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.176...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

Outdoor Lighting Ordinances

NASA Astrophysics Data System (ADS)

Davis, S.

2004-05-01

A principal means to prevent poor exterior lighting practices is a lighting control ordinance. It is an enforceable legal restriction on specific lighting practices that are deemed unacceptable by the government body having jurisdiction. Outdoor lighting codes have proven to be effective at reducing polluting and trespassing light. A well written exterior lighting code will permit all forms of necessary illumination at reasonable intensities, but will demand shielding and other measures to prevent trespass and light pollution. A good code will also apply to all forms of outdoor lighting, including streets, highways, and exterior signs, as well as the lighting on dwellings, commercial and industrial buildings and building sites. A good code can make exceptions for special uses, provided it complies with an effective standard. The IDA Model Lighting Ordinance is a response to these requests. It is intended as an aid to communities that are seeking to take control of their outdoor lighting, to "take back the night" that is being lost to careless and excessive use of night lighting.

Safety and quality of food contact materials. Part 1: evaluation of analytical strategies to introduce migration testing into good manufacturing practice.

PubMed

Feigenbaum, A; Scholler, D; Bouquant, J; Brigot, G; Ferrier, D; Franzl, R; Lillemarktt, L; Riquet, A M; Petersen, J H; van Lierop, B; Yagoubi, N

2002-02-01

The results of a research project (EU AIR Research Programme CT94-1025) aimed to introduce control of migration into good manufacturing practice and into enforcement work are reported. Representative polymer classes were defined on the basis of chemical structure, technological function, migration behaviour and market share. These classes were characterized by analytical methods. Analytical techniques were investigated for identification of potential migrants. High-temperature gas chromatography was shown to be a powerful method and 1H-magnetic resonance provided a convenient fingerprint of plastic materials. Volatile compounds were characterized by headspace techniques, where it was shown to be essential to differentiate volatile compounds desorbed from those generated during the thermal desorption itself. For metal trace analysis, microwave mineralization followed by atomic absorption was employed. These different techniques were introduced into a systematic testing scheme that is envisaged as being suitable both for industrial control and for enforcement laboratories. Guidelines will be proposed in the second part of this paper.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2003-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

Teleworking: Guidelines for Good Practice. IES Report 329.

ERIC Educational Resources Information Center

Huws, Ursula; And Others

Because teleworking presents major new challenges to human resource managers, trade unions, and others involved in the development of good employment practices, this book provides practical guidelines for good practice in regard to teleworkers that recognize that teleworking is not a single category, but covers at least five distinct groups with…

The Impact of Peer Mentoring on Levels of Student Wellbeing, Integration and Retention: A Controlled Comparative Evaluation of Residential Students in UK Higher Education

ERIC Educational Resources Information Center

Collings, R.; Swanson, V.; Watkins, R.

2014-01-01

Peer mentoring is becoming increasingly popular in UK higher education, however, there remains little good quality, theoretically driven and evaluative research. The current study aims to bridge the gap between theory, practice and evaluation by providing a controlled evaluation of a peer mentoring scheme within UK universities. 109 first year…

Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

PubMed

Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

2015-12-01

The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by institutional structures for the clinical practice of EEG NF. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

Code of Federal Regulations, 2010 CFR

2010-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

Protection of people and environment from radiation risk through good regulatory practice

NASA Astrophysics Data System (ADS)

Jais, Azlina Mohammad; Hassan, Najwa

2017-01-01

The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be considered by nuclear regulatory authority and the necessary criteria of an "ideal" how nuclear regulatory authority should implement the "good regulatory practice" approach.

[Design of a miniaturized blood temperature-varying system based on computer distributed control].

PubMed

Xu, Qiang; Zhou, Zhaoying; Peng, Jiegang; Zhu, Junhua

2007-10-01

Blood temperature-varying has been widely applied in clinical practice such as extracorporeal circulation for whole-body perfusion hyperthermia (WBPH), body rewarming and blood temperature-varying in organ transplantation. This paper reports a novel DCS (Computer distributed control)-based blood temperature-varying system which includes therapy management function and whose hardware and software can be extended easily. Simulation results illustrate that this system provides precise temperature control with good performance in various operation conditions.

40 CFR 792.10 - Applicability to studies performed under grants and contracts.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Applicability to studies performed under grants and contracts. 792.10 Section 792.10 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS General...

40 CFR 792.51 - Specimen and data storage facilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Specimen and data storage facilities. 792.51 Section 792.51 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.51 Specimen and data...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.134 - Drug product inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 111.16 - What are the requirements under this subpart C for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... follow written procedures for cleaning the physical plant and for pest control. ...

21 CFR 111.16 - What are the requirements under this subpart C for written procedures?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... follow written procedures for cleaning the physical plant and for pest control. ...

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE..., body weight range, sex, source of supply, species, strain, substrain, and age of the test system. (5... kilogram of body weight or other appropriate units, of the test or control article to be administered and...

21 CFR 110.37 - Sanitary facilities and controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING... from the plant. (3) Avoid constituting a source of contamination to food, water supplies, equipment, or... against contamination of food. (f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed...

40 CFR 792.51 - Specimen and data storage facilities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 33 2013-07-01 2013-07-01 false Specimen and data storage facilities..., for the storage and retrieval of all raw data and specimens from completed studies. ... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.51 Specimen and data...

40 CFR 792.51 - Specimen and data storage facilities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 32 2014-07-01 2014-07-01 false Specimen and data storage facilities..., for the storage and retrieval of all raw data and specimens from completed studies. ... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.51 Specimen and data...

40 CFR 792.51 - Specimen and data storage facilities.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Specimen and data storage facilities..., for the storage and retrieval of all raw data and specimens from completed studies. ... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.51 Specimen and data...

40 CFR 792.51 - Specimen and data storage facilities.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 33 2012-07-01 2012-07-01 false Specimen and data storage facilities..., for the storage and retrieval of all raw data and specimens from completed studies. ... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.51 Specimen and data...

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Laboratory operation areas. 792.49... CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas. Separate laboratory space and other space shall be provided, as needed, for the performance of the routine...

40 CFR 792.12 - Statement of compliance or non-compliance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Statement of compliance or non-compliance. 792.12 Section 792.12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.12 Statement...

Top 10 metrics for life science software good practices.

PubMed

Artaza, Haydee; Chue Hong, Neil; Corpas, Manuel; Corpuz, Angel; Hooft, Rob; Jimenez, Rafael C; Leskošek, Brane; Olivier, Brett G; Stourac, Jan; Svobodová Vařeková, Radka; Van Parys, Thomas; Vaughan, Daniel

2016-01-01

Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here.

Top 10 metrics for life science software good practices

PubMed Central

2016-01-01

Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here. PMID:27635232

Improving general practitioner clinical records with a quality assurance minimal intervention.

PubMed Central

Del Mar, C B; Lowe, J B; Adkins, P; Arnold, E; Baade, P

1998-01-01

BACKGROUND: Although good medical records have been associated with good care, there is considerable room for their improvement in general practice. AIM: To improve the quality of general practice medical records at minimal cost. METHOD: A total of 150 randomly sampled general practitioners (GPs) in suburban Brisbane, Australia, were randomized in a controlled trial to receive or not receive an intervention. The intervention consisted of 6 to 12 one-hour monthly meetings when the pairs of GPs assessed samples of each other's medical records using a 12-item instrument. This was developed previously by a process of consensus of general practice teachers. Mean scores of 10 medical records selected at random from before the intervention started and one year later were compared. RESULTS: After the intervention, the increase in the total score (for which the maximum possible was 18) for the intervention GPs (from a baseline of 11.5 to 12.3) was not significantly greater than for the controls (from 11.4 to 11.7). Legibility and being able to determine the doctor's assessment of the consultation were significantly improved. The post-intervention increase of 1.06 (9.3%) of the total scores of the 47% of intervention GPs who complied with the intervention was significantly greater than that for the controls. CONCLUSION: The quality assurance activity improved some components of the quality of GPs' clinical records. However, the improvement was small, and the search for activities for Australian GPs that demonstrate an improvement in the quality of their practice must continue. Images p1311-a PMID:9747547

[Social marketing: applying commercial strategies to the prevention of nosocomial infections].

PubMed

Sax, Hugo; Longtin, Yves; Alvarez-Ceyssat, Raymonde; Bonfillon, Chantal; Cavallero, Sabrina; Dayer, Pierre; Ginet, Claude; Herrault, Pascale

2009-04-01

Although a large proportion of healthcare-associated infections are avoidable, healthcare workers do not always practice evidence-based preventive strategies. Marketing technologies might help to improve patient safety. This article presents the basic principles of marketing and its potential use to promote good infection control practices. The marketing mix (Product, Price, Place, and Promotion) should be taken into account to induce behaviour change. By placing the emphasis on the perceived "profits" for healthcare workers the approach might lose its moral aspect and gain in effectiveness. VigiGerme, a non-commercial registered trademark, applies social marketing techniques to infection control and prevention.

Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Review and Applicability for Chemical Security Enhancements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Iveson, Steven W.

Global chemical security has been enhanced through the determined use and integration of both voluntary and legislated standards. Many popular standards contain components that specifically detail requirements for the security of materials, facilities and other vital assets. In this document we examine the roll of quality management standards and how they affect the security culture within the institutions that adopt these standards in order to conduct business within the international market place. Good manufacturing practices and good laboratory practices are two of a number of quality management systems that have been adopted as law in many nations. These standards aremore » designed to protect the quality of drugs, medicines, foods and analytical test results in order to provide the world-wide consumer with safe and affective products for consumption. These standards provide no established security protocols and yet manage to increase the security of chemicals, materials, facilities and the supply chain via the effective and complete control over the manufacturing, the global supply chains and testing processes. We discuss the means through which these systems enhance security and how nations can further improve these systems with additional regulations that deal specifically with security in the realm of these management systems. We conclude with a discussion of new technologies that may cause disruption within the industries covered by these standards and how these issues might be addressed in order to maintain or increase the level of security within the industries and nations that have adopted these standards.« less

WA40 The good neighbour partnership: why do we need it? who is going to do it? how on earth are we going to evaluate it?

PubMed

McLoughlin, Kathleen; Rhatigan, Jim; McGilloway, Sinead; Callinan, Joanne; Wright, Marie; Kellehear, Allan; Lucey, Michael; Conroy, Marian; Twomey, Feargal; Kumar, Suresh; Herrera-Mollina, Emillio; Furlong, Mairead; Watson, Max; Currow, David; Bailey, Christopher

2015-04-01

: This one-hour symposium considers Milford Care Centre's Compassionate Communities Good Neighbour Partnership and it's evaluation by an international team, led by Maynooth University and funded by the All Ireland Institute of Hospice and Palliative Care, The Irish Cancer Society, The Irish Hospice Foundation and Milford Care Centre. The symposium will be divided into three sections: 1. The Good Neighbour Partnership: Why do we need it? In this section we will describe the findings from a recent scoping study to determine the social and practical needs of community dwelling adults (and their families) living with advanced life limiting illness at home. We will consider the rationale for specialist palliative care services, working with community groups, to lead the development of a volunteer-based social model of care to address unmet need. 2. The Good Neighbour Partnership: How do we recruit and train volunteers? We will share our process and experience of recruiting and training 15 Compassionate Communities Volunteers to assess unmet social and practical need, and to mobile the person's circle of community to meet those needs. An understanding of the motivating factors of volunteers will be shared. 3. The Good Neighbour Partnership: How on earth are we going to evaluate it? Here we describe the INSPIRE study - Investigating Social and Practical Supports at the End of life. An exploratory delayed intervention randomised controlled trial (framed by the MRC Framework for Complex Interventions) to assess the feasibility, acceptability and potential effectiveness of the Good Neighbour Partnership. © 2015, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Reputation, relationships, risk communication, and the role of trust in the prevention and control of communicable disease: a review.

PubMed

Cairns, Georgina; de Andrade, Marisa; MacDonald, Laura

2013-01-01

Population-level compliance with health protective behavioral advice to prevent and control communicable disease is essential to optimal effectiveness. Multiple factors affect perceptions of trustworthiness, and trust in advice providers is a significant predeterminant of compliance. While competency in assessment and management of communicable disease risks is critical, communications competency may be equally important. Organizational reputation, quality of stakeholder relationships and risk information provision strategies are trust moderating factors, whose impact is strongly influenced by the content, timing and coordination of communications. This article synthesizes the findings of 2 literature reviews on trust moderating communications and communicable disease prevention and control. We find a substantial evidence base on risk communication, but limited research on other trust building communications. We note that awareness of good practice historically has been limited although interest and the availability of supporting resources is growing. Good practice and policy elements are identified: recognition that crisis and risk communications require different strategies; preemptive dialogue and planning; evidence-based approaches to media relations and messaging; and building credibility for information sources. Priority areas for future research include process and cost-effectiveness evaluation and the development of frameworks that integrate communication and biomedical disease control and prevention functions, conceptually and at scale.

Good practices in transportation evacuation preparedness and response : results of the FHWA workshop series.

