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...

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...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... § 184.1(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...

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.

76 FR 55067 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-06

... Pharmaceutical Current Good Manufacturing Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Good Manufacturing Practice--(OMB Control Number 0910-0563)--Extension The guidance is intended to... products, on how to resolve disputes of scientific and technical issues relating to current good...

76 FR 2123 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

...; Current Good Manufacturing Practice Quality System Regulation AGENCY: Food and Drug Administration, HHS... information entitled ``Current Good Manufacturing Practice Quality System Regulation'' has been approved by...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 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...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 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...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 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...

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...

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…

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...

75 FR 40840 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-14

... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either... in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111...

21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

Code of Federal Regulations, 2014 CFR

2014-04-01

... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

Code of Federal Regulations, 2013 CFR

2013-04-01

... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

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...

77 FR 23732 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-20

...; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ``Lookback'' AGENCY: Food and Drug Administration, HHS... information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood...

21 CFR 113.5 - 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. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 113.5 - 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. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 113.5 - 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. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 113.5 - 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. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

21 CFR 184.1139 - Ammonium hydroxide.

Code of Federal Regulations, 2010 CFR

2010-04-01

... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

21 CFR 184.1139 - Ammonium hydroxide.

Code of Federal Regulations, 2011 CFR

2011-04-01

... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

21 CFR 184.1139 - Ammonium hydroxide.

Code of Federal Regulations, 2012 CFR

2012-04-01

... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

21 CFR 184.1139 - Ammonium hydroxide.

Code of Federal Regulations, 2013 CFR

2013-04-01

... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

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...

21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 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 supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 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 supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 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 supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 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 supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

78 FR 64425 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 225, 500, 507, and 579 [Docket No. FDA-2011-N-0922] Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Food for Animals; Public Meeting on Proposed Rule AGENCY: Food and...

Evaluation Instruments and Good Practices in Online Education

ERIC Educational Resources Information Center

Baldwin, Sally J.; Trespalacios, Jesús

2017-01-01

Chickering and Gamson's (1987) "Seven Principles for Good Practice in Undergraduate Education" offers extensively researched and validated tenets for best practices in higher education. After a review of the literature, twenty-eight evaluation instruments currently used to design and review online courses in higher education institutions…

21 CFR 184.1143 - Ammonium sulfate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... chapter, and processing aid as defined in § 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.15 percent for baked goods as defined in...

Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility

NASA Technical Reports Server (NTRS)

Hirsch, David; Williams, James H.

2005-01-01

An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.

Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule.

PubMed

2007-06-25

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

21 CFR 184.1676 - Pyridoxine hydrochloride.

Code of Federal Regulations, 2011 CFR

2011-04-01

... hydrochloride that is prepared by chemical synthesis. (b) The ingredient meets the specifications of the Food... manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in... exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter...

21 CFR 129.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... drinking water are in conformance with or are operated or administered in conformity with good manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1...

On the Need for Practical Formal Methods

DTIC Science & Technology

1998-01-01

additional research and engineering that is needed to make the current set of formal methods more practical. To illustrate the ideas, I present several exam ...either a good violin or a highly talented violinist. Light-weight techniques o er software developers good violins . A user need not be a talented

VET Providers Planning to Deliver Degrees: Good Practice Guide

ERIC Educational Resources Information Center

National Centre for Vocational Education Research (NCVER), 2015

2015-01-01

This good practice guide is intended to assist public and private registered training organisations (RTOs) planning to commence higher education (HE) delivery. The guide is based on research undertaken by Victor Callan and Kaye Bowman, who completed case studies with six providers currently delivering higher education qualifications in addition to…

Guide of good practices for occupational radiological protection in plutonium facilities

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

NONE

1998-06-01

This Technical Standard (TS) does not contain any new requirements. Its purpose is to provide guides to good practice, update existing reference material, and discuss practical lessons learned relevant to the safe handling of plutonium. the technical rationale is given to allow US Department of Energy (DOE) health physicists to adapt the recommendations to similar situations throughout the DOE complex. Generally, DOE contractor health physicists will be responsible to implement radiation protection activities at DOE facilities and DOE health physicists will be responsible for oversight of those activities. This guidance is meant to be useful for both efforts. This TSmore » replaces PNL-6534, Health Physics Manual of Good Practices for Plutonium Facilities, by providing more complete and current information and by emphasizing the situations that are typical of DOE`s current plutonium operations; safe storage, decontamination, and decommissioning (environmental restoration); and weapons disassembly.« less

Knowledge Gained from Good Agricultural Practices Courses for Iowa Growers

ERIC Educational Resources Information Center

Shaw, Angela; Strohbehn, Catherine; Naeve, Linda; Domoto, Paul; Wilson, Lester

2015-01-01

Good Agricultural Practices (GAP) educational courses provide produce growers with the fundamental information for producing and processing safe produce. To determine the effectiveness of the current 7-hour GAP course provided in Iowa, growers were surveyed before and 7-14 days after the course to determine changes in knowledge and opinions.…

21 CFR 184.1069 - Malic acid.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L... ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of...

21 CFR 184.1069 - Malic acid.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L... ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of...

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.

Singing in Primary Schools: Case Studies of Good Practice in Whole Class Vocal Tuition

ERIC Educational Resources Information Center

Lamont, Alexandra; Daubney, Alison; Spruce, Gary

2012-01-01

Within the context of British initiatives in music education such as the Wider Opportunities programme in England and the recommendations of the Music Manifesto emphasising the importance of singing in primary schools, the current paper explores examples of good practice in whole-class vocal tuition. The research included seven different primary…

21 CFR 184.1095 - Sulfuric acid.

Code of Federal Regulations, 2010 CFR

2010-04-01

... § 170.3(o)(23) of this chapter and processing aid as defined in § 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.014 percent for...

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.

TESOL: Current Problems and Classroom Practices.

ERIC Educational Resources Information Center

Wardhaugh, Ronald

This paper attempts to "bridge the gap between the practical orientation of teachers and the theoretical concerns that should underlie practice," Discussed in turn are language, psychology, and pedagogical philosophy. An adequate knowledge of these areas is essential to good classroom practices; every bad practice is evidence of some weakness in…

Articulating current service development practices: a qualitative analysis of eleven mental health projects

PubMed Central

2014-01-01

Background The utilisation of good design practices in the development of complex health services is essential to improving quality. Healthcare organisations, however, are often seriously out of step with modern design thinking and practice. As a starting point to encourage the uptake of good design practices, it is important to understand the context of their intended use. This study aims to do that by articulating current health service development practices. Methods Eleven service development projects carried out in a large mental health service were investigated through in-depth interviews with six operation managers. The critical decision method in conjunction with diagrammatic elicitation was used to capture descriptions of these projects. Stage-gate design models were then formed to visually articulate, classify and characterise different service development practices. Results Projects were grouped into three categories according to design process patterns: new service introduction and service integration; service improvement; service closure. Three common design stages: problem exploration, idea generation and solution evaluation - were then compared across the design process patterns. Consistent across projects were a top-down, policy-driven approach to exploration, underexploited idea generation and implementation-based evaluation. Conclusions This study provides insight into where and how good design practices can contribute to the improvement of current service development practices. Specifically, the following suggestions for future service development practices are made: genuine user needs analysis for exploration; divergent thinking and innovative culture for idea generation; and fail-safe evaluation prior to implementation. Better training for managers through partnership working with design experts and researchers could be beneficial. PMID:24438471

Articulating current service development practices: a qualitative analysis of eleven mental health projects.

PubMed

Jun, Gyuchan Thomas; Morrison, Cecily; Clarkson, P John

2014-01-17

The utilisation of good design practices in the development of complex health services is essential to improving quality. Healthcare organisations, however, are often seriously out of step with modern design thinking and practice. As a starting point to encourage the uptake of good design practices, it is important to understand the context of their intended use. This study aims to do that by articulating current health service development practices. Eleven service development projects carried out in a large mental health service were investigated through in-depth interviews with six operation managers. The critical decision method in conjunction with diagrammatic elicitation was used to capture descriptions of these projects. Stage-gate design models were then formed to visually articulate, classify and characterise different service development practices. Projects were grouped into three categories according to design process patterns: new service introduction and service integration; service improvement; service closure. Three common design stages: problem exploration, idea generation and solution evaluation - were then compared across the design process patterns. Consistent across projects were a top-down, policy-driven approach to exploration, underexploited idea generation and implementation-based evaluation. This study provides insight into where and how good design practices can contribute to the improvement of current service development practices. Specifically, the following suggestions for future service development practices are made: genuine user needs analysis for exploration; divergent thinking and innovative culture for idea generation; and fail-safe evaluation prior to implementation. Better training for managers through partnership working with design experts and researchers could be beneficial.