DOT National Transportation Integrated Search

2009-08-01

This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

Good practices in transportation evacuation preparedness and response : results of the FHWA Workshop Series

DOT National Transportation Integrated Search

2009-08-01

This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 111.23 - Under this subpart C, what records must you make and keep?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... of the written procedures for cleaning the physical plant and for pest control. (c) You must make and...

21 CFR 111.23 - Under this subpart C, what records must you make and keep?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... of the written procedures for cleaning the physical plant and for pest control. (c) You must make and...

Citizen's Guide to Pesticides.

ERIC Educational Resources Information Center

Environmental Protection Agency, Washington, DC. Office of Pesticide Programs.

This guide provides suggestions on pest control and safety rules for pesticide use at home. Pest prevention may be possible by modification of pest habitat: removal of food and water sources, removal or destruction of pest shelter and breeding sites, and good horticultural practices that reduce plant stress. Nonchemical alternatives to pesticides…

75 FR 72827 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... Manufacturing Practice Regulations for Type A Medicated Articles AGENCY: Food and Drug Administration, HHS... on the recordkeeping requirements for manufacturers of type A medicated articles. DATES: Submit... Type A Medicated Articles--21 CFR Part 226 (OMB Control Number 0910-0154)--Extension Under section 501...

Add Yoga to Your Singing Warm-Ups

ERIC Educational Resources Information Center

Kuhn, Ivana Pinho

2006-01-01

Yoga has much to contribute to singing. The main physical disciplines of yoga are strength, flexibility, alignment, body awareness through breath control, and concentration. These basics also constitute the core of good singing. With instruction incorporated into the regular warm-up, one can introduce beginning yoga ideas into choir practice. Yoga…

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

40 CFR 792.10 - Applicability to studies performed under grants and contracts.

Code of Federal Regulations, 2011 CFR

2011-07-01

... AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS General... person utilizes the services of a consulting laboratory, contractor, or grantee to perform all or a part of a study to which this part applies, it shall notify the consulting laboratory, contractor, or...

Evaluation of the DCA Vantage analyzer for HbA 1c assay.

PubMed

Szymezak, Jean; Leroy, Nathalie; Lavalard, Emmanuelle; Gillery, Philippe

2008-01-01

Measurement of HbA 1c is key in monitoring diabetic patients in both laboratories and clinical units, where HbA 1c results are used as part of patient education. We have evaluated the DCA Vantage, a new device for immunological assay of HbA 1c. HbA 1c results obtained were evaluated in terms of precision, linearity, specificity and practicability, and were compared with results obtained by a Variant II HPLC method. The method exhibited intra- and inter-assay coefficients of variation lower than 2.6% and 4.0%, respectively, and good correlation with the comparison HPLC method (r2=0.9776). No interference was noted in the presence of labile HbA 1c or carbamylated hemoglobin. The new device exhibited improved practicability characteristics and allowed better sample identification, better management of quality control routines and greater connectivity possibilities compared to the previous DCA 2000 analyzer. This new analyzer exhibited analytical and practical characteristics very suitable for HbA 1c assay for laboratory or point-of-care use according to good laboratory practice.

Knowledge, attitude and practice regarding dengue fever among the healthy population of highland and lowland communities in central Nepal.

PubMed

Dhimal, Meghnath; Aryal, Krishna Kumar; Dhimal, Mandira Lamichhane; Gautam, Ishan; Singh, Shanker Pratap; Bhusal, Chop Lal; Kuch, Ulrich

2014-01-01

Dengue fever (DF) is the most rapidly spreading mosquito-borne viral disease in the world. In this decade it has expanded to new countries and from urban to rural areas. Nepal was regarded DF free until 2004. Since then dengue virus (DENV) has rapidly expanded its range even in mountain regions of Nepal, and major outbreaks occurred in 2006 and 2010. However, no data on the local knowledge, attitude and practice (KAP) of DF in Nepal exist although such information is required for prevention and control measures. We conducted a community based cross-sectional survey in five districts of central Nepal between September 2011 and February 2012. We collected information on the socio-demographic characteristics of the participants and their knowledge, attitude and practice regarding DF using a structured questionnaire. We then statistically compared highland and lowland communities to identify possible causes of observed differences. Out of 589 individuals interviewed, 77% had heard of DF. Only 12% of the sample had good knowledge of DF. Those living in the lowlands were five times more likely to possess good knowledge than highlanders (P<0.001). Despite low knowledge levels, 83% of the people had good attitude and 37% reported good practice. We found a significantly positive correlation among knowledge, attitude and practice (P<0.001). Among the socio-demographic variables, the education level of the participants was an independent predictor of practice level (P<0.05), and education level and interaction between the sex and age group of the participants were independent predictors of attitude level (P<0.05). Despite the rapid expansion of DENV in Nepal, the knowledge of people about DF was very low. Therefore, massive awareness programmes are urgently required to protect the health of people from DF and to limit its further spread in this country.

Knowledge, Attitude and Practice Regarding Dengue Fever among the Healthy Population of Highland and Lowland Communities in Central Nepal

PubMed Central

Dhimal, Meghnath; Aryal, Krishna Kumar; Dhimal, Mandira Lamichhane; Gautam, Ishan; Singh, Shanker Pratap; Bhusal, Chop Lal; Kuch, Ulrich

2014-01-01

Background Dengue fever (DF) is the most rapidly spreading mosquito-borne viral disease in the world. In this decade it has expanded to new countries and from urban to rural areas. Nepal was regarded DF free until 2004. Since then dengue virus (DENV) has rapidly expanded its range even in mountain regions of Nepal, and major outbreaks occurred in 2006 and 2010. However, no data on the local knowledge, attitude and practice (KAP) of DF in Nepal exist although such information is required for prevention and control measures. Methods We conducted a community based cross-sectional survey in five districts of central Nepal between September 2011 and February 2012. We collected information on the socio-demographic characteristics of the participants and their knowledge, attitude and practice regarding DF using a structured questionnaire. We then statistically compared highland and lowland communities to identify possible causes of observed differences. Principal Findings Out of 589 individuals interviewed, 77% had heard of DF. Only 12% of the sample had good knowledge of DF. Those living in the lowlands were five times more likely to possess good knowledge than highlanders (P<0.001). Despite low knowledge levels, 83% of the people had good attitude and 37% reported good practice. We found a significantly positive correlation among knowledge, attitude and practice (P<0.001). Among the socio-demographic variables, the education level of the participants was an independent predictor of practice level (P<0.05), and education level and interaction between the sex and age group of the participants were independent predictors of attitude level (P<0.05). Conclusion Despite the rapid expansion of DENV in Nepal, the knowledge of people about DF was very low. Therefore, massive awareness programmes are urgently required to protect the health of people from DF and to limit its further spread in this country. PMID:25007284

Practice-based Research Network Research Good Practices (PRGPs): Summary of Recommendations.

PubMed

Dolor, Rowena J; Campbell-Voytal, Kimberly; Daly, Jeanette; Nagykaldi, Zsolt J; O'Beirne, Maeve; Sterling, Pamela; Fagnan, Lyle J; Levy, Barcey; Michaels, LeAnn; Louks, Hannah A; Smith, Paul; Aspy, Cheryl B; Patterson, V Beth; Kano, Miria; Sussman, Andrew L; Williams, Robert; Neale, Anne Victoria

2015-12-01

Practice-based research networks (PBRNs) conduct research in community settings, which poses quality control challenges to the integrity of research, such as study implementation and data collection. A foundation for improving research processes within PBRNs is needed to ensure research integrity. Network directors and coordinators from seven U.S.-based PBRNs worked with a professional team facilitator during semiannual in-person meetings and monthly conference calls to produce content for a compendium of recommended research practices specific to the context of PBRNs. Participants were assigned to contribute content congruent with their expertise. Feedback on the draft document was obtained from attendees at the preconference workshop at the annual PBRN meeting in 2013. A revised document was circulated to additional PBRN peers prior to finalization. The PBRN Research Good Practices (PRGPs) document is organized into four chapters: (1) Building PBRN Infrastructure; (2) Study Development and Implementation; (3) Data Management, and (4) Dissemination Policies. Each chapter contains an introduction, detailed procedures for each section, and example resources with information links. The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. © 2015 Wiley Periodicals, Inc.

Research on the Implementation of Technological Measures for Controlling Indoor Environmental Quality in Green Residential Buildings

NASA Astrophysics Data System (ADS)

Wang, Ruozhu; Liu, Pengda; Qian, Yongmei

2018-02-01

This paper analyzes the design technology of controlling indoor quality in engineering practice, it is proposed that, in framework system of green residential building design, how to realize the design idea of controlling the indoor environment quality, and the design technology with feasibility, including the sunshine and lighting, indoor air quality and thermal environment, sound insulation and noise reduction measures, etc.. The results of all will provide a good theoretical supportting for the design of green residential building.

Towards practical control design using neural computation

NASA Technical Reports Server (NTRS)

Troudet, Terry; Garg, Sanjay; Mattern, Duane; Merrill, Walter

1991-01-01

The objective is to develop neural network based control design techniques which address the issue of performance/control effort tradeoff. Additionally, the control design needs to address the important issue if achieving adequate performance in the presence of actuator nonlinearities such as position and rate limits. These issues are discussed using the example of aircraft flight control. Given a set of pilot input commands, a feedforward net is trained to control the vehicle within the constraints imposed by the actuators. This is achieved by minimizing an objective function which is the sum of the tracking errors, control input rates and control input deflections. A tradeoff between tracking performance and control smoothness is obtained by varying, adaptively, the weights of the objective function. The neurocontroller performance is evaluated in the presence of actuator dynamics using a simulation of the vehicle. Appropriate selection of the different weights in the objective function resulted in the good tracking of the pilot commands and smooth neurocontrol. An extension of the neurocontroller design approach is proposed to enhance its practicality.

Tuberculosis knowledge, attitudes and practices of patients at primary health care facilities in a South African metropolitan: research towards improved health education.

PubMed

Kigozi, N Gladys; Heunis, J Christo; Engelbrecht, Michelle C; Janse van Rensburg, André P; van Rensburg, H C J Dingie

2017-10-10

Health education is important to empower patients and encourage their contribution towards tuberculosis (TB) control. In South Africa, health education activities are integrated into services provided at the primary health care (PHC) level. This study was conducted in a high TB burden metropolitan area in South Africa. The objective was to assess TB-related knowledge, attitudes and infection control practices of patients attending PHC facilities. In September and October 2015, a cross-sectional survey using fieldworker-administered questionnaires was conducted among patients older than 17 years attending 40 PHC facilities in the Mangaung Metropolitan. Convenience sampling was used to select patients. Participation in the study was voluntary. Descriptive, inferential and multivariate logistic regression analyses were performed. Statistical significance was considered at alpha <0.05 and 95% confidence interval. A total of 507 patients' data were included in the analysis. Most of the patients knew that TB transmission is facilitated by crowded conditions (84.6%) and that pulmonary TB is contagious (73.0%). Surprisingly, the majority of patients also believed that one can get TB from sharing toothbrushes (85.0%) or kissing (65.0%). An overwhelming majority of patients perceived TB to be serious (89.7%), and concurred that taking treatment (97.2%) and opening windows to prevent transmission in PHC facilities (97.0%) are important. Being employed (AOR: 11.5; CI: 4.8-27.6), having received TB infection control information from a PHC facility (AOR: 2.2; CI: 1.5-3.4), and being a TB patient (AOR: 1.6; CI: 1.02-2.46) increased the likelihood of adopting good infection control practices. These findings highlight the need for health education efforts to strengthen accurate information dissemination to promote sound TB knowledge and attitudes among patients attending PHC facilities. Health education efforts should also capitalise on the positive finding of this study that information dissemination at PHC facilities increases good infection control practices.

Narrative Practice and the Signs of Safety Approach: Engaging Adolescents in Building Rigorous Safety Plans

ERIC Educational Resources Information Center

Gibson, Matthew

2014-01-01

The Signs of Safety approach to child protection has been gaining prominence around the world and this approach has developed through learning from good practice. Generally, examples of good practice are derived from adults who pose a risk to children, while this paper outlines an example of good practice that engages an adolescent in building a…

[Design of an HACCP program for a cocoa processing facility].

PubMed

López D'Sola, Patrizia; Sandia, María Gabriela; Bou Rached, Lizet; Hernández Serrano, Pilar

2012-12-01

The HACCP plan is a food safety management tool used to control physical, chemical and biological hazards associated to food processing through all the processing chain. The aim of this work is to design a HACCP Plan for a Venezuelan cocoa processing facility.The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs such as Good Manufacturing Practices (GMP) and Sanitation Standard Operating Procedures (SSOP). The existence and effectiveness of these prerequisite programs were previously assessed.Good Agriculture Practices (GAP) audit to cocoa nibs suppliers were performed. To develop the HACCP plan, the five preliminary tasks and the seven HACCP principles were accomplished according to Codex Alimentarius procedures. Three Critical Control Points (CCP) were identified using a decision tree: winnowing (control of ochratoxin A), roasting (Salmonella control) and metallic particles detection. For each CCP, Critical limits were established, the Monitoring procedures, Corrective actions, Procedures for Verification and Documentation concerning all procedures and records appropriate to these principles and their application was established. To implement and maintain a HACCP plan for this processing plant is suggested. Recently OchratoxinA (OTA) has been related to cocoa beans. Although the shell separation from the nib has been reported as an effective measure to control this chemical hazard, ochratoxin prevalence study in cocoa beans produced in the country is recommended, and validate the winnowing step as well

Community's knowledge, attitudes and practices about tuberculosis in Itang Special District, Gambella Region, South Western Ethiopia.