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.

21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

Code of Federal Regulations, 2014 CFR

2014-04-01

... limitation other 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... § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as defined in § 170.3(n)(31...

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.

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.

21 CFR 184.1670 - Propylparaben.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-hydroxybenzoate. It is produced by the n-propanol esterification of p-hydroxybenzoic acid in the presence of... practices. Current good manufacturing practice results in a maximum level of 0.1 percent in food. (e) Prior...

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.

Advancing practice relating to SEA alternatives

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

González, Ainhoa, E-mail: agonzal@tcd.ie; Thérivel, Riki, E-mail: levett-therivel@phonecoop.coop; Fry, John, E-mail: john.fry@ucd.ie

Developing and assessing alternatives is a key and central stage to Strategic Environmental Assessment (SEA). However, research has repeatedly reported this stage as one of the most poorly undertaken aspects of the SEA process. Current practice limitations include belated consideration of reasonable alternatives, narrow scope of alternatives that often include unrealistic or retrofitted options, limited stakeholder and public involvement in their identification, assessment and selection, lack of systematic approaches to their assessment and comparison, and inadequate reporting of the ‘storyline’ on how they were identified, what the potential impacts are and why the preferred alternative was selected. These issues havemore » resulted in objections and judicial reviews. On the positive side, a number of good practice case studies enable extraction of key lessons and formulation of a set of general recommendations to advance practice in SEA alternatives. In this paper, practical guidance on the identification and development of alternatives, their assessment and comparison, selection of the preferred option, and documentation of the process and the reasons for selection is provided and discussed to frame good practice approaches. - Highlights: • Alternatives are one of the most poorly completed aspects of Strategic Environmental Assessment. • Current practice limitations need to be addressed to enhance SEA effectiveness. • A set of recommendations are extracted from good practice case studies. • These recommendations can be applied across jurisdictions and sectors and tailored as necessary.« less

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.

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

Acting, Accidents and Performativity: Challenging the Hegemonic Good Student in Secondary Schools

ERIC Educational Resources Information Center

Thompson, Greg

2010-01-01

Current educational practice tends to ascribe a limiting vision of the good student as one who is well behaved, performs well in assessments and demonstrates values in keeping with dominant expectations. This paper argues that this vision of the good student is antithetical to the lived experience of students as they negotiate their positionality…

78 FR 24691 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' that appeared in... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' with a 120-day...

Good cell culture practices &in vitro toxicology.

PubMed

Eskes, Chantra; Boström, Ann-Charlotte; Bowe, Gerhard; Coecke, Sandra; Hartung, Thomas; Hendriks, Giel; Pamies, David; Piton, Alain; Rovida, Costanza

2017-12-01

Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method. Copyright © 2017 Elsevier Ltd. All rights reserved.

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...

Teacher Preparation Practices in Kenya and the 21st Century Learning: A Moral Obligation

ERIC Educational Resources Information Center

Kafwa, Nabwire Opata; Gaudience, Obondo; Kisaka, Sella Terrie

2015-01-01

Teacher preparation practices are indices used to measure quality teacher besides other variables. Whereas the current teacher preparation is test scores based inclining to cognitive knowledge, a good teacher preparation practices is a holistic development in nature oriented towards character, skills and knowledge. To embed teacher preparation in…

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.
.

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.

76 FR 28045 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for... Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been...

Developing a tool to support diagnostic delivery of dementia.

PubMed

Bennett, Claire E; De Boos, Danielle; Moghaddam, Nima G

2018-01-01

It is increasingly recognised that there are challenges affecting the current delivery of dementia diagnoses. Steps are required to address this. Current good practice guidelines provide insufficient direction and interventions from other healthcare settings do not appear to fully translate to dementia care settings. This project has taken a sequential two-phase design to developing a tool specific to dementia diagnostic delivery. Interviews with 14 participants explored good diagnostic delivery. Thematic analysis produced key themes (overcoming barriers, navigation of multiple journeys and completing overt and covert tasks) that were used to inform the design of a tool for use by clinicians, patients and companions. The tool was evaluated for acceptability in focused group discussions with 13 participants, which indicated a desire to use the tool and that it could encourage good practice. Adaptations were highlighted and incorporated to improve acceptability. Future research is now required to further evaluate the tool.

What is Good University Financial Management?

ERIC Educational Resources Information Center

Taylor, Mark P.

2013-01-01

In the current and foreseeable harsh UK higher education environment, aspiring to best-practice financial management will be key to ensuring the prosperity--and indeed the survival--of any university. In this article I argue that good university financial management should provide stability to the institution, allow for investment as well as…

21 CFR 184.1560 - Ox bile extract.

Code of Federal Regulations, 2010 CFR

2010-04-01

... known as purified oxgall or sodium choleate, is a yellowish green, soft solid, with a partly sweet... evaporating the alcohol extract of concentrated bile. (b) Food-grade ox bile extract shall meet the... with § 184.1(b)(1) at levels not to exceed good manufacturing practice. Current good manufacturing...

77 FR 16158 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

... ``cut'' from a sheet or roll of labels--is used. Persistent problems with drug product mislabeling and... believe that development and use of advanced code scanning equipment has made many current electronic... and other advanced scanning techniques have made current electronic systems reliable to the 100...

Rethinking Nutrition: Connecting Science and Practice in Early Childhood Settings, Revised Edition

ERIC Educational Resources Information Center

Nitzke, Susan; Riley, Dave; Ramminger, Ann; Jacobs, Georgine

2015-01-01

Nutrition has vital and long-lasting effects on children's development. Good nutrition helps children learn better and promotes lifelong healthy eating habits. Connecting current scientific research with best practices, "Rethinking Nutrition" provides information to help you meet and understand children's nutritional and developmental…

Characterization and development of truck load spectra and growth factors for current and future pavement design practices in Louisiana.

DOT National Transportation Integrated Search

2011-07-01

For pavement design practices, several factors must be considered to ensure good pavement performance over the anticipated life cycle. : Such factors include, but are not limited to, the type of paving materials, traffic loading characteristics, prev...

Managing Productive Schools: Toward an Ecology.

ERIC Educational Resources Information Center

Snyder, Karolyn J.; Anderson, Robert H.

Intended for use by graduate students in educational administration and supervision as well as by practicing school administrators, this book is a guide to the most effective practices surrounding the school principalship. Ideas in the book reflect current views of good management, including systems approaches, participative and collaborative…

Standards of Practice in Continuing Education: A Status Study. Research Report: CCEU Project for the Development of Standards and Criteria for Good Practice in Continuing Education.

ERIC Educational Resources Information Center

House, Richard M.

A major purpose of this study was to determine the attitudes toward standards of practice and the nature and scope of standards of practice as they currently exist in governmental agencies, professional associations and licensing agencies, business and industry, health-related organizations, and colleges and universities. A second purpose was to…

21 CFR 184.1676 - Pyridoxine hydrochloride.

Code of Federal Regulations, 2014 CFR

2014-04-01

... exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter...)(31) of this chapter; plant protein products as defined in § 170.3(n)(33) of this chapter; and snack... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Pyridoxine hydrochloride. 184.1676 Section 184...

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...

21 CFR 184.1315 - Ferrous sulfate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... as pale, bluish-green crystals or granules. Progressive heating of ferrous sulfate heptahydrate...) of this chapter, with no limitation other than current good manufacturing practice. The ingredients...

21 CFR 184.1139 - Ammonium hydroxide.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler water additive complying with... manufacturing practice. The ingredient may also be used as a boiler water additive at levels not to exceed... limitation other than current good manufacturing practice. The affirmation of this ingredient as generally...

21 CFR 211.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... foods are manufactured, processed, packed, or held under current good manufacturing practice. [43 FR... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND... MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. Link to an amendment...