PubMed

Bati, Jango; Legesse, Mengistu; Medhin, Girmay

2013-08-07

Tuberculosis (TB) is one of the primary public health problems in developing countries. HIV/AIDS, poverty, undernutrition, over-crowded living conditions and lack of knowledge about the disease have been known to increase the risk of spreading the bacteria and the risk of developing the disease. The objective of this study was to assess the level of TB knowledge, attitudes and practices of rural communities of Itang Special District of the Gambella Regional State of Ethiopia. Between November 2011 and January 2012, a community-based cross sectional study was carried out in a randomly selected rural kebeles (i.e. the smallest administrative units) of Itang communities. The study participants were interviewed using pre-tested questionnaire. The overall knowledge, attitudes and practices of the study participants were assessed using the mean score of each outcome as a cut-off value. Having a score above the mean on each of the three target outcomes was equated with having a good level of knowledge, or having favorable attitude and good practices towards TB. Out of 422 study participants (58.5% males and 41.5% females) only 3.3% mentioned bacteria/germ as a cause of pulmonary TB (PTB) and 9.9% mentioned cough for at least two weeks as the sign of TB. Taking the mean knowledge score as the cut-off value, 57.6% (95% CI: 52.7% to 62.3%) of the study participants had good level of knowledge about TB, 40.8% (95% CI: 36.0% to 45.6%) had favorable attitude towards TB and 45.9% (95% CI: 41.1% to 50.9%) had good practices. Female participants were less likely to have good level of knowledge [adjusted odds ratio (AOR) = 0.33, 95% CI, 0.21 to 0.51, p < 0.001], less likely to have favorable attitude (AOR = 0.23, 95% CI, 0.14 to 0.37) and less likely to have good practices (AOR = 0.37, 95% CI, 0.24 to 0.57, p < 0.001) compared to male participants. Majority of the study participants had no correct information about the causative agent of TB and the main symptom of PTB. Moreover, low level of overall knowledge, attitudes and practices about TB was associated with female participants. Hence, TB control strategy in the present study area should include community awareness raising component.

Perceptions of Science Teachers on Implementation of Seven Principles for Good Practice in Education by Chickering and Gamson in Courses

ERIC Educational Resources Information Center

Ugras, Mustafa; Asiltürk, Erol

2018-01-01

The present study aimed to determine the perceptions of science teachers on the implementation of the seven principles for good practice in education by Chickering and Gamson in their courses. Seven principles for good science education were used as a data collection tool in the survey. "The seven principles for good practice in science…

An in-depth analysis of pharmaceutical regulation in the Republic of Moldova

PubMed Central

2014-01-01

Objective Regulation of the pharmaceutical system is a crucial, yet often neglected, component in ensuring access to safe and effective medicines. The aim of this study was to provide an in-depth analysis of the existing pharmaceutical regulation, including recent changes, in the Republic of Moldova. Methods Data from field work conducted by the World Health Organization (WHO) together with a review of policy documents and quantitative secondary data analysis was used to achieve this aim. Results This analysis identified several ways in which pharmaceutical regulation affects availability of quality medicines in the Republic of Moldova. These include lack of full implementation bioequivalence requirements for generics registration, incomplete implementation of good manufacturing practices and no implementation of good distribution practices, use of quality control instead of quality assurance as a method to ensure quality of medicines, frequent change of power within the Medicines and Medical Devices Agency (MMDA) leading to lack of long-term strategy and plans, conflict of interest between the different functions of the MMDA, the lack of sufficient funding for the MMDA to conduct its activities and to invest in continuous training of its staff (particularly inspectors) and very weak post-marketing control. Notably, several improvements have been recently introduced, including a roadmap for change for the MMDA, the introduction of good manufacturing practices and the drafting of a quality manual for the Agency. Conclusion Based on these findings the authors propose a set of priority actions to address existing gaps and draw lessons learned from other countries. PMID:25848544

Techniques for development of safety-related software for surgical robots.

PubMed

Varley, P

1999-12-01

Regulatory bodies require evidence that software controlling potentially hazardous devices is developed to good manufacturing practices. Effective techniques used in other industries assume long timescales and high staffing levels and can be unsuitable for use without adaptation in developing electronic healthcare devices. This paper discusses a set of techniques used in practice to develop software for a particular innovative medical product, an endoscopic camera manipulator. These techniques include identification of potential hazards and tracing their mitigating factors through the project lifecycle.

Financial reporting.

PubMed

Bachrach, D J; Farrell, N L

1985-01-01

"How are we doing?" Financial reports must provide the answer to this all-important question for every medical group. Although there are some key differences between academic practices and private group practices, good financial reports and statements of activity are essential in all situations. Examples are provided here of how financial information can be communicated to the several organizational levels that need the information, as well as how financial planning, measurement, and control are part of this communication process. Sample formats outline the important ingredients for making your group's reports more useful.

Shape-controlled synthesis of nanocarbons through direct conversion of carbon dioxide

NASA Astrophysics Data System (ADS)

Zhang, Haitao; Zhang, Xiong; Sun, Xianzhong; Ma, Yanwei

2013-12-01

Morphology control of carbon-based nanomaterials (nanocarbons) is critical to practical applications because their physical and chemical properties are highly shape-dependent. The discovery of novel shaped nanocarbons stimulates new development in carbon science and technology. Based on direct reaction of CO2 with Mg metal, we achieved controlled synthesis of several different types of nanocarbons including mesoporous graphene, carbon nanotubes, and hollow carbon nanoboxes. The last one, to our knowledge, has not been previously reported to this date. The method described here allows effective control of the shape and dimensions of nanocarbons through manipulation of reaction temperature. The formation mechanism of nanocarbons is proposed. As a proof of concept, the synthesized nanocarbons are used for electrodes in symmetrical supercapacitors, which exhibit high capacitance and good cycling stability. The reported protocols are instructive to production of nanocarbons with controlled shape and dimensions which are much desirable for many practical applications.

Shape-controlled synthesis of nanocarbons through direct conversion of carbon dioxide

PubMed Central

Zhang, Haitao; Zhang, Xiong; Sun, Xianzhong; Ma, Yanwei

2013-01-01

Morphology control of carbon-based nanomaterials (nanocarbons) is critical to practical applications because their physical and chemical properties are highly shape-dependent. The discovery of novel shaped nanocarbons stimulates new development in carbon science and technology. Based on direct reaction of CO2 with Mg metal, we achieved controlled synthesis of several different types of nanocarbons including mesoporous graphene, carbon nanotubes, and hollow carbon nanoboxes. The last one, to our knowledge, has not been previously reported to this date. The method described here allows effective control of the shape and dimensions of nanocarbons through manipulation of reaction temperature. The formation mechanism of nanocarbons is proposed. As a proof of concept, the synthesized nanocarbons are used for electrodes in symmetrical supercapacitors, which exhibit high capacitance and good cycling stability. The reported protocols are instructive to production of nanocarbons with controlled shape and dimensions which are much desirable for many practical applications. PMID:24346481

78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

Conserving and enhancing biological control of nematodes.

PubMed

Timper, Patricia

2014-06-01

Conservation biological control is the modification of the environment or existing practices to protect and enhance antagonistic organisms to reduce damage from pests. This approach to biological control has received insufficient attention compared with inundative applications of microbial antagonists to control nematodes. This review provides examples of how production practices can enhance or diminish biological control of plant-parasitic nematodes and other soilborne pests. Antagonists of nematodes can be enhanced by providing supplementary food sources such as occurs when organic amendments are applied to soil. However, some organic amendments (e.g., manures and plants containing allelopathic compounds) can also be detrimental to nematode antagonists. Plant species and genotype can strongly influence the outcome of biological control. For instance, the susceptibility of the plant to the nematode can determine the effectiveness of control; good hosts will require greater levels of suppression than poor hosts. Plant genotype can also influence the degree of rhizosphere colonization and antibiotic production by antagonists, as well the expression of induced resistance by plants. Production practices such as crop rotation, fallow periods, tillage, and pesticide applications can directly disrupt populations of antagonistic organisms. These practices can also indirectly affect antagonists by reducing their primary nematode host. One of the challenges of conservation biological control is that practices intended to protect or enhance suppression of nematodes may not be effective in all field sites because they are dependent on indigenous antagonists. Ultimately, indicators will need to be identified, such as the presence of particular antagonists, which can guide decisions on where it is practical to use conservation biological control. Antagonists can also be applied to field sites in conjunction with conservation practices to improve the consistency, efficacy, and duration of biological control. In future research, greater use should be made of bioassays that measure nematode suppression because changes in abundance of particular antagonists may not affect biological control of plant parasites.

Conserving and Enhancing Biological Control of Nematodes

PubMed Central

Timper, Patricia

2014-01-01

Conservation biological control is the modification of the environment or existing practices to protect and enhance antagonistic organisms to reduce damage from pests. This approach to biological control has received insufficient attention compared with inundative applications of microbial antagonists to control nematodes. This review provides examples of how production practices can enhance or diminish biological control of plant-parasitic nematodes and other soilborne pests. Antagonists of nematodes can be enhanced by providing supplementary food sources such as occurs when organic amendments are applied to soil. However, some organic amendments (e.g., manures and plants containing allelopathic compounds) can also be detrimental to nematode antagonists. Plant species and genotype can strongly influence the outcome of biological control. For instance, the susceptibility of the plant to the nematode can determine the effectiveness of control; good hosts will require greater levels of suppression than poor hosts. Plant genotype can also influence the degree of rhizosphere colonization and antibiotic production by antagonists, as well the expression of induced resistance by plants. Production practices such as crop rotation, fallow periods, tillage, and pesticide applications can directly disrupt populations of antagonistic organisms. These practices can also indirectly affect antagonists by reducing their primary nematode host. One of the challenges of conservation biological control is that practices intended to protect or enhance suppression of nematodes may not be effective in all field sites because they are dependent on indigenous antagonists. Ultimately, indicators will need to be identified, such as the presence of particular antagonists, which can guide decisions on where it is practical to use conservation biological control. Antagonists can also be applied to field sites in conjunction with conservation practices to improve the consistency, efficacy, and duration of biological control. In future research, greater use should be made of bioassays that measure nematode suppression because changes in abundance of particular antagonists may not affect biological control of plant parasites. PMID:24987159

Indonesian journalistic competitions: tribute or threat for press practice

NASA Astrophysics Data System (ADS)

Dewi, P. A. R.; Aji, G. G.; Sukardani, P. S.

2018-01-01

This research aims to Investigate journalists’ understanding toward glittering generalities practice - positive and good coverage of the caused by the Journalistic contests, the prices are attracting them, Reviews their motives to Participate, and their beliefs about ethics al thing. It is also retrieve how the chief editor, as a decision maker in the mass media taking his responsibility on the glittering news. This research uses a case study method by conducting indepth interviews on journalists, editors, and professional the alliance to collect the data and analyse it based on critical paradigm. The results show that journalist believe that competition is good, and there is no violation as long as the stick to the press code of conduct, but for chief editors and professional alliance, they begin to aware the damage of the contest. The findings of this work will be valuable to develop critical thinking of press workers and promote awareness to the society to control the media practice.

A Multi-Site Knowledge Attitude and Practice Survey of Ebola Virus Disease in Nigeria

PubMed Central

Iliyasu, Garba; Ogoina, Dimie; Otu, Akan A.; Dayyab, Farouq M.; Ebenso, Bassey; Otokpa, Daniel; Rotifa, Stella; Olomo, Wisdom T.; Habib, Abdulrazaq G.