76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

... Cells, Tissues, and Cellular and Tissue-Based Products; Availability AGENCY: Food and Drug... Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated... Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and...

Professionalization, Ethics, and Fidelity to an Evaluation Ethos

ERIC Educational Resources Information Center

Schwandt, Thomas A.

2017-01-01

Current discussion of the professionalization of the practice of evaluation is focused on matters of competencies and credentialing and largely overlooks several significant issues. These include conflating professionalizing the practice with promoting the value of evaluation as a social good, assuming there is widespread agreement on what the…

21 CFR 110.40 - Equipment and utensils.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD... manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and...

21 CFR 110.40 - Equipment and utensils.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD... manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and...

21 CFR 110.40 - Equipment and utensils.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD... manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and...

21 CFR 110.40 - Equipment and utensils.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD... manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and...

21 CFR 110.40 - Equipment and utensils.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD... manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and...

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 211.188 - 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 211.105 - 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 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...

Reflections on Teaching and Research: Two Inseparable Components in Higher Education

ERIC Educational Resources Information Center

Chan Fong Yee, Fanny

2014-01-01

Teaching and research are two inseparable components in higher education. There are continuous debates about the relationship between the two. Does good teaching always lead to good research, and vice versa? This paper critically examines the impact of current policy on the two academic practices and discusses how it shapes one's professional…

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2013 CFR

2013-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2012 CFR

2012-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2010 CFR

2010-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 886.1665 - Ophthalmic rotary prism.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation... also exempt from the current good manufacturing practice requirements of the quality system regulation...

21 CFR 173.228 - Ethyl acetate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION (CONTINUED) SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION Solvents... with current good manufacturing practice as a solvent in the decaffeination of coffee and tea. [47 FR...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

Effective Superintendent-School Board Practices: Strategies for Developing and Maintaining Good Relationships with Your Board

ERIC Educational Resources Information Center

Townsend, Rene S.; Johnston, Gloria L.; Gross, Gwen E.; Lynch, Peggy; Garcy, Lorraine M.; Roberts, Benita B.; Novotney, Patricia B.

2006-01-01

Foster a strong superintendent-school board relationship centered on quality teaching and learning! This book helps current and future superintendents and school board members develop an effective governance team that prioritizes quality teaching and learning. Designed for practicing and aspiring superintendents and school board members, this…

Collective Genius: Bridging the Gaps among Research, Innovation and Practice

ERIC Educational Resources Information Center

O'Hair, Mary John

2011-01-01

In this article, the author focuses on bridging the gaps among research, innovation, and practice. First, the author reflects on historical perspectives involving the use of research to improve education and serve the public good. Second, the author explores the current climate as reflected by three national reports highlighting future roles of…

Recommended Practice on Lighting for Educational Facilities.

ERIC Educational Resources Information Center

Illuminating Engineering Society, New York, NY.

The aims of this document are: (1) to enable school and college administrators to brief their architects on appropriate provision of lighting, and (2) to enable lighting designers to check that the criteria they apply are consistent with good current practice. The scope is restricted to learning and study activities and associated circulation.…

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...

Institutional Regimes and Induced Dependency in Homes for the Aged.

ERIC Educational Resources Information Center

Booth, Tim

1986-01-01

Reports effects of institutional regimes on levels of dependency among residents of public homes for the elderly in England. Differences in management practices and caring routines did not affect the creation or reduction of dependency among residents. Questions the rationale that informs some current notions of good practice in residential work.…

21 CFR 874.1500 - Gustometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 874.1500 - Gustometer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 211.111 - Time limitations on production.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and... completion of each phase of production shall be established to assure the quality of the drug product...

21 CFR 211.111 - Time limitations on production.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and... completion of each phase of production shall be established to assure the quality of the drug product...

[The network of health promoting companies (WHP) in the province of Bergamo].

PubMed

Moretti, R; Cremaschini, M; Brembilla, G; Franchin, D; Barbaglio, G; Sarnataro, F; Spada, P; Mologni, G; Fiandri, R

2012-01-01

To create, by 2012, a network of Promoting Health companies in the Province of Bergamo, with at least 10% of companies with over 90 employees (about 10,000 workers) adherent, and attending up to 15% by 2015. The work was carried out by building partnerships and collaboration with Confindustria Bergamo and the main healthcare and Union stakeholders in the province, selecting good practices and experimenting feasibility and effectiveness in two mid-sized companies, before extending the proposal A system of accreditation was defined. Member companies should implement a at least 18 good practices in three years. The areas of good practices are: nutrition, tobacco, physical activity, road safety, alcohol and substance and wellbeing. The results are surprising in terms of network and adhesion. Currently 46 companies are involved (over 9,200 employees). The model seems to work well and in our opinion is extensible on a larger scale.

Sports Medicine and Arthroscopic Treatment of the Foot and Ankle: What Is New and Current in Singapore.

PubMed

Ho, Sean Wei Loong; Thevendran, Gowreeson

2016-06-01

Foot and ankle abnormalities are common in Singapore because of the compulsory conscription, the slipper-wearing culture, and the promotion of healthy living through exercise. The rapidly aging population, lack of elite sportsmen, and social and cultural norms pose unique challenges to foot and ankle surgery. Orthopedic surgery in Singapore has progressed because of the good infrastructure and modern practices executed by fellowship-trained surgeons. Evolving local practices are polarized by practice trends emulated from North America and Europe. The small community of foot and ankle surgeons currently practicing in Singapore allows for easier communication, corroborative educational events, and research initiatives. Copyright © 2016 Elsevier Inc. All rights reserved.

21 CFR 26.10 - Regulatory authorities not listed as currently equivalent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2014 CFR

2014-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2011 CFR

2011-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2013 CFR

2013-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

21 CFR 886.1400 - Maddox lens.

Code of Federal Regulations, 2012 CFR

2012-04-01

... intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction. (b) Classification... the current good manufacturing practice requirements of the quality system regulation in part 820 of...

Reconstructing Iraq

DTIC Science & Technology

2004-09-02

ICG Middle East Report N°30, 2 September 2004 Page 16 and institutions to counter monopolistic practices harmful to both investors and consumers ...204 A senior Ministry of Trade official described large-scale corruption in the food and consumer goods rationing system at all 198 ICG...procurement of items for the ration system also provides fertile ground for current corruption. Black markets thrive on goods whose prices are kept

21 CFR 184.1315 - Ferrous sulfate.

Code of Federal Regulations, 2011 CFR

2011-04-01

... iron. It occurs as pale, bluish-green crystals or granules. Progressive heating of ferrous sulfate... § 170.3(o)(24) of this chapter, with no limitation other than current good manufacturing practice. The...

Create a good learning environment and motivate active learning enthusiasm

NASA Astrophysics Data System (ADS)

Bi, Weihong; Fu, Guangwei; Fu, Xinghu; Zhang, Baojun; Liu, Qiang; Jin, Wa

2017-08-01

In view of the current poor learning initiative of undergraduates, the idea of creating a good learning environment and motivating active learning enthusiasm is proposed. In practice, the professional tutor is allocated and professional introduction course is opened for college freshman. It can promote communication between the professional teachers and students as early as possible, and guide students to know and devote the professional knowledge by the preconceived form. Practice results show that these solutions can improve the students interest in learning initiative, so that the active learning and self-learning has become a habit in the classroom.

Modeling Speed-Accuracy Tradeoff in Adaptive System for Practicing Estimation

ERIC Educational Resources Information Center

Nižnan, Juraj

2015-01-01

Estimation is useful in situations where an exact answer is not as important as a quick answer that is good enough. A web-based adaptive system for practicing estimates is currently being developed. We propose a simple model for estimating student's latent skill of estimation. This model combines a continuous measure of correctness and response…

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...

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.

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.

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.

Reliability, Validity, and Factor Structure of the Current Assessment Practice Evaluation-Revised (CAPER) in a National Sample.

PubMed

Lyon, Aaron R; Pullmann, Michael D; Dorsey, Shannon; Martin, Prerna; Grigore, Alexandra A; Becker, Emily M; Jensen-Doss, Amanda

2018-05-11

Measurement-based care (MBC) is an increasingly popular, evidence-based practice, but there are no tools with established psychometrics to evaluate clinician use of MBC practices in mental health service delivery. The current study evaluated the reliability, validity, and factor structure of scores generated from a brief, standardized tool to measure MBC practices, the Current Assessment Practice Evaluation-Revised (CAPER). Survey data from a national sample of 479 mental health clinicians were used to conduct exploratory and confirmatory factor analyses, as well as reliability and validity analyses (e.g., relationships between CAPER subscales and clinician MBC attitudes). Analyses revealed competing two- and three-factor models. Regardless of the model used, scores from CAPER subscales demonstrated good reliability and convergent and divergent validity with MBC attitudes in the expected directions. The CAPER appears to be a psychometrically sound tool for assessing clinician MBC practices. Future directions for development and application of the tool are discussed.

Ecological models supporting environmental decision making: a strategy for the future

USGS Publications Warehouse

Schmolke, Amelie; Thorbek, Pernille; DeAngelis, Donald L.; Grimm, Volker

2010-01-01

Ecological models are important for environmental decision support because they allow the consequences of alternative policies and management scenarios to be explored. However, current modeling practice is unsatisfactory. A literature review shows that the elements of good modeling practice have long been identified but are widely ignored. The reasons for this might include lack of involvement of decision makers, lack of incentives for modelers to follow good practice, and the use of inconsistent terminologies. As a strategy for the future, we propose a standard format for documenting models and their analyses: transparent and comprehensive ecological modeling (TRACE) documentation. This standard format will disclose all parts of the modeling process to scrutiny and make modeling itself more efficient and coherent.

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

Good practices in free-energy calculations.

PubMed

Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christophe

2010-08-19

As access to computational resources continues to increase, free-energy calculations have emerged as a powerful tool that can play a predictive role in a wide range of research areas. Yet, the reliability of these calculations can often be improved significantly if a number of precepts, or good practices, are followed. Although the theory upon which these good practices rely has largely been known for many years, it is often overlooked or simply ignored. In other cases, the theoretical developments are too recent for their potential to be fully grasped and merged into popular platforms for the computation of free-energy differences. In this contribution, the current best practices for carrying out free-energy calculations using free energy perturbation and nonequilibrium work methods are discussed, demonstrating that at little to no additional cost, free-energy estimates could be markedly improved and bounded by meaningful error estimates. Monitoring the probability distributions that underlie the transformation between the states of interest, performing the calculation bidirectionally, stratifying the reaction pathway, and choosing the most appropriate paradigms and algorithms for transforming between states offer significant gains in both accuracy and precision.

21 CFR 74.2053 - D&C Black No. 3.

Code of Federal Regulations, 2010 CFR

2010-04-01

... may be avoided by current good manufacturing practices: (1) Calcium hydroxyapatite (CaO and P2O5), not...) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 mg/kg (5 ppm). (c) Uses and restrictions...

Petition to request an exemption from 100 percent identity testing of dietary ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Interim final rule.

PubMed

2007-06-25

The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.

An Investigation into Customer Service Policies and Practices within the Scottish College Library Sector: A Comparison between the Customer Service Exemplars from the Retail Sector with Current Scottish College Library Practice

ERIC Educational Resources Information Center

Paterson, Neil

2011-01-01

The aim of this research project was to investigate the customer care methods within the Scottish college library sector. The researcher sought to compare examples of the customer care and service policies and practices from the sector with exemplars of good customer service from the retail sector. A qualitative, grounded theory approach was…

Supporting good practice in the provision of services to people with comorbid mental health and alcohol and other drug problems in Australia: describing key elements of good service models.

PubMed

Merkes, Monika; Lewis, Virginia; Canaway, Rachel

2010-12-03

The co-occurrence of mental illness and substance use problems (referred to as "comorbidity" in this paper) is common, and is often reported by service providers as the expectation rather than the exception. Despite this, many different treatment service models are being used in the alcohol and other drugs (AOD) and mental health (MH) sectors to treat this complex client group. While there is abundant literature in the area of comorbidity treatment, no agreed overarching framework to describe the range of service delivery models is apparent internationally or at the national level. The aims of the current research were to identify and describe elements of good practice in current service models of treatment of comorbidity in Australia. The focus of the research was on models of service delivery. The research did not aim to measure the client outcomes achieved by individual treatment services, but sought to identify elements of good practice in services. Australian treatment services were identified to take part in the study through a process of expert consultation. The intent was to look for similarities in the delivery models being implemented across a diverse set of services that were perceived to be providing good quality treatment for people with comorbidity problems. A survey was designed based on a concept map of service delivery devised from a literature review. Seventeen Australian treatment services participated in the survey, which explored the context in which services operate, inputs such as organisational philosophy and service structure, policies and procedures that guide the way in which treatment is delivered by the service, practices that reflect the way treatment is provided to clients, and client impacts. The treatment of people with comorbidity of mental health and substance use disorders presents complex problems that require strong but flexible service models. While the treatment services included in this study reflected the diversity of settings and approaches described in the literature, the research found that they shared a range of common characteristics. These referred to: service linkages; workforce; policies, procedures and practices; and treatment.

Judgments of learning are significantly higher following feedback on relatively good versus relatively poor trials despite no actual learning differences.

PubMed

Carter, Michael J; Smith, Victoria; Ste-Marie, Diane M

2016-02-01

Studies have consistently shown that prospective metacognitive judgments of learning are often inaccurate because humans mistakenly interpret current performance levels as valid indices of learning. These metacognitive discrepancies are strongly related to conditions of practice. Here, we examined how the type of feedback (after good versus poor trials) received during practice and awareness (aware versus unaware) of this manipulation affected judgments of learning and actual learning. After each six-trial block, participants received feedback on their three best trials or three worst trials and half of the participants were made explicitly aware of the type of feedback they received while the other half were unaware. Judgments of learning were made at the end of each six-trial block and before the 24-h retention test. Results indicated no motor performance differences between groups in practice or retention; however, receiving feedback on relatively good compared to relatively poor trials resulted in significantly higher judgments of learning in practice and retention, irrespective of awareness. These results suggest that KR on relatively good versus relatively poor trials can have dissociable effects on judgments of learning in the absence of actual learning differences, even when participants are made aware of their feedback manipulation. Copyright © 2015 Elsevier B.V. All rights reserved.

Developing a policy for paediatric biobanks: principles for good practice

PubMed Central

Hens, Kristien; Van El, Carla E; Borry, Pascal; Cambon-Thomsen, Anne; Cornel, Martina C; Forzano, Francesca; Lucassen, Anneke; Patch, Christine; Tranebjaerg, Lisbeth; Vermeulen, Eric; Salvaterra, Elena; Tibben, Aad; Dierickx, Kris

2013-01-01

The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions. PMID:22713814

Defense AT and L Magazine. Vol. 46, no. 5, September-October 2017

DTIC Science & Technology

2017-09-01

service , and current DoD employees. College Students: Industry is offering internships as early as the sophomore year. DoD branding needs to...engineering neglect of known good practice that can result in persistent public, user, customer , staff, reputation or financial cost. In truth...DoD’s Acquisition Defense AT&L: September-October 2017 20 Workforce professionals and leaders unmistakably need to obtain more goods and services

Good enough practices in scientific computing.

PubMed

Wilson, Greg; Bryan, Jennifer; Cranston, Karen; Kitzes, Justin; Nederbragt, Lex; Teal, Tracy K

2017-06-01

Computers are now essential in all branches of science, but most researchers are never taught the equivalent of basic lab skills for research computing. As a result, data can get lost, analyses can take much longer than necessary, and researchers are limited in how effectively they can work with software and data. Computing workflows need to follow the same practices as lab projects and notebooks, with organized data, documented steps, and the project structured for reproducibility, but researchers new to computing often don't know where to start. This paper presents a set of good computing practices that every researcher can adopt, regardless of their current level of computational skill. These practices, which encompass data management, programming, collaborating with colleagues, organizing projects, tracking work, and writing manuscripts, are drawn from a wide variety of published sources from our daily lives and from our work with volunteer organizations that have delivered workshops to over 11,000 people since 2010.

The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore.