2015-01-01

Background The 2014 Ebola Virus Disease (EVD) outbreak was characterised by fear, misconceptions and irrational behaviours. We conducted a knowledge attitude and practice survey of EVD in Nigeria to inform implementation of effective control measures. Methods Between July 30th and September 30th 2014, we undertook a cross sectional study on knowledge, attitude and practice (KAP) of Ebola Virus Disease (EVD) among adults of the general population and healthcare workers (HCW) in three states of Nigeria, namely Bayelsa, Cross River and Kano states. Demographic information and data on KAP were obtained using a self-administered standardized questionnaire. The percentage KAP scores were categorised as good and poor. Independent predictors of good knowledge of EVD were ascertained using a binary logistic regression model. Results Out of 1035 study participants with median age of 32 years, 648 (62.6%) were males, 846 (81.7%) had tertiary education and 441 (42.6%) were HCW. There were 218, 239 and 578 respondents from Bayelsa, Cross River and Kano states respectively. The overall median percentage KAP scores and interquartile ranges (IQR) were 79.46% (15.07%), 95.0% (33.33%) and 49.95% (37.50%) respectively. Out of the 1035 respondents, 470 (45.4%), 544(52.56%) and 252 (24.35%) had good KAP of EVD defined using 80%, 90% and 70% score cut-offs respectively. Independent predictors of good knowledge of EVD were being a HCW (Odds Ratio-OR-2.89, 95% Confidence interval-CI of 1.41–5.90), reporting ‘moderate to high fear of EVD’ (OR-2.15, 95% CI-(1.47–3.13) and ‘willingness to modify habit’ (OR-1.68, 95% CI-1.23–2.30). Conclusion Our results reveal suboptimal EVD-related knowledge, attitude and practice among adults in Nigeria. To effectively control future outbreaks of EVD in Nigeria, there is a need to implement public sensitization programmes that improve understanding of EVD and address EVD-related myths and misconceptions, especially among the general population. PMID:26317535

[Positive deviance: concept analysis using the evolutionary approach of Rodgers].

PubMed

Létourneau, Josiane; Alderson, Marie; Caux, Chantal; Richard, Lucie

2013-06-01

Positive deviance is a relatively new concept in healthcare. Since 2006, it has been applied to infection control in order to increase the awareness to good hand hygiene practices. This article focus on presenting analytical results of this concept using the evolutionary approach of Rodgers based on the philosophical postulate that concepts are dynamical and changing with time. For doing so, a census of the writings in nursing, medicine and psychology was carried out. By going through the CINAHL, Medline and PsyclNFO databases using positive deviance as a keyword for the time period: 1975 to May 2012, and in accordance with the method of Rodgers, ninety articles were retained (30 per discipline). The analysis enables one to notice that positive deviance described as an individual characteristic at first, is now used as a behavioral changing approach in nursing and medicine as well. At the end of the analysis and apart from this article, positive deviance will be used in order to study the practice of nurses that adheres to hand hygiene despite limiting constraints within hospital. We will then be able to continue the development of this concept in order to bring it, as Rodgers recommends, beyond the analysis. It would then be an important contribution to good nursing practices in the field of infection control and prevention.

21 CFR 123.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 123.5 Section...) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods...

21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Applicability of current good manufacturing practice regulations. 210.2 Section 210.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

ERIC Educational Resources Information Center

Hanson, Jana M.; Paulsen, Michael B.; Pascarella, Ernest T.

2016-01-01

This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at 4-year colleges and universities in the USA. We examined whether eight good teaching practices (non-classroom interactions with faculty, prompt…

Integrating Education: Parekhian Multiculturalism and Good Practice

ERIC Educational Resources Information Center

McGlynn, Claire

2009-01-01

This paper explores the concept of good practice in integrating education in divided societies. Using Northern Ireland as a case study, the paper draws on data from eight schools (both integrated Catholic and Protestant, and separate) that are identified as exemplifying good practice in response to cultural diversity. Analysis is provided through…

78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by... performance of a tobacco product), packing, and storage of a tobacco product conform to current good... group of 13 tobacco companies submitted to FDA: (1) Recommendations for good manufacturing practice...

Electronic monitoring of adherence to inhaled corticosteroids: an essential tool in identifying severe asthma in children.

PubMed

Jochmann, Anja; Artusio, Luca; Jamalzadeh, Angela; Nagakumar, Prasad; Delgado-Eckert, Edgar; Saglani, Sejal; Bush, Andrew; Frey, Urs; Fleming, Louise J

2017-12-01

International guidelines recommend that severe asthma can only be diagnosed after contributory factors, including adherence, have been addressed. Accurate assessment of adherence is difficult in clinical practice. We hypothesised that electronic monitoring in children would identify nonadherence, thus delineating the small number with true severe asthma.Asthmatic children already prescribed inhaled corticosteroids were prospectively recruited and persistence of adherence assessed using electronic monitoring devices. Spirometry, airway inflammation and asthma control were measured at the start and end of the monitoring period.93 children (62 male; median age 12.4 years) were monitored for a median of 92 days. Median (range) monitored adherence was 74% (21-99%). We identified four groups: 1) good adherence during monitoring with improved control, 24% (likely previous poor adherence); 2) good adherence with poor control, 18% (severe therapy-resistant asthma); 3) poor adherence with good control, 26% (likely overtreated); and 4) poor adherence with poor control, 32%. No clinical parameter prior to monitoring distinguished these groups.Electronic monitoring is a useful tool for identifying children in whom a step up in treatment is indicated. Different approaches are needed in those who are controlled when adherent or who are nonadherent. Electronic monitoring is essential in a paediatric severe asthma clinic. Copyright ©ERS 2017.

The effects of practice on movement distance and final position reproduction: implications for the equilibrium-point control of movements.

PubMed

Jaric, S; Corcos, D M; Gottlieb, G L; Ilic, D B; Latash, M L

1994-01-01

Predictions of two views on single-joint motor control, namely programming of muscle force patterns and equilibrium-point control, were compared with the results of experiments with reproduction of movement distance and final location during fast unidirectional elbow flexions. Two groups of subjects were tested. The first group practiced movements over a fixed distance (36 degrees), starting from seven different initial positions (distance group, DG). The second group practiced movements from the same seven initial positions to a fixed final location (location group, LG). Later, all the subjects were tested at the practiced task with their eyes closed, and then, unexpectedly for the subjects, they were tested at the other, unpracticed task. In both groups, the task to reproduce final position had lower indices of final position variability than the task to reproduce movement distance. Analysis of the linear regression lines between initial position and final position (or movement distance) also demonstrated a better (more accurate) performance during final position reproduction than during distance reproduction. The data are in a good correspondence with the predictions of the equilibrium-point hypothesis, but not with the predictions of the force-pattern control approach.

Perceptions of good medical practice in the NHS: a survey of senior health professionals.

PubMed

Hutchinson, A; Williams, M; Meadows, K; Barbour, R S; Jones, R

1999-12-01

To categorize senior health professionals' experience with poor medical practice in hospitals and in general practice, to describe perceptions which senior NHS staff have of good medical practice, and to describe how problems of poor medical practice are currently managed. A postal questionnaire survey. The questionnaire sought perceptions of good medical practice, asked participants to characterise deviations from good practice, and to describe experience with managing poor performance at the time of the introduction of the General Medical Council (GMC) performance procedures. A range of NHS settings in the UK: hospital trusts, health authorities/boards, local medical committees, community health councils. Senior health professionals involved in the management of medical professional performance. Perceptions of what constitutes good medical practice. Most respondents considered that persistent problems related to clinical practice (diagnosis, management, and outcome and prescribing) would require local management and, possibly, referral to the GMC performance procedures. Informal mechanisms, including informal discussion, education, training, and work shifting, were the most usual means of handling a doctor whose performance was poor. Many took a less serious view of deficiencies in performance on manner and attitude and communication, although consultation skills rather than technical skills comprised the greatest number of complaints about doctors. Senior NHS professionals seem reluctant to consider persistently poor consultation skills in the same critical light as they do persistently poor technical practice. These attitudes may need to change with the implementation of clinical governance and updated guidance from the GMC on what constitutes good medical practice.

[Integrated Management Area of Vascular Risk: A new organisational model for global control of risk factors].

PubMed

Armario, P; Jericó, C; Vila, L; Freixa, R; Martin-Castillejos, C; Rotllan, M

Cardiovascular disease (CVD), is a major cause of morbidity and mortality that increases the cost of care. Currently there is a low degree of control of the main cardiovascular risk factors, although we have a good therapeutic arsenal. To achieve the improvement of this reality, a good coordination and multidisciplinary participation are essential. The development of new organizational models such as the Integrated Management Area of Vascular Risk can facilitate the therapeutic harmonization and unification of the health messages offered by different levels of care, based on clinical practice guidelines, in order to provide patient-centred integrated care. Copyright © 2016 SEH-LELHA. Publicado por Elsevier España, S.L.U. All rights reserved.

Microbial control and food Preservation: Theory and practice:Principles of food preservation

USDA-ARS?s Scientific Manuscript database

Food preservation is an action or method used to maintain foods at certain desirable properties or quality to obtain maximum benefit. A good method of food preservation is one that slows down or prevents altogether the action of the agents of spoilage without damaging the food. To achieve this, cert...

Reflections on Doing Inclusive Research in the "Making Life Good in the Community" Study

ERIC Educational Resources Information Center

Bigby, Christine; Frawley, Patsie

2010-01-01

Background: The involvement of people with intellectual disability in research is framed as inclusive, denoting their active participation in its processes. However, questions are raised about ownership and control, genuineness of involvement, and the need for honest accounts to develop practice. Such issues are particularly pressing in Australia,…

Jar Test. Operational Control Tests for Wastewater Treatment Facilities. Instructor's Manual [and] Student Workbook.

ERIC Educational Resources Information Center

Arasmith, E. E.

The jar test is used to determine the proper chemical dosage required for good coagulation and flocculation of water. The test is commonly used in potable water, secondary effluent prior to advanced wastewater treatment, secondary clarifier influent, and sludge conditioning practice. Designed for individuals who have completed National Pollutant…

76 FR 37814 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

... laboratory studies with good laboratory practices, (4) name and address of each clinical investigator, (5... assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected... technology. New Animal Drugs for Investigational Uses--21 CFR Part 511 (OMB Control Number 0910-0117...

49 CFR 1180.1 - General policy statement for merger or control of at least two Class I railroads.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE RAILROAD... the railroad industry (including Class II and III carriers) is a network of competing and... weight in our analysis. Applicants shall make a good faith effort to calculate the net public benefits...

49 CFR 1180.1 - General policy statement for merger or control of at least two Class I railroads.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE RAILROAD... the railroad industry (including Class II and III carriers) is a network of competing and... weight in our analysis. Applicants shall make a good faith effort to calculate the net public benefits...

49 CFR 1180.1 - General policy statement for merger or control of at least two Class I railroads.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE RAILROAD... the railroad industry (including Class II and III carriers) is a network of competing and... weight in our analysis. Applicants shall make a good faith effort to calculate the net public benefits...

49 CFR 1180.1 - General policy statement for merger or control of at least two Class I railroads.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE RAILROAD... the railroad industry (including Class II and III carriers) is a network of competing and... weight in our analysis. Applicants shall make a good faith effort to calculate the net public benefits...

40 CFR 60.4333 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2011 CFR

2011-07-01

... consistent with good air pollution control practices for minimizing emissions at all times including during startup, shutdown, and malfunction. (b) When an affected unit with heat recovery utilizes a common steam... the other unit(s) utilizing the common heat recovery unit; or (2) Develop, demonstrate, and provide...

40 CFR 60.4333 - What are my general requirements for complying with this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... consistent with good air pollution control practices for minimizing emissions at all times including during startup, shutdown, and malfunction. (b) When an affected unit with heat recovery utilizes a common steam... the other unit(s) utilizing the common heat recovery unit; or (2) Develop, demonstrate, and provide...

Good manufacturing practice and viral safety.

PubMed

Kerner, B

1995-07-01

The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

Knowledge, attitudes and practices of traceability among livestock traders in south-western Nigeria: implications for sustainable livestock industry.

PubMed

Adesokan, Hezekiah K; Ocheja, Samuel E

2014-01-01

Livestock diseases and other animal health events are a threat to achieving sustainable livestock industry. The knowledge of trace-back and the practice of providing feedback on diseases encountered in slaughtered animals from the abattoir to the farm can help limit the spread as well as manage potential future incidents of such diseases. We assessed the knowledge, attitudes and practices of 200 willing livestock traders on traceability in Bodija Municipal Abattoir, south-western Nigeria. The results reveal that the majority of these traders had poor knowledge (79.5 %) and practices (74.0 %) of traceability, though 89.5 % demonstrated good attitudes. While 22.9 % knew that traceability could be an effective means to control diseases, only a lower proportion (9.0 %) knew the health status of the animals being purchased. Though 29.0 % reported the diseases encountered in their animals during slaughter to the farm, only 9.5 % followed up to ensure the farmers take steps at preventing further occurrence of the reported diseases. While age (p = 0.000; 0.014) and education (p = 0.000; 0.000) were both significant for good knowledge and attitudes, frequency of condemned cases (p = 0.000) and length of years in the trade (p = 0.004) were, respectively, significant for good knowledge and attitudes with none associated with practice. These poor levels of knowledge and practices of traceability are a threat to sustainable livestock industry, food security and human health; hence, there is an urgent need to institute national feedback mechanism on slaughtered animals in order to strengthen interventions against diseases at farm levels.