PubMed

Hashan, Hajed; Aljuffali, Ibrahim; Patel, Prisha; Walker, Stuart

This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence. A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore's Health Sciences Authority, and Australia's Therapeutic Goods Administration. All four regulatory agencies have established target times for scientific assessment and regulatory review, examine dossier sections in parallel, and separate company response time from overall timing. Additionally, all four agencies have instituted good review practices including standard operating procedures, templates, dossier monitoring, and continuous improvement processes, and assign a high priority to transparency in their relationships with the public, healthcare professionals and industry. Of the four agencies, however, only the SFDA requires a Certificate of Pharmaceutical Product (CPP) at the time of the submission and pricing negotiations before final product approval. To assist the SFDA in its efforts to become a Regional Centre of Excellence, it is suggested that the agency explore a risk stratification approach to select dossiers for verification, abridged, or full reviews; use forms of certification other than the CPP; make pricing negotiations independent to the review process; and introduce a feedback process for the quality of the dossier.

Development of a precast bridge deck overhang system

DOT National Transportation Integrated Search

2011-02-01

Prestressed-precast panels are commonly used at interior beams for bridge decks in Texas. The use of these panels can provide ease : of construction, sufficient capacity, and good economy for the construction of bridge decks in Texas. Current practic...

75 FR 79763 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... Current Food Good Manufacturing Practices Regulation 0910-AG36 Food and Drug Administration--Completed... Sequence Title Identifier Number Number 310 Quality Assurance Requirements for Respirators 0920-AA04 Food and Drug Administration--Prerule Stage Regulation Sequence Title Identifier Number Number 311 Food...

Measurement Theory in Language Testing: Past Traditions and Current Trends

ERIC Educational Resources Information Center

Salmani-Nodoushan, Mohammad Ali

2009-01-01

A good test is one that has at least three qualities: reliability, or the precision with which a test measures what it is supposed to measure; validity, i.e., if the test really measures what it is supposed to measure, and practicality, or if the test, no matter how sound theoretically, is practicable in reality. These are the sine qua non for any…

Where to find information about drugs

PubMed Central

Day, Richard O; Snowden, Leone

2016-01-01

SUMMARY Good medicines information is critical to medical practice. Choose high-quality, pre-appraised sources first and make sure they are current. Select the information that is most relevant to the needs of your particular patient. Take the time to become familiar with the features of the resources you use. Australian Medicines Handbook, Therapeutic Guidelines, Australian Prescriber and NPS MedicineWise cover most routine clinical practice needs. PMID:27346917

Measurement Theory in Language Testing: Past Traditions and Current Trends

ERIC Educational Resources Information Center

Salmani-Nodoushan, Mohammad Ali

2009-01-01

A good test is one that has at least three qualities: reliability, or the precision with which a test measures what it is supposed to measure; validity, i.e., if the test really measures what it is supposed to measure; and practicality, or if the test, no matter how sound theoretically, is practicable in reality. These are the sine qua non for…

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.

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...

21 CFR 211.48 - Plumbing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...

21 CFR 211.48 - Plumbing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...

21 CFR 211.48 - Plumbing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...

21 CFR 211.48 - Plumbing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...

Good practices and health policy analysis in European sports stadia: results from the 'Healthy Stadia' project.

PubMed

Drygas, Wojciech; Ruszkowska, Joanna; Philpott, Matthew; Björkström, Olav; Parker, Mike; Ireland, Robin; Roncarolo, Federico; Tenconi, Maria

2013-06-01

Sport plays an important role within society and sports stadia provide significant settings for public health strategies. In addition to being places of mass gathering, stadia are often located in less affluent areas and are traditionally attended by 'harder to reach' communities. Unfortunately sports stadia and the clubs they host are rarely perceived as places that promote healthy lifestyles. Fast food, alcohol and tobacco are commonly advertized, served and consumed during sports games giving the spectators and TV fans contradictory messages concerning healthy choices. As part of a wider programme of work part-funded by the European Union, a study was therefore designed to explore current 'good practice' relating to positive health interventions in sports stadia across a number of European countries. Using a specially designed questionnaire, information about health policies and good practices relating to food offerings in stadia, physical activity promotion among local communities, tobacco policy, positive mental health initiatives, environmental sustainability practices and social responsibility policies were collected in 10 European countries (England and Northern Ireland, Finland, Georgia, Greece, Ireland, Italy, Latvia, Poland, Spain and Sweden) involving 88 stadia. The audit results show that stadia health policies differ considerably between specific countries and sports. Based on the literature analysed, the examples of good practices collected through the study, and the subsequent instigation of a European Healthy Stadia Network, it shows that there is considerable potential for stadia to become health promoting settings.

Exploring the scope of expanding advanced nursing practice in nurse-led clinics: a multiple-case study.

PubMed

Shiu, Ann T Y; Lee, Diana T F; Chau, Janita P C

2012-08-01

This article is a report on a study to explore the development of expanding advanced nursing practice in nurse-led clinics in Hong Kong. Nurse-led clinics serviced by advanced practice nurses, a common international practice, have been adopted in Hong Kong since 1990s. Evaluations consistently show that this practice has good clinical outcomes and contributes to containing healthcare cost. However, similar to the international literature, it remains unclear as to what the elements of good advanced nursing practice are, and which directions Hong Kong should adopt for further development of such practice. A multiple-case study design was adopted with six nurse-led clinics representing three specialties as six case studies, and including two clinics each from continence, diabetes and wound care. Each case had four embedded units of analysis. They included non-participant observation of nursing activities (9 days), nurse interviews (N = 6), doctor interviews (N = 6) and client interviews (N = 12). The data were collected in 2009. Within- and cross-case analyses were conducted. The cross-case analysis demonstrated six elements of good advanced nursing practice in nurse-led clinics, and showed a great potential to expand the practice by reshaping four categories of current boundaries, including community-hospital, wellness-illness, public-private and professional-practice boundaries. From these findings, we suggest a model to advance the scope of advanced nursing practice in nurse-led clinics. The six elements may be applied as audit criteria for evaluation of advanced nursing practice in nurse-led clinics, and the proposed model provides directions for expanding such practice in Hong Kong and beyond. © 2011 Blackwell Publishing Ltd.

Pressure area care: an exploration of Greek nurses' knowledge and practice.

PubMed

Panagiotopoulou, Kalliopi; Kerr, Susan M

2002-11-01

Despite a plethora of information on the prevention of pressure sores, they remain a significant problem in both hospital and community settings. The need to reduce the incidence of pressure sores has been well documented; unfortunately there is little evidence to suggest improvement. The reasons for this lack of improvement have been explored, but the picture remains unclear. While some studies have suggested that nurses have the appropriate knowledge to prevent pressure sores developing (but do not use their knowledge), others suggest that nurses' knowledge of preventive strategies is deficient. In Greece, similarly to the United Kingdom (UK), the incidence of pressure sores is high. There is currently no evidence on Greek nurses' knowledge and practice and therefore no baseline on which to build, in terms of improving practice. The purpose of this study was to explore Greek nurses' knowledge of 'risk factors', 'areas at risk' and 'recommended preventive strategies' in relation to pressure area care. In addition, information was sought on nurses' 'current preventive practice' and any barriers to 'good practice'. The study was exploratory and descriptive, adopting a cross-sectional survey approach. The sample was drawn from the population of nurses working in a military hospital near Athens. The data were collected over a 4-week period in June 2000, using a self-completed questionnaire. Although the knowledge-base of many of the nurses was good in relation to 'risk factors' and 'areas at risk', a significant proportion were unaware that methods such as 'massage' and 'donuts' are no longer recommended. This lack of knowledge influenced practice with these methods commonly being used. In relation to barriers to good practice, a significant proportion of nurses reported that they could not access, read or understand research findings. This has obvious implications for the implementation of evidence-based practice. The results of this study suggest that the knowledge and practice of participants could be improved. It is of particular concern that methods known to be detrimental were in common use. Finally, there is a need to improve the research skills of Greek nurses in order to provide them with the appropriate knowledge to use research findings.

Who does workforce planning well? Workforce review team rapid review summary.