Investigating School-Wide Antecedents of Good Practice Dissemination from Individual Subject Projects

ERIC Educational Resources Information Center

Christophersen, Knut-Andreas; Elstad, Eyvind; Turmo, Are

2012-01-01

Good practice dissemination is an unsolved problem in education. This article describes how clear and "soft" leadership and perceptions of social and economic exchange operate in the bottom-up processes of school reforms and examines the relative impact of these factors on school-wide good practice dissemination and discusses how…

The Conditional Nature of High Impact/Good Practices on Student Learning Outcomes

ERIC Educational Resources Information Center

Seifert, Tricia A.; Gillig, Benjamin; Hanson, Jana M.; Pascarella, Ernest T.; Blaich, Charles F.

2014-01-01

Using a multi-institutional sample of undergraduate students, this study found that the relationships between engaging in high impact/good practices and liberal arts outcomes differ based on students' precollege and background characteristics. Findings suggest that high impact/good practices are not a panacea and require a greater degree of…

Good Practices for Transforming Education

ERIC Educational Resources Information Center

Benavente, Ana; Panchaud, Christine

2008-01-01

This text is a guide to the reading and interpretation of the "good practices" that are developing in the countries participating in this project and elsewhere. A systematic approach to the factors making up a "good practice" has enabled us to share our analyses in a more structured manner and to reflect on their potential for…

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What is current good manufacturing practice for PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION...

40 CFR 86.098-23 - Required data.

Code of Federal Regulations, 2010 CFR

2010-07-01

... accordance with good engineering practice to assure that the engines covered by a certificate issued under... and conducted in accordance with good engineering practice to assure that the vehicles covered by a... systems are designed, using good engineering practice, to meet the standards of § 86.096-10 or § 86.098-11...

Good Laboratory Practice. Part 3. Implementing Good Laboratory Practice in the Analytical Lab

ERIC Educational Resources Information Center

Wedlich, Richard C.; Pires, Amanda; Fazzino, Lisa; Fransen, Joseph M.

2013-01-01

Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide…

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2012 CFR

2012-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2011 CFR

2011-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2013 CFR

2013-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

Cytomegalovirus (CMV) and Pregnancy

MedlinePlus

... way to prevent infection is to practice good hygiene, particularly proper hand washing. An interventional study in ... a CMV infection found that teaching about good hygiene (and practicing good hygiene) reduced the risk of ...

Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.

PubMed

2004-11-24

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

Examples of actions that improve partnering cooperation among the participants of construction projects

NASA Astrophysics Data System (ADS)

Radziszewska-Zielina, E.; Szewczyk, B.

2017-10-01

The aim of the article is to present examples of actions that can be undertaken in order to improve partnering cooperation in construction projects. These actions are a practical supplementation to the previously developed fuzzy system of controlling partnering relations in construction projects. The actions relate to 18 parameters of partnering relations that describe cooperation between a general contractor or a company that manages the project and four other participants: the contractors (subcontractors), the designer, the material and equipment suppliers and the real estate developer. The actions have been listed based on a review of subject literature, self-analysis, as well as interviews with participants of construction projects. They can provide examples of good practices that maintain partnering cooperation at a high level. Good cooperation, in turn, translates into a better performance of the project.

Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making.

PubMed

Berger, Marc L; Sox, Harold; Willke, Richard J; Brixner, Diana L; Eichler, Hans-Georg; Goettsch, Wim; Madigan, David; Makady, Amr; Schneeweiss, Sebastian; Tarricone, Rosanna; Wang, Shirley V; Watkins, John; Mullins, C Daniel

2017-09-01

Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders. Copyright © 2017. Published by Elsevier Inc.

21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good manufacturing...

75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

.... FDA-1999-N-3539] (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. 0 Therefore, under the...

Monitoring clinical standards in a chronic peritoneal dialysis program.

PubMed

Leung, Dora K C

2009-02-01

Multiple factors may influence the effectiveness of a chronic peritoneal dialysis program. Continuous monitoring of various aspects of clinical standards with reviews enhances opportunities for bridging the gap between existing practice and good practice, and good practice to best practice.

A wavenumber approach to analysing the active control of plane waves with arrays of secondary sources

NASA Astrophysics Data System (ADS)

Elliott, Stephen J.; Cheer, Jordan; Bhan, Lam; Shi, Chuang; Gan, Woon-Seng

2018-04-01

The active control of an incident sound field with an array of secondary sources is a fundamental problem in active control. In this paper the optimal performance of an infinite array of secondary sources in controlling a plane incident sound wave is first considered in free space. An analytic solution for normal incidence plane waves is presented, indicating a clear cut-off frequency for good performance, when the separation distance between the uniformly-spaced sources is equal to a wavelength. The extent of the near field pressure close to the source array is also quantified, since this determines the positions of the error microphones in a practical arrangement. The theory is also extended to oblique incident waves. This result is then compared with numerical simulations of controlling the sound power radiated through an open aperture in a rigid wall, subject to an incident plane wave, using an array of secondary sources in the aperture. In this case the diffraction through the aperture becomes important when its size is compatible with the acoustic wavelength, in which case only a few sources are necessary for good control. When the size of the aperture is large compared to the wavelength, and diffraction is less important but more secondary sources need to be used for good control, the results then become similar to those for the free field problem with an infinite source array.

16 CFR 453.4 - Required purchase of funeral goods or funeral services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Required purchase of funeral goods or funeral services. 453.4 Section 453.4 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES FUNERAL INDUSTRY PRACTICES § 453.4 Required purchase of funeral goods or funeral services. (a) Casket for cremation provisions—(1) Unfair or...

21 CFR 114.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 114.5 Section...) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part...

The Future of HPT Depends on Whether Practitioners Focus on Foundations or Fads

ERIC Educational Resources Information Center

Brethower, Dale M.

2012-01-01

The future of human performance technology (HPT) will be bright or dismal depending on how well HPT practitioners focus on careful and practical answers to three pivotal questions: What is good practice in human performance technology? What are the differences between good practice and bad? What are the connections between good research and…

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2013 CFR

2013-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2012 CFR

2012-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

Implementing Good Practices Programs to Encourage Production of High-Quality, Safer Produce in Mississippi

ERIC Educational Resources Information Center

Mahmoud, Barakat S. M.; Stafne, Eric T.; Coker, Christine H.; Bachman, Gary R.; Bell, Nicole

2016-01-01

Fifty-four growers/producers attended four 1-day good agricultural practices (GAP) and good handling practices (GHP) workshops at four locations in Mississippi. Pre- and post workshop survey data indicated that the participants' food safety knowledge increased by 15%. Furthermore, the workshops helped producers develop their own food safety plans.…

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth report.

PubMed

2016-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.

Effectiveness of peer-led education on knowledge, attitude and risk behavior practices related to HIV among students at a Malaysian public university--a randomized controlled trial.

PubMed

Ibrahim, Normala; Rampal, Lekhraj; Jamil, Zubaidah; Zain, Azhar Mohd

2012-11-01

Develop, implement and evaluate the effectiveness of a peer-led education program related to HIV/AIDS among university students. randomized controlled trial with 276 university students at Faculty of Medicine and Health Sciences University Putra Malaysia (UPM), Serdang in 2011. A peer-led education program on HIV prevention by university students. differences in knowledge, attitude and risk behavior practices related to HIV between baselines, immediate follow-up after intervention and after three months. Significant improvement in sound knowledge in the intervention group as compared to the control group (Odds ratio, 1.75; 95% CI 1.01, 3.00; p=0.04) and improvement in good attitude related to HIV (Odds ratio 2.22; 95% CI 1.37, 3.61; p=0.01). The odds of high substance risk behavior was significantly reduced in the intervention group as compared to the control group (Odds ratio 0.07; 95% CI 0.02, 0.34; p=0.01). The association between good knowledge and intervention was modified by the different time points (baseline, immediately after intervention and 3 months after intervention), ethnicity and gender. Peer-led education program in HIV prevention improves knowledge, attitude and substance risk behavior. Changes in sexual risk behavior may require a longer follow-up. Copyright © 2012 Elsevier Inc. All rights reserved.

Good governance in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

NASA Astrophysics Data System (ADS)

Wee, Seow Ta; Abas, Muhamad Azahar; Mohamed, Sulzakimin; Chen, Goh Kai; Zainal, Rozlin

2017-10-01

The National Solid Waste Management Policy (NSWMP) was introduced in 2007 under the Act 672. The execution of NSWMP involves stakeholders from various government agencies and a collaboration with the private sectors. Despite the initiatives taken by the stakeholders, the objectives of NSWMP failed to materialise. One of the major constraints is weak governance among stakeholders with regards to the NSWMP implementation. This paper will explore the good governance practices implemented by the stakeholders. Identifying the current good governance practices implemented by the stakeholders is crucial as it will serve as a guideline to improve good governance practice in the future. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires involved in the NSWMP implementation. A total of six respondents took part in this study. The findings of this study show that there are several good governance practices implemented in policy promotion, participation of stakeholders, and capacity enhancement programme for the staff. This study also proposed some points on good governance practices in the context of policy promotion and staff development. A paradigm shift by the stakeholders is imperative so as to enhance the good governance practice in NSWMP implementation towards an efficient solid waste management in Malaysia.

Managing the Risk of Occupational Allergy in the Enzyme Detergent Industry

PubMed Central

Basketter, David A.; Kruszewski, Francis H.; Mathieu, Sophie; Kirchner, Donald Bruce; Panepinto, Anthony; Fieldsend, Mark; Siegert, Volker; Barnes, Fiona; Bookstaff, Robert; Simonsen, Merete; Concoby, Beth

2015-01-01

Enzyme proteins have potential to cause occupational allergy/asthma. Consequently, as users of enzymes in formulated products, detergents manufacturers have implemented a number of control measures to ensure that the hazard does not translate into health effects in the workforce. To that end, trade associations have developed best practice guidelines which emphasize occupational hygiene and medical monitoring as part of an effective risk management strategy. The need for businesses to recognize the utility of this guidance is reinforced by reports where factories which have failed to follow good industrial hygiene practices have given rise to incidences of occupational allergy. In this article, an overview is provided of how the industry guidelines are actually implemented in practice and what experience is to be derived therefrom. Both medical surveillance and air monitoring practices associated with the implementation of industry guidelines at approximately 100 manufacturing facilities are examined. The data show that by using the approaches described for the limitation of exposure, for the provision of good occupational hygiene and for the active monitoring of health, the respiratory allergenic risk associated with enzyme proteins can be successfully managed. This therefore represents an approach that could be recommended to other industries contemplating working with enzymes. PMID:25692928

Managing the Risk of Occupational Allergy in the Enzyme Detergent Industry.

PubMed

Basketter, David A; Kruszewski, Francis H; Mathieu, Sophie; Kirchner, Donald Bruce; Panepinto, Anthony; Fieldsend, Mark; Siegert, Volker; Barnes, Fiona; Bookstaff, Robert; Simonsen, Merete; Concoby, Beth

2015-01-01

Enzyme proteins have potential to cause occupational allergy/asthma. Consequently, as users of enzymes in formulated products, detergents manufacturers have implemented a number of control measures to ensure that the hazard does not translate into health effects in the workforce. To that end, trade associations have developed best practice guidelines which emphasize occupational hygiene and medical monitoring as part of an effective risk management strategy. The need for businesses to recognize the utility of this guidance is reinforced by reports where factories which have failed to follow good industrial hygiene practices have given rise to incidences of occupational allergy. In this article, an overview is provided of how the industry guidelines are actually implemented in practice and what experience is to be derived therefrom. Both medical surveillance and air monitoring practices associated with the implementation of industry guidelines at approximately 100 manufacturing facilities are examined. The data show that by using the approaches described for the limitation of exposure, for the provision of good occupational hygiene and for the active monitoring of health, the respiratory allergenic risk associated with enzyme proteins can be successfully managed. This therefore represents an approach that could be recommended to other industries contemplating working with enzymes.

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

PubMed

Gaus, Wilhelm; Muche, Rainer

2013-05-01

Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

Randomized controlled trial of a good practice approach to treatment of childhood obesity in Malaysia: Malaysian Childhood Obesity Treatment Trial (MASCOT).

PubMed

Wafa, Sharifah W; Talib, Ruzita A; Hamzaid, Nur H; McColl, John H; Rajikan, Roslee; Ng, Lai O; Ramli, Ayiesah H; Reilly, John J

2011-06-01

Few randomized controlled trials (RCTs) of interventions for the treatment of childhood obesity have taken place outside the Western world. To test whether a good practice intervention for the treatment of childhood obesity would have a greater impact on weight status and other outcomes than a control condition in Kuala Lumpur, Malaysia. Assessor-blinded RCT of a treatment intervention in 107 obese 7- to 11-year olds. The intervention was relatively low intensity (8 hours contact over 26 weeks, group based), aiming to change child sedentary behavior, physical activity, and diet using behavior change counselling. Outcomes were measured at baseline and six months after the start of the intervention. Primary outcome was BMI z-score, other outcomes were weight change, health-related quality of life (Peds QL), objectively measured physical activity and sedentary behavior (Actigraph accelerometry over 5 days). The intervention had no significant effect on BMI z score relative to control. Weight gain was reduced significantly in the intervention group compared to the control group (+1.5 kg vs. +3.5 kg, respectively, t-test p < 0.01). Changes in health-related quality of life and objectively measured physical activity and sedentary behavior favored the intervention group. Treatment was associated with reduced rate of weight gain, and improvements in physical activity and quality of life. More substantial benefits may require longer term and more intensive interventions which aim for more substantive lifestyle changes.