PubMed

Curson, J A; Dell, M E; Wilson, R A; Bosworth, D L; Baldauf, B

2010-01-01

This paper sets out to disseminate new knowledge about workforce planning, a crucial health sector issue. The Health Select Committee criticised NHS England's failure to develop and apply effective workforce planning. The Workforce Review Team (WRT) commissioned the Institute for Employment Research, Warwick University, to undertake a "rapid review" of global literature to identify good practice. A workforce planning overview, its theoretical principles, good practice exemplars are provided before discussing their application to healthcare. The literature review, undertaken September-November 2007, determined the current workforce planning evidence within and outside health service provision and any consensus on successful workforce planning. Much of the literature was descriptive and there was a lack of comparative or evaluative research-based evidence to inform U.K. healthcare workforce planning. Workforce planning practices were similar in other countries. There was no evidence to challenge current WRT approaches to NHS England workforce planning. There are a number of indications about how this might be extended and improved, given additional resources. The evidence-base for workforce planning would be strengthened by robust and authoritative studies. Systematic workforce planning is a key healthcare quality management element. This review highlights useful information that can be turned into knowledge by informed application to the NHS. Best practice in other sectors and other countries appears to warrant exploration.

[Good professional practices of French CICs - version # 2].

PubMed

Chevassus, Hugues; Duchesne, Charlène; Sailly, Annabelle; Vigouroux, Céline; Foulon, Christine; Kubiak, Christine; Binquet, Christine; Felin, Alexandra Lamotte; Chaud, Pascal; Thalamas, Claire; Cornu, Catherine

2017-10-01

French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Public nutrition in complex emergencies.

PubMed

Young, Helen; Borrel, Annalies; Holland, Diane; Salama, Peter

Public nutrition is a broad-based, problem-solving approach to addressing malnutrition in complex emergencies that combines analysis of nutritional risk and vulnerability with action-oriented strategies, including policies, programmes, and capacity development. This paper focuses on six broad areas: nutritional assessment, distribution of a general food ration, prevention and treatment of moderate malnutrition, treatment of severe malnutrition in children and adults, prevention and treatment of micronutrient deficiency diseases, and nutritional support for at-risk groups, including infants, pregnant and lactating women, elderly people, and people living with HIV. Learning and documenting good practice from previous emergencies, the promotion of good practice in current emergencies, and adherence to international standards and guidelines have contributed to establishing the field of public nutrition. However, many practical challenges reduce the effectiveness of nutritional interventions in complex emergencies, and important research and programmatic questions remain.

21 CFR 225.20 - Buildings.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Construction and Maintenance of Facilities and Equipment § 225.20 Buildings. (a) The location, design, construction, and physical size of the buildings and other production facilities are factors important to the manufacture of medicated feed. The features of...

21 CFR 226.30 - Equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Construction and Maintenance of Facilities and Equipment § 226.30 Equipment. Equipment used for the manufacture, processing, packaging, bulk... maintained in a clean and orderly manner and shall be of suitable design, size, construction, and location to...

21 CFR 225.30 - Equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Construction and Maintenance of Facilities and Equipment § 225.30 Equipment. (a) Equipment which is designed to perform its intended function and is properly installed and used is essential to the manufacture of medicated feeds. Such equipment permits...

21 CFR 111.365 - What precautions must you take to prevent contamination?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN... necessary, the phase of manufacturing; and (k) Identifying all processing lines and major equipment used... specific batch or lot number and, when necessary, the phase of manufacturing. ...

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...

Development of a precast bridge deck overhang system for the rock creek bridge.

DOT National Transportation Integrated Search

2008-12-01

Precast, prestressed panels are commonly used at interior beams for bridges in Texas. The use of these : panels provides ease of construction, sufficient capacity, and good economy for the construction of : bridges in Texas. Current practice for the ...

21 CFR 110.10 - Personnel.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General... contamination of food. The methods for maintaining cleanliness include, but are not limited to: (1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food...

21 CFR 868.6225 - Nose clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ANESTHESIOLOGY DEVICES Miscellaneous § 868.6225 Nose clip. (a) Identification. A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

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 211.142 - Warehousing procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

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 211.142 - Warehousing procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

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 211.25 - Personnel qualifications.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Personnel qualifications. 211.25 Section 211.25 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 Personnel § 211...

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 211.142 - Warehousing procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

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 211.65 - Equipment construction.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment construction. 211.65 Section 211.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.65 Equipment...

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 211.56 - Sanitation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

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 211.56 - Sanitation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

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 211.44 - Lighting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

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 211.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

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 211.130 - 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...

21 CFR 211.68 - Automatic, mechanical, and electronic equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS... satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such... designed to assure proper performance. Written records of those calibration checks and inspections shall be...

21 CFR 225.202 - Formula, production, and distribution records.

Code of Federal Regulations, 2014 CFR

2014-04-01

... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Formula, production, and distribution records. 225...

21 CFR 225.202 - Formula, production, and distribution records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Formula, production, and distribution records. 225...

21 CFR 225.202 - Formula, production, and distribution records.

Code of Federal Regulations, 2013 CFR

2013-04-01

... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Formula, production, and distribution records. 225...

21 CFR 225.202 - Formula, production, and distribution records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Formula, production, and distribution records. 225...

21 CFR 110.19 - Exclusions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Exclusions. 110.19 Section 110.19 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General...

21 CFR 110.19 - Exclusions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Exclusions. 110.19 Section 110.19 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General...

21 CFR 111.210 - What must the master manufacturing record include?

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING... manufactured and the strength, concentration, weight, or measure of each dietary ingredient for each batch size... actual or representative label; (h) Written instructions, including the following: (1) Specifications for...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

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...

21 CFR 606.20 - Personnel.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Personnel. 606.20 Section 606.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Organization and Personnel § 606.20...

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...

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 211.48 - Plumbing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Plumbing. 211.48 Section 211.48 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48...

21 CFR 226.20 - Buildings.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Buildings. 226.20 Section 226.20 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 Construction and Maintenance of...

21 CFR 509.7 - Unavoidability.

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements in this chapter that food manufacturers must observe current good manufacturing practices... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Unavoidability. 509.7 Section 509.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS...

21 CFR 110.35 - Sanitary operations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... against contamination of food. (1) Food-contact surfaces used for manufacturing or holding low-moisture... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD... for contamination. Only the following toxic materials may be used or stored in a plant where food is...

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...

21 CFR 211.28 - Personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Personnel responsibilities. 211.28 Section 211.28 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 Personnel § 211...

21 CFR 110.93 - Warehousing and distribution.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING... microbial contamination as well as against deterioration of the food and the container. ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Warehousing and distribution. 110.93 Section 110...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 109.7 - Unavoidability.

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements in this chapter that food manufacturers must observe current good manufacturing practices... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Unavoidability. 109.7 Section 109.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. Final rule.

PubMed

2016-11-18

The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.

The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.

PubMed

Arjmand, Babak; Emami-Razavi, Seyed Hassan; Larijani, Bagher; Norouzi-Javidan, Abbas; Aghayan, Hamid Reza

2012-12-01

Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greater risk of complications and possibly adverse events for the recipient, and so the need for control is correspondingly greater. To minimize the associate risks of cell manufacturing adhering to international quality standards is critical. Current good tissue practice (cGTP) and current good manufacturing practice (cGMP) are examples of general standards that draw a baseline for cell manufacturing facilities. In recent years, stem cell researches have found great public interest in Iran and different cell therapy projects have been started in country. In this review we described the role of our tissue banking experiences in establishing a new cGMP cell manufacturing facility. The authors concluded that, tissue banks and tissue banking experts can broaden their roles from preparing tissue grafts to manufacturing cell and tissue engineered products for translational researches and phase I clinical trials. Also they can collaborate with cell processing laboratories to develop SOPs, implement quality management system, and design cGMP facilities.

Report of a Meeting on Contemporary Topics in Zebrafish Husbandry and Care

PubMed Central

Osborne, Nikki; Paull, Gregory; Grierson, Adam; Dunford, Karen; Busch-Nentwich, Elisabeth M.; Sneddon, Lynne U.; Wren, Natalie; Higgins, Joe

2016-01-01

Abstract A meeting on Contemporary Topics in Zebrafish Husbandry and Care was held in the United Kingdom in 2014, with the aim of providing a discussion forum for researchers, animal technologists, and veterinarians from academia and industry to share good practice and exchange ideas. Presentation topics included protocols for optimal larval rearing, implementing the 3Rs (replacement, reduction, and refinement) in large-scale colony management, and environmental enrichment. The audience also participated in a survey of current practice relating to practical husbandry, cryopreservation, and the provision of enrichment. PMID:27537782

Report of a Meeting on Contemporary Topics in Zebrafish Husbandry and Care.