Design of Moisture Content Detection System

NASA Astrophysics Data System (ADS)

Wang, W. C.; Wang, L.

In this paper, a method for measuring the moisture content of grain was presented based on single chip microcomputer and capacitive sensor. The working principle of measuring moisture content is introduced and a concentric cylinder type of capacitive sensor is designed, the signal processing circuits of system are described in details. System is tested in practice and discussions are made on the various factors affecting the capacitive measuring of grain moisture based on the practical experiments, experiment results showed that the system has high measuring accuracy and good controlling capacity.

Managing vulnerabilities and achieving compliance for Oracle databases in a modern ERP environment

NASA Astrophysics Data System (ADS)

Hölzner, Stefan; Kästle, Jan

In this paper we summarize good practices on how to achieve compliance for an Oracle database in combination with an ERP system. We use an integrated approach to cover both the management of vulnerabilities (preventive measures) and the use of logging and auditing features (detective controls). This concise overview focusses on the combination Oracle and SAP and it’s dependencies, but also outlines security issues that arise with other ERP systems. Using practical examples, we demonstrate common vulnerabilities and coutermeasures as well as guidelines for the use of auditing features.

Good Practice and Recommendations for Research Team Leadership

DTIC Science & Technology

2017-05-01

ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for Research Team Leadership by Mark L...Do not return it to the originator. ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for...information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services , Directorate for Information

Impacts of Good Practices on Cognitive Development, Learning Orientations, and Graduate Degree Plans during the First Year of College

ERIC Educational Resources Information Center

Cruce, Ty M.; Wolniak, Gregory C.; Seifert, Tricia A.; Pascarella, Ernest T.

2006-01-01

This study estimated separately the unique effects of three dimensions of good practice and the global effects of a composite measure of good practices on the cognitive development, orientations to learning, and educational aspirations of students during their first year of college. Analyses of longitudinal data from a representative sample of…

Knowledge for the good of the individual and society: linking philosophy, disciplinary goals, theory, and practice.

PubMed

McCurry, Mary K; Revell, Susan M Hunter; Roy, Sr Callista

2010-01-01

Nursing as a profession has a social mandate to contribute to the good of society through knowledge-based practice. Knowledge is built upon theories, and theories, together with their philosophical bases and disciplinary goals, are the guiding frameworks for practice. This article explores a philosophical perspective of nursing's social mandate, the disciplinary goals for the good of the individual and society, and one approach for translating knowledge into practice through the use of a middle-range theory. It is anticipated that the integration of the philosophical perspective and model into nursing practice will strengthen the philosophy, disciplinary goal, theory, and practice links and expand knowledge within the discipline. With the focus on humanization, we propose that nursing knowledge for social good will embrace a synthesis of the individual and the common good. This approach converges vital and agency needs described by Hamilton and the primacy of maintaining the heritage of the good within the human species as outlined by Maritain. Further, by embedding knowledge development in a changing social and health care context, nursing focuses on the goals of clinical reasoning and action. McCubbin and Patterson's Double ABCX Model of Family Adaptation was used as an example of a theory that can guide practice at the community and global level. Using the theory-practice link as a foundation, the Double ABCX model provides practising nurses with one approach to meet the needs of individuals and society. The integration of theory into nursing practice provides a guide to achieve nursing's disciplinary goals of promoting health and preventing illness across the globe. When nursing goals are directed at the synthesis of the good of the individual and society, nursing's social and moral mandate may be achieved.

Pedestrian Safety: Injury Control Curriculum Guide (For K - 3rd Grade). Second Edition.

ERIC Educational Resources Information Center

Wooner, Rosestelle B., Ed.

This curriculum guide attempts to help the early childhood teacher show children how to incorporate safety precautions into daily life. Good safety practices can prevent the death or injury of young children by automobile, truck, bus, pedestrian, bicycle, and tricycle accidents. The guide focuses on student involvement in the learning process and…

The Good, the Bad and the Ugly? The Dynamic Interplay between Educational Practice, Policy and Research

ERIC Educational Resources Information Center

Van Geert, Paul; Steenbeek, Henderien

2014-01-01

The notion of complexity--as in "education is a complex system"--has two different meanings. On the one hand, there is the epistemic connotation, with "Complex" meaning "difficult to understand, hard to control". On the other hand, complex has a technical meaning, referring to systems composed of many interacting…

78 FR 69602 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Extension of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2011-N-0143] RIN 0910-AG64 Foreign Supplier Verification Programs for Importers of Food for Humans and...

Consuming Prose: The Delectable Rhetoric of Food Writing

ERIC Educational Resources Information Center

Bloom, Lynn Z.

2008-01-01

Food writing, like cooking, offers control over at least a small slice of an otherwise refractory world. As practiced by writers so good that whether they can cook or not is beside the point, food writing is most often upbeat and nurturing, providing successes and triumphs--modest and major--for readers to feast on, with occasional glimpses of…

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges.

PubMed

Sivris, Kelly C; Leka, Stavroula

2015-12-01

While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013-2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation.

Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges

PubMed Central

Sivris, Kelly C.; Leka, Stavroula

2015-01-01

Background While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Methods Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. Results The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013–2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. Conclusion The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation. PMID:26929841

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 1780.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 1780.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

An Accurate Transmitting Power Control Method in Wireless Communication Transceivers

NASA Astrophysics Data System (ADS)

Zhang, Naikang; Wen, Zhiping; Hou, Xunping; Bi, Bo

2018-01-01

Power control circuits are widely used in transceivers aiming at stabilizing the transmitted signal power to a specified value, thereby reducing power consumption and interference to other frequency bands. In order to overcome the shortcomings of traditional modes of power control, this paper proposes an accurate signal power detection method by multiplexing the receiver and realizes transmitting power control in the digital domain. The simulation results show that this novel digital power control approach has advantages of small delay, high precision and simplified design procedure. The proposed method is applicable to transceivers working at large frequency dynamic range, and has good engineering practicability.

Simulation of changes on the psychosocial risk in the nursing personnel after implementing the policy of good practices on the risk treatment.

PubMed

Bolívar Murcia, María Paula; Cruz González, Joan Paola; Rodríguez Bello, Luz Angélica

2018-02-01

Evaluate the change over time of psychosocial risk management for the nursing personnel of an intermediate complexity clinic of Bogota (Colombia). Descriptive and correlational research performed under the approach of risk management (identification, analysis, assessment and treatment). The psychosocial risk of the nursing personnel was studied through 10-year system dynamics models (with and without the implementation of the policy of good practices on the risk treatment) in two scenarios: when the nursing personnel works shifts of 6 hours (morning or afternoon) and when they work over 12 hours (double shift or night shift). When implementing a policy of good practices on the risk treatment, the double shift scenario shows an improvement among 25% to 88% in the variables of: health, labor motivation, burnout, service level and productivity; as well as in the variables of the organization associated to number of patients, nursing personnel and profit. Likewise, the single shift scenario with good practices improves in all the above-mentioned variables and generates stability on the variables of absenteeism and resignations. The best scenario is the single shift scenario with the application of good practices of risk treatment in comparison with the double shift scenario with good practices, which allows concluding that the good practices have a positive effect on the variables of nursing personnel and on those associated to the organization. Copyright© by the Universidad de Antioquia.

European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy.

PubMed

van Schaik, I N; Bouche, P; Illa, I; Léger, J-M; Van den Bergh, P; Cornblath, D R; Evers, E M A; Hadden, R D M; Hughes, R A C; Koski, C L; Nobile-Orazio, E; Pollard, J; Sommer, C; van Doorn, P A

2006-08-01

Several diagnostic criteria for multifocal motor neuropathy have been proposed in recent years and a beneficial effect of intravenous immunoglobulin (IVIg) and various other immunomodulatory drugs has been suggested in several trials and uncontrolled studies. The objectives were to prepare consensus guidelines on the definition, investigation and treatment of multifocal motor neuropathy. Disease experts and a patient representative considered references retrieved from MEDLINE and the Cochrane Library in July 2004 and prepared statements which were agreed in an iterative fashion. The Task Force agreed good practice points to define clinical and electrophysiological diagnostic criteria for multifocal motor neuropathy and investigations to be considered. The principal recommendations and good practice points were: (i) IVIg (2 g/kg given over 2-5 days) should be considered as the first line treatment (level A recommendation) when disability is sufficiently severe to warrant treatment. (ii) Corticosteroids are not recommended (good practice point). (iii) If initial treatment with IVIg is effective, repeated IVIg treatment should be considered (level C recommendation). The frequency of IVIg maintenance therapy should be guided by the individual response (good practice point). Typical treatment regimens are 1 g/kg every 2-4 weeks or 2 g/kg every 4-8 weeks (good practice point). (iv) If IVIg is not or not sufficiently effective then immunosuppressive treatment may be considered. Cyclophosphamide, ciclosporin, azathioprine, interferon beta1a, or rituximab are possible agents (good practice point). (v) Toxicity makes cyclophosphamide a less desirable option (good practice point).

7 CFR 1437.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (including ornamental fish), and floriculture, an environment in which everything that can practicably be..., as determined by CCC. Good farming practices means the cultural practices generally used for the crop... good farming practices. T-Yield means the yield which is based on the county expected yield of the crop...

Development of a new type of high pressure calorimetric cell, mechanically agitated and equipped with a dynamic pressure control system: Application to the characterization of gas hydrates

NASA Astrophysics Data System (ADS)

Plantier, F.; Marlin, L.; Missima, D.; Torré, J.-P.

2013-12-01

A novel prototype of calorimetric cell has been developed allowing experiments under pressure with an in situ agitation system and a dynamic control of the pressure inside the cell. The use of such a system opens a wide range of potential practical applications for determining properties of complex fluids in both pressurized and agitated conditions. The technical details of this prototype and its calibration procedure are described, and an application devoted to the determination of phase equilibrium and phase change enthalpy of gas hydrates is presented. Our results, obtained with a good precision and reproducibility, were found in fairly good agreement with those found in literature, illustrate the various interests to use this novel apparatus.

Significance of the Hygiene Charter towards different sectors in Hong Kong.

PubMed

Lee, A; Cheng, F F K; Yuen, H S K; Ho, M; Ngan, W P; Suen, Y P; Au, S M Y; Li, S N; Tso, C Y; Ng, P P Y; Wong, Y P; Keung, M W; Lo, A S C; Wong, W S; Siu, D C H; Yuen, W K; Mok, K K; Fung, W Y; Wong, K K

2004-01-01

The occurrence of SARS in March 2003 has resulted in an increased interest, worldwide in emerging infectious diseases. The SARS experience provided us a lesson on the importance of promoting hygienic practices among individuals and different working sectors. In Hong Kong, a voluntary organization called the UNITE proposed a Hygiene Charter which aimed at taking hygiene to new levels. This action has been supported by individuals and different sectors including the Personal and Family, Management, Buildings, Catering, Education, Finance and Commercial, Industrial, Medical and Health, Public Transportation, Social Welfare, Sports and Culture and Tourism. As promotion and maintenance of environmental health requires input from different sectors, the signing of the Hygiene Charter provides an opportunity for individuals and the public to show their pledge and commitment to good hygiene practices. As a result, with environment improvement and good infectious disease control measures, prevention of epidemics of infectious diseases is deemed to be possible.

Walk the Talk: Progress in Building a Supply Chain Security Culture

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hund, Gretchen

Pacific Northwest National Laboratory (PNNL) has engaged industry to “go beyond compliance” for over a decade in controlling and securing their supply chains to ensure their goods are not diverted to nuclear weapons programs. This work has focused on dual-use industries that manufacture products that can be used in both commercial applications and in the development of a nuclear weapon. The team encourages industry to self-regulate to reduce proliferation risks. As part of that work, PNNL interviewed numerous companies about their compliance practices to understand their business and to build awareness around best practices to ensure security of goods, technology,more » and information along their supply chains. From conducting this work, PNNL identified indicators that a company can adopt as part of its commitment to nonproliferation ideals with a focus on supply chain security.« less

Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

PubMed

Hyde, Tiffany D

2014-01-01

The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

[What everybody should know about good clinical practices].

PubMed

Osorio, Lyda

2015-01-01

An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

Practice guidelines for program evaluation in community-based rehabilitation.