PubMed

Osborne, Nikki; Paull, Gregory; Grierson, Adam; Dunford, Karen; Busch-Nentwich, Elisabeth M; Sneddon, Lynne U; Wren, Natalie; Higgins, Joe; Hawkins, Penny

2016-12-01

A meeting on Contemporary Topics in Zebrafish Husbandry and Care was held in the United Kingdom in 2014, with the aim of providing a discussion forum for researchers, animal technologists, and veterinarians from academia and industry to share good practice and exchange ideas. Presentation topics included protocols for optimal larval rearing, implementing the 3Rs (replacement, reduction, and refinement) in large-scale colony management, and environmental enrichment. The audience also participated in a survey of current practice relating to practical husbandry, cryopreservation, and the provision of enrichment.

Good manufacturing practices for medicinal products for human use.

PubMed

Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.

Good manufacturing practices for medicinal products for human use

PubMed Central

Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

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 211.194 - Laboratory records.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

21 CFR 211.111 - Time limitations on production.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Time limitations on production. 211.111 Section 211.111 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...

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 211.198 - Complaint files.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.198 - Complaint files.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

21 CFR 211.180 - 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. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

21 CFR 211.198 - Complaint files.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

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 211.111 - Time limitations on production.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Time limitations on production. 211.111 Section 211.111 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...

21 CFR 211.180 - 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. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

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 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

21 CFR 211.180 - 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. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

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 211.180 - 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. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

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 211.198 - Complaint files.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

21 CFR 211.111 - Time limitations on production.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Time limitations on production. 211.111 Section 211.111 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...

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 211.198 - Complaint files.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

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 606.40 - Facilities.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Facilities. 606.40 Section 606.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Plant and Facilities § 606.40 Facilities...

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. ...

How to Submit | Center for Cancer Research

Cancer.gov

be submitted by a current NIH or FDA fellow. The work does not need to have been done at the NIH/FDA. However, the submitter must be an author on the document and be in compliance with the intended journal's authorship guidelines or general good authorship practices. 

21 CFR 211.196 - Distribution records.

Code of Federal Regulations, 2011 CFR

2011-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Distribution records. 211.196 Section 211.196 Food...

21 CFR 211.196 - Distribution records.

Code of Federal Regulations, 2013 CFR

2013-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Distribution records. 211.196 Section 211.196 Food...

21 CFR 211.196 - Distribution records.

Code of Federal Regulations, 2014 CFR

2014-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Distribution records. 211.196 Section 211.196 Food...

21 CFR 211.196 - Distribution records.

Code of Federal Regulations, 2012 CFR

2012-04-01

...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Distribution records. 211.196 Section 211.196 Food...

21 CFR 1271.290 - Tracking.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.290 Tracking. (a) General. If you perform any... designed to facilitate effective tracking, using the distinct identification code, from the donor to the... for recording the distinct identification code and type of each HCT/P distributed to a consignee to...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 111.12 - What personnel qualification requirements apply?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What personnel qualification requirements apply? 111.12 Section 111.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

21 CFR 111.12 - What personnel qualification requirements apply?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What personnel qualification requirements apply? 111.12 Section 111.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

21 CFR 111.12 - What personnel qualification requirements apply?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What personnel qualification requirements apply? 111.12 Section 111.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2011 CFR

2011-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2012 CFR

2012-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2014 CFR

2014-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 184.1639 - Potassium lactate.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... No. 996-31-6) is the potassium salt of lactic acid. It is a hydroscopic, white, odorless solid and is prepared commercially by the neutralization of lactic acid with potassium hydroxide. (b) The ingredient... current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses...

21 CFR 184.1639 - Potassium lactate.

Code of Federal Regulations, 2012 CFR

2012-04-01

.... No. 996-31-6) is the potassium salt of lactic acid. It is a hydroscopic, white, odorless solid and is prepared commercially by the neutralization of lactic acid with potassium hydroxide. (b) The ingredient... current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses...

21 CFR 184.1639 - Potassium lactate.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... No. 996-31-6) is the potassium salt of lactic acid. It is a hydroscopic, white, odorless solid and is prepared commercially by the neutralization of lactic acid with potassium hydroxide. (b) The ingredient... current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses...

21 CFR 184.1639 - Potassium lactate.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... No. 996-31-6) is the potassium salt of lactic acid. It is a hydroscopic, white, odorless solid and is prepared commercially by the neutralization of lactic acid with potassium hydroxide. (b) The ingredient... current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses...

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...

21 CFR 606.40 - Facilities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Facilities. 606.40 Section 606.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Plant and Facilities § 606.40 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...

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...

21 CFR 211.42 - Design and construction features.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Design and construction features. 211.42 Section 211.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities...

21 CFR 225.165 - Equipment cleanout procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Equipment cleanout procedures. 225.165 Section 225.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Assurance § 225...

Student Complainants--Vexatious or Vulnerable?

ERIC Educational Resources Information Center

Millward, Christine V.

2016-01-01

In December 2014, the Office of the Independent Adjudicator (OIA) introduced the "Good practice framework for handling complaints and academic appeals" which will inform external judgement on each university's approach to conflict management from the current academic year 2015-2016. The framework aims to improve the complaint process for…

Why evidence-based medicine is a good approach in physical and rehabilitation medicine. Thesis.

PubMed

Negrini, S

2014-10-01

According to a good definition, evidence-based medicine (EBM) is: "The explicit, conscientious, and judicious use of the current best evidence in making decisions about the care of individual patients (and populations)". More appropriate in a clinical context like that of physical and rehabilitation medicine (PRM) is looking at evidence based clinical practice (EBCP), whose definition is: "The integration of best research evidence with clinical expertise and patient values". In the past the term evidence-based physical and rehabilitation medicine (EBPRM) was also proposed. In this thesis, after some historical notes on EBM and on PRM, we will discuss why in our view EBPRM must be the real foundation of our everyday PRM clinical practice.

[Best practice guide for radiation therapy of non-small cell bronchial cancers].

PubMed

Martel-Lafay, I; Fourneret, P; Ayadi, M; Brun, O; Buatois, F; Carrie, C; Chilles, A; Claude, L; Cottin-Durrleman, G; Farsi, F; Fournel, P; Mongodin, B; Pouchard, I; Balestrière, V; Suchaud, J P

2009-01-01

The objective was the drafting of a practical document intended for radiotherapists and radiophysicists, describing the technique of irradiation of a non small cell bronchial cancer. The good practices concern the care of patients affected by bronchial cancer localized in the thorax and inoperable or patients who must undergo postoperative irradiation. The document has been developed according to a methodology aiming to join the current scientific data from an analysis of the literature on the subject and the assessment of radiotherapists, radiophysicists, lung specialists and methodologists from Rhône-Alpes area. From the stages necessary for the good progress of a radiotherapy, the writers of this document proposed common definitions concerning the centering and the location of the zone to be treated, the calculation of the dose distribution, the preparation of the patient for the treatment, the treatment and the surveillance during the treatment. The recommendations of this guide took into account the peculiarities bound to the nature of the treated region and more particularly the lung heterogeneity, respiratory movements and the radiosensibility of healthy lung tissue. Even if the technical aspect of the radiotherapy was particularly developed, the interest accorded to patient information takes on all its importance for a therapeutic coverage of quality. The authors of the document wished that this Guide of Good Practices, which will be regularly updated, helps the radiotherapists and allows them to harmonize their practices.

Emergency management training program: Guide to good practice

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

Not Available

1991-07-01

The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager's point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less

Emergency management training program: Guide to good practice

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

Not Available

1991-07-01

The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager`s point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less

21 CFR 74.1327 - D&C Red No. 27.

Code of Federal Regulations, 2010 CFR

2010-04-01

... bromine. The 4,5,6,7-tetrachlorofluorescein is manufactured by the acid condensation of resorcinol and tetrachlorophthalic acid or its anhydride. The 4,5,6,7-tetrachlorofluorescein is isolated and partially purified prior... avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and halides and...