PubMed

Grandisson, Marie; Hébert, Michèle; Thibeault, Rachel

2017-06-01

This paper proposes practice guidelines to evaluate community-based rehabilitation (CBR) programs. These were developed through a rigorous three-phase research process including a literature review on good practices in CBR program evaluation, a field study during which a South Africa CBR program was evaluated, and a Delphi study to generate consensus among a highly credible panel of CBR experts from a wide range of backgrounds and geographical areas. The 10 guidelines developed are summarized into a practice model highlighting key features of sound CBR program evaluation. They strongly indicate that sound CBR evaluations are those that give a voice and as much control as possible to the most affected groups, embrace the challenge of diversity, and foster use of evaluation processes and findings through a rigorous, collaborative and empowering approach. The practice guidelines should facilitate CBR evaluation decisions in respect to facilitating an evaluation process, using frameworks and designing methods. Implications for rehabilitation Ten practice guidelines provide guidance to facilitate sound community-based rehabilitation (CBR) program evaluation decisions. Key indications of good practice include: • being as participatory and empowering as possible; • ensuring that all, including the most affected, have a real opportunity to share their thoughts; • highly considering mixed methods and participatory tools; • adapting to fit evaluation context, local culture and language(s); • defining evaluation questions and reporting findings using shared CBR language when possible, which the framework offered may facilitate.

Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research. The Chemical Manufacturers Association's Epidemiology Task Group.

PubMed

1991-12-01

The Guidelines for Good Epidemiology Practices (GEPs) for Occupational and Environmental Epidemiologic Research address the conduct of studies generally undertaken to answer questions about human health in relationship to the work place or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemiologic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Practices propose minimum practices and procedures in the following areas: I. Organization and Personnel II. Facilities, Resource Commitment, and Contractors III. Protocol IV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance Although the Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they do provide a useful framework for ensuring that all research issues are adequately addressed. This framework is proposed as a first step in improving epidemiologic research practices through adherence to sound scientific research principles. Appendices provide an overview of standard operating procedures, a glossary of terms used in the Guidelines, and suggested references on occupational epidemiology methods.

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

PubMed

Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

2014-07-01

The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

PubMed Central

Abdellah, Abubaker; Noordin, Mohamed Ibrahim; Wan Ismail, Wan Azman

2013-01-01

Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines’ supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients’ safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized. PMID:25685037

Variable implementation of good practice recommendations for the assessment and management of UK children with neurodisability.

PubMed

Gray, L; Gibbs, J; Jolleff, N; Williams, J; McConachie, H; Parr, J R

2015-11-01

The aims of this study were to determine whether UK child development teams (CDTs) have implemented good practice recommendations for the co-ordinated assessment and support of children with neurodisability and to explore some of the factors associated with variations in good practice implementation. Surveys were sent to every UK CDT in 2009/2010. Responses about CDT provision and ways of working were compared with good practice recommendations from national policy documents and professional organizations. The extent to which CDTs in England and Wales met 11 selected good practice recommendations was scored; teams in Scotland and Northern Ireland were given a score out of 9 to reflect the optional use of the common assessment framework and early support materials in these countries. Responses were received from 225/240 (94%) UK CDTs. Thirty-seven per cent of CDTs in England and Wales had implemented nine or more of the 11 recommendations. Fifty-nine per cent of teams in Scotland and 78% of teams in Northern Ireland met between six and nine recommendations of good working practice. Higher levels of implementation of recommendations were found when the CDT had a Child Development Centre base and for teams who had received increased funding in the 5 years preceding the survey. There was considerable variability in the degree to which CDTs implemented good practice recommendations for the diagnosis and management of children with neurodisability. Evidence about child and parent satisfaction, and the effectiveness of CDT practices and provision, is required, so policymakers, healthcare commissioners and clinicians can provide the most appropriate services to children with neurodisability and their families. © 2015 John Wiley & Sons Ltd.

9 CFR 149.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... generates a written record documenting a pork production site's adherence to the required good production... production site for compliance with good production practices and other program requirements of the Trichinae... or higher, based on adherence to good production practices and other program requirements as provided...

9 CFR 149.1 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... generates a written record documenting a pork production site's adherence to the required good production... production site for compliance with good production practices and other program requirements of the Trichinae... or higher, based on adherence to good production practices and other program requirements as provided...

Diabetes and Diabetic Retinopathy: Knowledge, Attitude, Practice (KAP) among Diabetic Patients in A Tertiary Eye Care Centre

PubMed Central

Srinivasan, Nithin Keshav; John, Deepa; Rebekah, Grace; Kujur, Evon Selina; Paul, Padma

2017-01-01

Introduction Diabetic retinopathy is becoming an increasingly important cause of visual impairment in India. Many diabetic patients who come to our centre have undetected, advanced diabetic retinopathy. If diabetic retinopathy had been detected earlier in these patients, irreversible visual impairment could have been prevented. Aim To document Knowledge, Attitude and Practice (KAP) patterns of diabetic patients regarding diabetes and diabetic retinopathy, to determine association between them, and to identify barriers to compliance with follow up and treatment regimes. Materials and Methods This was a hospital-based, cross-sectional study, conducted at the Department of Ophthalmology at Christian Medical College, Vellore, Tamil Nadu, India, over a six-month period from June 2013 to November 2013. Two hundred and eighty eight diabetic patients, who fulfilled the eligibility criteria, were included in the study. KAP of patients was assessed using a 45-point, verbally administered questionnaire. Patients were placed in different categories, such as, ‘good/ poor’ knowledge, ‘positive/negative’ attitude and ‘good/poor’ practice. Data were analysed using Chi-square test and binary logistic regression, as appropriate. The proportion of patients with ‘good/poor’ knowledge, ‘positive/negative’ attitude and ‘good/poor’ practice, and the association between KAP were studied. Barriers to compliance with follow up/treatment regimes were identified. Results Out of the 288 patients in the study, 42% had good knowledge about diabetes, but only 4.5% had good knowledge about retinopathy. Good knowledge about diabetes was significantly associated with positive attitude towards diabetes and good practice patterns regarding retinopathy; awareness of retinopathy was also significantly associated with good practice. A total of 61.1% of patients did not have periodic eye examination; most common barrier identified was lack of awareness about the necessity for this (38.5%). Conclusion Good knowledge about the disease was significantly associated with positive attitude and good practice patterns. Knowledge about diabetic retinopathy was poor among the patients in our study. Lack of awareness concerning the need for screening for retinopathy was a major barrier to regular screening. There is an urgent need to educate diabetic patients about this potentially blinding complication of diabetes. PMID:28892947

Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death-Summary Report.

PubMed

Weiss, Matthew J; Hornby, Laura; Rochwerg, Bram; van Manen, Michael; Dhanani, Sonny; Sivarajan, V Ben; Appleby, Amber; Bennett, Mary; Buchman, Daniel; Farrell, Catherine; Goldberg, Aviva; Greenberg, Rebecca; Singh, Ram; Nakagawa, Thomas A; Witteman, William; Barter, Jill; Beck, Allon; Coughlin, Kevin; Conradi, Alf; Cupido, Cynthia; Dawson, Rosanne; Dipchand, Anne; Freed, Darren; Hornby, Karen; Langlois, Valerie; Mack, Cheryl; Mahoney, Meagan; Manhas, Deepak; Tomlinson, Christopher; Zavalkoff, Samara; Shemie, Sam D

2017-11-01

Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada. We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners. We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report. This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation.

The Utilization of the Seven Principles for Good Practices of Full-Time and Adjunct Faculty in Teaching Health & Science in Community Colleges

ERIC Educational Resources Information Center

Musaitif, Linda M.

2013-01-01

Purpose: The purpose of this study was to determine the degree to which undergraduate full-time and adjunct faculty members in the health and science programs at community colleges in Southern California utilize the seven principles of good practice as measured by the Faculty Inventory of the Seven Principles for Good Practice in Undergraduate…

Guide to good practices for operations and administration updates through required reading

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-12-01

The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, Conduct of Operations Requirements for DOE Facilities.'' (JDB)

Guide to good practices for operations and administration updates through required reading

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-12-01

The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, ``Conduct of Operations Requirements for DOE Facilities.`` (JDB)

CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis: a SUNFRAIL report.

PubMed

Bousquet, J; Onorato, G L; Bachert, C; Barbolini, M; Bedbrook, A; Bjermer, L; de Sousa, J Correia; Chavannes, N H; Cruz, A A; De Manuel Keenoy, E; Devillier, P; Fonseca, J; Hun, S; Kostka, T; Hellings, P W; Illario, M; Ivancevich, J C; Larenas-Linnemann, D; Millot-Keurinck, J; Ryan, D; Samolinski, B; Sheikh, A; Yorgancioglu, A; Agache, I; Arnavielhe, S; Bewick, M; Annesi-Maesano, I; Anto, J M; Bergmann, K C; Bindslev-Jensen, C; Bosnic-Anticevich, S; Bouchard, J; Caimmi, D P; Camargos, P; Canonica, G W; Cardona, V; Carriazo, A M; Cingi, C; Colgan, E; Custovic, A; Dahl, R; Demoly, P; De Vries, G; Fokkens, W J; Fontaine, J F; Gemicioğlu, B; Guldemond, N; Gutter, Z; Haahtela, T; Hellqvist-Dahl, B; Jares, E; Joos, G; Just, J; Khaltaev, N; Keil, T; Klimek, L; Kowalski, M L; Kull, I; Kuna, P; Kvedariene, V; Laune, D; Louis, R; Magnan, A; Malva, J; Mathieu-Dupas, E; Melén, E; Menditto, E; Morais-Almeida, M; Mösges, R; Mullol, J; Murray, R; Neffen, H; O'Hehir, R; Palkonen, S; Papadopoulos, N G; Passalacqua, G; Pépin, J L; Portejoie, F; Price, D; Pugin, B; Raciborski, F; Simons, F E R; Sova, M; Spranger, O; Stellato, C; Todo Bom, A; Tomazic, P V; Triggiani, M; Valero, A; Valovirta, E; VandenPlas, O; Valiulis, A; van Eerd, M; Ventura, M T; Wickman, M; Young, I; Zuberbier, T; Zurkuhlen, A; Senn, A

2017-01-01

A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care pathways using emerging technologies with real life data in rhinitis and asthma multi-morbidity. The European Union Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) has developed a checklist of 28 items for the evaluation of Good Practices. SUNFRAIL (Reference Sites Network for Prevention and Care of Frailty and Chronic Conditions in community dwelling persons of EU Countries), a European Union project, assessed whether MASK is in line with the 28 items of JA-CHRODIS. A short summary was proposed for each item and 18 experts, all members of ARIA and SUNFRAIL from 12 countries, assessed the 28 items using a Survey Monkey-based questionnaire. A visual analogue scale (VAS) from 0 (strongly disagree) to 100 (strongly agree) was used. Agreement equal or over 75% was observed for 14 items (50%). MASK is following the JA-CHRODIS recommendations for the evaluation of Good Practices.

Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

PubMed

Sweet, J; Wilson, J; Pugsley, L; Schofield, M

2008-12-13

This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.

Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.

PubMed

Berger, Marc L; Sox, Harold; Willke, Richard J; Brixner, Diana L; Eichler, Hans-Georg; Goettsch, Wim; Madigan, David; Makady, Amr; Schneeweiss, Sebastian; Tarricone, Rosanna; Wang, Shirley V; Watkins, John; Daniel Mullins, C

2017-09-01

Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders. © 2017 The Authors. Pharmacoepidemiology & Drug Safety published by John Wiley & Sons Ltd.

76 FR 24291 - Proposed National Marketing Agreement Regulating Leafy Green Vegetables; Recommended Decision and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

... Practices (GAPs) and Good Manufacturing Practices (GMPs), and United States Department of Agriculture (USDA) Good Handling Practices (GHPs). The program would be voluntary, and cover both United States and... referred to as the ``Act'', and the applicable rules of practice and procedure governing the formulation of...

Flexible body control using neural networks

NASA Technical Reports Server (NTRS)

Mccullough, Claire L.

1992-01-01

Progress is reported on the control of Control Structures Interaction suitcase demonstrator (a flexible structure) using neural networks and fuzzy logic. It is concluded that while control by neural nets alone (i.e., allowing the net to design a controller with no human intervention) has yielded less than optimal results, the neural net trained to emulate the existing fuzzy logic controller does produce acceptible system responses for the initial conditions examined. Also, a neural net was found to be very successful in performing the emulation step necessary for the anticipatory fuzzy controller for the CSI suitcase demonstrator. The fuzzy neural hybrid, which exhibits good robustness and noise rejection properties, shows promise as a controller for practical flexible systems, and should be further evaluated.

Security Engineering and Educational Initiatives for Critical Information Infrastructures

DTIC Science & Technology

2013-06-01

standard for cryptographic protection of SCADA communications. The United Kingdom’s National Infrastructure Security Co-ordination Centre (NISCC...has released a good practice guide on firewall deployment for SCADA systems and process control networks [17]. Meanwhile, National Institute for ...report. APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED 18 The SCADA gateway collects the data gathered by sensors, translates them from

A hybrid brain-computer interface based on the fusion of electroencephalographic and electromyographic activities

NASA Astrophysics Data System (ADS)

Leeb, Robert; Sagha, Hesam; Chavarriaga, Ricardo; Millán, José del R.

2011-04-01

Hybrid brain-computer interfaces (BCIs) are representing a recent approach to develop practical BCIs. In such a system disabled users are able to use all their remaining functionalities as control possibilities in parallel with the BCI. Sometimes these people have residual activity of their muscles. Therefore, in the presented hybrid BCI framework we want to explore the parallel usage of electroencephalographic (EEG) and electromyographic (EMG) activity, whereby the control abilities of both channels are fused. Results showed that the participants could achieve a good control of their hybrid BCI independently of their level of muscular fatigue. Thereby the multimodal fusion approach of muscular and brain activity yielded better and more stable performance compared to the single conditions. Even in the case of an increasing muscular fatigue a good control (moderate and graceful degradation of the performance compared to the non-fatigued case) and a smooth handover could be achieved. Therefore, such systems allow the users a very reliable hybrid BCI control although they are getting more and more exhausted or fatigued during the day.

Effectiveness of prerequisites and the HACCP plan in the control of microbial contamination in ice cream and cheese companies.

PubMed

Domenech, Eva; Amorós, José Antonio; Escriche, Isabel

2013-03-01

In food safety, implementation of prerequisites and application of Hazard Analysis and Critical Control Points (HACCP) guarantee the control of processes, and microbiological criteria permit validation of their effectiveness. With these aims in mind, this article presents the results obtained by the official control carried out by the Valencian administration in ice cream and cheese companies, located in the Xativa/Ontinyente area (Valencian region, Spain) in the period between 2005 and 2010. The audits of Good Hygienic Practices (GHP) and HACCP show that "Structure & Design" followed by "Hygiene & Cleaning" and "Traceability" were the evaluated items with most nonconformities. Pathogenic microorganisms were not found in any of the final products analyzed. Microorganism indicators of unhygienic conditions were present in 100% of the analyses; however, 87.98% of them had low levels, which did not exceed the microbiological criteria. These results highlight the general good effectiveness of the safety management systems implemented and emphasize that companies and official control must continue working in order to guarantee the consumers' welfare.

Feasibility and effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial.

PubMed

Armour, Carol L; Reddel, Helen K; LeMay, Kate S; Saini, Bandana; Smith, Lorraine D; Bosnic-Anticevich, Sinthia Z; Song, Yun Ju Christine; Alles, M Chehani; Burton, Deborah L; Emmerton, Lynne; Stewart, Kay; Krass, Ines

2013-04-01

To test the feasibility, effectiveness, and sustainability of a pharmacy asthma service in primary care. A pragmatic cluster randomized trial in community pharmacies in four Australian states/territories in 2009. Specially trained pharmacists were randomized to deliver an asthma service in two groups, providing three versus four consultations over 6 months. People with poorly controlled asthma or no recent asthma review were included. Follow-up for 12 months after service completion occurred in 30% of randomly selected completing patients. Outcomes included change in asthma control (poor and fair/good) and Asthma Control Questionnaire (ACQ) score, inhaler technique, quality of life, perceived control, adherence, asthma knowledge, and asthma action plan ownership. Ninety-six pharmacists enrolled 570 patients, with 398 (70%) completing. Asthma control significantly improved with both the three- and four-visit service, with no significant difference between groups (good/fair control 29% and 21% at baseline, 61% and 59% at end, p = .791). Significant improvements were also evident in the ACQ (mean change 0.56), inhaler technique (17-33% correct baseline, 57-72% end), asthma action plan ownership (19% baseline, 56% end), quality of life, adherence, perceived control, and asthma knowledge, with no significant difference between groups for any variable. Outcomes were sustained at 12 months post-service. The pharmacy asthma service delivered clinically important improvements in both a three-visit and four-visit service. Pharmacists were able to recruit and deliver the service with minimal intervention, suggesting it is practical to implement in practice. The three-visit service would be feasible and effective to implement, with a review at 12 months.

Intertester and intratester reliability of movement control tests on the hip for patients with hip osteoarthritis.

PubMed

Lenzlinger-Asprion, Rahel; Keller, Niculina; Meichtry, André; Luomajoki, Hannu

2017-01-31

Hip joint complaints are a problem associated with increasing age and impair the mobility of a large section of the elderly population. Reliable and valid tests are necessary for a thorough investigation of a joint. A fundamental function of the hip joint is movement control and a test of this function forms a part of the standard examination. Until now there have been few scientific studies which specifically investigate the reliability of measurement tests of movement control of the hip joint. The aim of this study was to examine the intratester and intertester reliability of the movement control tests of the hip joint which are in use in current clinical practice. Sixteen participants with hip joint complaints and 14 without hip joint impairment were recruited. All participants performed five active movement control tests for the hip joint and were video filmed whilst performing these tests. These films formed the basis for the evaluation and were assessed by two independent physiotherapists. For the intertester and intratester reliability calculations specially set weighted kappa values and the calculated percentages were used. The intertester reliability of the five examined movement control tests of the hip joint showed good to almost perfect values (weighted kappa (wk) = 0.56-0.87). The intratester reliability of the more experienced evaluator A was better in regards to the less experienced evaluator B (average wk = 0.62 vs 0.38). The visual evaluation of movement control tests of the hip joint is especially reliable when carried out by an experienced evaluator. 4 out of 5 tests also showed good results for intertester reliability and support their use in clinical practice.

Fine-motor skills testing and prediction of endovascular performance.

PubMed

Bech, Bo; Lönn, Lars; Schroeder, Torben V; Ringsted, Charlotte

2013-12-01

Performing endovascular procedures requires good control of fine-motor digital movements and hand-eye coordination. Objective assessment of such skills is difficult. Trainees acquire control of catheter/wire movements at various paces. However, little is known to what extent talent plays for novice candidates at entry to practice. To study the association between performance in a novel aptitude test of fine-motor skills and performance in simulated procedures. The test was based on manual course-tracking using a proprietary hand-operated roller-bar device coupled to a personal computer with monitor view rotation. A total of 40 test repetitions were conducted separately with each hand. Test scores were correlated with simulator performance. Group A (n = 14), clinicians with various levels of endovascular experience, performed a simulated procedure of contralateral iliac artery stenting. Group B (n = 19), medical students, performed 10 repetitions of crossing a challenging aortic bifurcation in a simulator. The test score differed markedly between the individuals in both groups, in particular with the non-dominant hand. Group A: the test score with the non-dominant hand correlated significantly with simulator performance assessed with the global rating scale SAVE (R = -0.69, P = 0.007). There was no association observed from performances with the dominant hand. Group B: there was no significant association between the test score and endovascular skills acquisition neither with the dominant nor with the non-dominant hand. Clinicians with increasing levels of endovascular technical experience had developed good fine-motor control of the non-dominant hand, in particular, that was associated with good procedural performance in the simulator. The aptitude test did not predict endovascular skills acquisition among medical students, thus, cannot be suggested for selection of novice candidates. Procedural experience and practice probably supplant the influence of innate abilities (talent) over time.

The Application of Linear and Nonlinear Water Tanks Case Study in Teaching of Process Control

NASA Astrophysics Data System (ADS)

Li, Xiangshun; Li, Zhiang

2018-02-01

In the traditional process control teaching, the importance of passing knowledge is emphasized while the development of creative and practical abilities of students is ignored. Traditional teaching methods are not very helpful to breed a good engineer. Case teaching is a very useful way to improve students’ innovative and practical abilities. In the traditional case teaching, knowledge points are taught separately based on different examples or no examples, thus it is very hard to setup the whole knowledge structure. Though all the knowledge is learned, how to use the knowledge to solve engineering problems keeps challenging for students. In this paper, the linear and nonlinear tanks are taken as illustrative examples which involves several knowledge points of process control. The application method of each knowledge point is discussed in detail and simulated. I believe the case-based study will be helpful for students.

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2012 CFR

2012-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2013 CFR

2013-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2011 CFR

2011-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2010 CFR

2010-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

Documentation: Records and Reports.

PubMed

Akers, Michael J

2017-01-01

This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them. For 503a pharmacies, one can see the development and modification of Good Manufacturing Practice and even observe changes as they are occurring in 503a documentation requirements and anticipate that changes will probably continue to occur. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Common meanings of good and bad sleep in a healthy population sample.

PubMed

Dickerson, Suzanne S; Klingman, Karen J; Jungquist, Carla R

2016-09-01

The study's purpose was to understand the common meanings and shared practices related to good and bad sleep from narratives of a sample of healthy participants. Interpretive phenomenology was the approach to analyze narratives of the participants' everyday experiences with sleep. Participants were interviewed and asked to describe typical good and bad nights' sleep, what contributes to their sleep experience, and the importance of sleep in their lives. Team interpretations of narratives identified common themes by consensus. Medium sized city in New York State (upper west region). A sample of 30 healthy participants were from a parent study (n=300) on testing the sleep questions from the Behavioral Risk Factor Surveillance System from the Centers for Disease Control and Prevention. Interpretations of good and bad sleep. Participants described similar experiences of good and bad sleep often directly related to their ability to schedule time to sleep, fall asleep, and maintain sleep. Worrying about life stresses and interruptions prevented participants from falling asleep and staying asleep. Yet, based on current life priorities (socializers, family work focused, and optimum health seekers), they had differing values related to seeking sleep opportunities and strategizing to overcome challenges. The participants' priorities reflected the context of their main concerns and stresses in life that influenced the importance given to promoting sleep opportunities. Public health messages tailored to life priorities could be developed to promote healthy sleep practices. Copyright © 2016 National Sleep Foundation. Published by Elsevier Inc. All rights reserved.

What Is "Good" Mentoring? Understanding Mentoring Practices of Teacher Induction through Case Studies of Finland and Australia

ERIC Educational Resources Information Center

Pennanen, Matti; Bristol, Laurette; Wilkinson, Jane; Heikkinen, Hannu L. T.

2016-01-01

Mentoring is a practice widely utilised to support new teachers. However, in locally formed systems, the practice of mentoring is conditioned by traditions and arrangements specific to the site. To understand "good" mentoring, these local arrangements cannot be ignored. In this article, the theory of practice architectures is employed to…

Effects of physical and sporting activities on balance control in elderly people

PubMed Central

Perrin, P. P.; Gauchard, G. C.; Perrot, C.; Jeandel, C.

1999-01-01

OBJECTIVE: Balance disorders increase with aging and raise the risk of accidental falls in the elderly. It has been suggested that the practice of physical and sporting activities (PSA) efficiently counteracts these age related disorders, reducing the risk of falling significantly. METHODS: This study, principally based on a period during which the subjects were engaged in PSA, included 65 healthy subjects, aged over 60, who were living at home. Three series of posturographic tests (static, dynamic with a single and fast upward tilt, and dynamic with slow sinusoidal oscillations) analysing the centre of foot pressure displacements or electromyographic responses were conducted to determine the effects of PSA practice on balance control. RESULTS: The major variables of postural control were best in subjects who had always practised PSA (AA group). Those who did not take part in PSA at all (II group) had the worst postural performances, whatever the test. Subjects having lately begun PSA practice (IA group) had good postural performances, close to those of the AA group, whereas the subjects who had stopped the practice of PSA at an early age (AI group) did not perform as well. Overall, the postural control in the group studied decreased in the order AA > IA > AI > II. CONCLUSIONS: The period during which PSA are practised seems to be of major importance, having a positive bearing on postural control. It seems that recent periods of practice have greater beneficial effects on the subject's postural stability than PSA practice only at an early age. These data are compatible with the fact that PSA are extremely useful for elderly people even if it has not been a lifelong habit. 


 PMID:10205695

[Preliminary studies on critical control point of traceability system in wolfberry].

PubMed

Liu, Sai; Xu, Chang-Qing; Li, Jian-Ling; Lin, Chen; Xu, Rong; Qiao, Hai-Li; Guo, Kun; Chen, Jun

2016-07-01

As a traditional Chinese medicine, wolfberry (Lycium barbarum) has a long cultivation history and a good industrial development foundation. With the development of wolfberry production, the expansion of cultivation area and the increased attention of governments and consumers on food safety, the quality and safety requirement of wolfberry is higher demanded. The quality tracing and traceability system of production entire processes is the important technology tools to protect the wolfberry safety, and to maintain sustained and healthy development of the wolfberry industry. Thus, this article analyzed the wolfberry quality management from the actual situation, the safety hazard sources were discussed according to the HACCP (hazard analysis and critical control point) and GAP (good agricultural practice for Chinese crude drugs), and to provide a reference for the traceability system of wolfberry. Copyright© by the Chinese Pharmaceutical Association.

Design of sewage treatment system by applying fuzzy adaptive PID controller

NASA Astrophysics Data System (ADS)

Jin, Liang-Ping; Li, Hong-Chan

2013-03-01

In the sewage treatment system, the dissolved oxygen concentration control, due to its nonlinear, time-varying, large time delay and uncertainty, is difficult to establish the exact mathematical model. While the conventional PID controller only works with good linear not far from its operating point, it is difficult to realize the system control when the operating point far off. In order to solve the above problems, the paper proposed a method which combine fuzzy control with PID methods and designed a fuzzy adaptive PID controller based on S7-300 PLC .It employs fuzzy inference method to achieve the online tuning for PID parameters. The control algorithm by simulation and practical application show that the system has stronger robustness and better adaptability.