21 CFR 606.165 - Distribution and receipt; procedures and records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records..., or for crossmatched blood and blood components, the name of the recipient. (c) Receipt records shall contain the name and address of the collecting facility, date received, donor or lot number assigned by...

21 CFR 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Equipment cleaning and use log. 211.182 Section 211.182 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and...

21 CFR 211.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. (a) The regulations in...

21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

21 CFR 211.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. (a) The regulations in...

21 CFR 211.50 - Sewage and refuse.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Sewage and refuse. 211.50 Section 211.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.50 Sewage...

21 CFR 211.89 - Rejected 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 Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

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 211.22 - 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 211.192 - Production record review.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 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...

21 CFR 211.89 - Rejected 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 Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

21 CFR 211.89 - Rejected 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 Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

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 211.22 - 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 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment cleaning and use log. 211.182 Section 211.182 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 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...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

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 211.89 - Rejected 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 Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

21 CFR 211.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. (a) The regulations in...

21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

21 CFR 211.50 - Sewage and refuse.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Sewage and refuse. 211.50 Section 211.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.50 Sewage...

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 211.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. (a) The regulations in...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 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...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

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...

21 CFR 211.89 - Rejected 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 Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

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 211.50 - Sewage and refuse.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Sewage and refuse. 211.50 Section 211.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.50 Sewage...

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 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment cleaning and use log. 211.182 Section 211.182 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and...

21 CFR 211.50 - Sewage and refuse.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Sewage and refuse. 211.50 Section 211.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.50 Sewage...

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 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

21 CFR 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment cleaning and use log. 211.182 Section 211.182 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and...

21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

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...

21 CFR 111.27 - What requirements apply to the equipment and utensils that you use?

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 Equipment and Utensils § 111... utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for...

E-Learning of Andalusian University's Lecturers. Gender

ERIC Educational Resources Information Center

Tena, Rosalía Romero; Almenara, Julio Cabero; Osuna, Julio Barroso

2016-01-01

This study forms part of the research project: "Use of eLearning in Andalusian Universities: current status and analysis of good practice". Our research focuses on two fundamental areas: firstly, the Virtual Andalusian Campus (VAC) as defined in the Digital University project set up by the Andalusia's Regional Administration, and…

21 CFR 74.2328 - D&C Red No. 28.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2328 D&C Red No. 28. (a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2330 - D&C Red No. 30.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2330 D&C Red No. 30. (a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2706 - FD&C Yellow No. 6.

Code of Federal Regulations, 2010 CFR

2010-04-01

... COLOR ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2706 FD&C Yellow No. 6. (a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the... coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2327 - D&C Red No. 27.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2327 D&C Red No. 27. (a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

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...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2011-04-01 2011-04-01 false Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2010 CFR

2010-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2010 CFR

2010-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 111.5 - Do other statutory provisions and regulations apply?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Do other statutory provisions and regulations apply? 111.5 Section 111.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

75 FR 59266 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations... submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork...

75 FR 60463 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for... Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax...

21 CFR 184.1930 - Vitamin A.

Code of Federal Regulations, 2011 CFR

2011-04-01

.../code_of_federal_regulations/ibr_locations.html. (c) In accordance with § 184.1(b)(1), the ingredient is... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as a... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 226.115 - Complaint files.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Complaint files. 226.115 Section 226.115 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 Records and Reports § 226.115 Complaint...

21 CFR 225.115 - Complaint files.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Complaint files. 225.115 Section 225.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225.115 Complaint files. (a...

Nova Scotia Teachers' ADHD Knowledge, Beliefs, and Classroom Management Practices

ERIC Educational Resources Information Center

Blotnicky-Gallant, Pamela; Martin, Cheron; McGonnell, Melissa; Corkum, Penny

2015-01-01

Attention-deficit/hyperactivity disorder (ADHD) has a significant impact on children's social, emotional, and academic performance in school, and as such, teachers are in a good position to provide evidence-based interventions to help ensure optimal adjustment of their students. The current study examined teachers' knowledge and beliefs about…

75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0605..., or Holding Operations for Dietary Supplements; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

21 CFR 184.1622 - Potassium chloride.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Potassium chloride. 184.1622 Section 184.1622 Food... Specific Substances Affirmed as GRAS § 184.1622 Potassium chloride. (a) Potassium chloride (KCl, CAS Reg... levels not to exceed current good manufacturing practice. Potassium chloride may be used in infant...

21 CFR 184.1622 - Potassium chloride.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Potassium chloride. 184.1622 Section 184.1622 Food... Specific Substances Affirmed as GRAS § 184.1622 Potassium chloride. (a) Potassium chloride (KCl, CAS Reg... levels not to exceed current good manufacturing practice. Potassium chloride may be used in infant...

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...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2012 CFR

2012-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2013 CFR

2013-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1374 - Iron oxides.

Code of Federal Regulations, 2013 CFR

2013-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2013-04-01 2013-04-01 false Iron oxides. 186.1374 Section 186.1374 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

21 CFR 186.1300 - Ferric oxide.

Code of Federal Regulations, 2012 CFR

2012-04-01

... food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice... 21 Food and Drugs 3 2012-04-01 2012-04-01 false Ferric oxide. 186.1300 Section 186.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

Depth of Information Processing and Memory for Medical Facts.

ERIC Educational Resources Information Center

Slade, Peter D.; Onion, Carl W. R.

1995-01-01

The current emphasis in medical education is on engaging learners in deep processing of information to achieve better understanding of the subject matter. Traditional approaches aimed for memorization of medical facts; however, a good memory for medical facts is still essential in clinical practice. This study demonstrates that deep information…

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

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...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

21 CFR 886.1350 - Keratoscope.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...

21 CFR 111.70 - What specifications must you establish?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What specifications must you establish? 111.70 Section 111.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to distributing dietary supplements? 111.470 Section 111.470 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

76 FR 40052 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Current Good Manufacturing 0910-AG10 Practice in Manufacturing, Processing, Packing or Holding Animal Food... in Manufacturing, Processing, Packing or Holding Animal Food Legal Authority: 21 U.S.C. 342; 21 U.S.C... constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or...

21 CFR 211.46 - Ventilation, air filtration, air heating and cooling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Ventilation, air filtration, air heating and cooling. 211.46 Section 211.46 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

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...

76 FR 60052 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

... Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0362...

21 CFR 606.65 - Supplies and reagents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Supplies and reagents. 606.65 Section 606.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Equipment § 606.65 Supplies and...

78 FR 41934 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0731... Determination for Donors; and Current Good Tissue Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...

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...

21 CFR 111.83 - What are the requirements for reserve samples?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the requirements for reserve samples? 111.83 Section 111.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

21 CFR 110.20 - Plant and grounds.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD Buildings and... operator shall be kept in a condition that will protect against the contamination of food. The methods for..., yards, and parking lots so that they do not constitute a source of contamination in areas where food is...

75 FR 11545 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0101... Determination for Donors; and Current Good Tissue Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 74.2706 - FD&C Yellow No. 6.

Code of Federal Regulations, 2012 CFR

2012-04-01

... COLOR ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2706 FD&C Yellow No. 6. (a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the... coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2328 - D&C Red No. 28.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2328 D&C Red No. 28. (a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2328 - D&C Red No. 28.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2328 D&C Red No. 28. (a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2330 - D&C Red No. 30.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2330 D&C Red No. 30. (a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2330 - D&C Red No. 30.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2330 D&C Red No. 30. (a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2327 - D&C Red No. 27.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2327 D&C Red No. 27. (a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2330 - D&C Red No. 30.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2330 D&C Red No. 30. (a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2327 - D&C Red No. 27.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2327 D&C Red No. 27. (a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2327 - D&C Red No. 27.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2327 D&C Red No. 27. (a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2706 - FD&C Yellow No. 6.

Code of Federal Regulations, 2013 CFR

2013-04-01

... COLOR ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2706 FD&C Yellow No. 6. (a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the... coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2706 - FD&C Yellow No. 6.

Code of Federal Regulations, 2014 CFR

2014-04-01

... COLOR ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2706 FD&C Yellow No. 6. (a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the... coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 74.2328 - D&C Red No. 28.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIVES SUBJECT TO CERTIFICATION Cosmetics § 74.2328 D&C Red No. 28. (a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74... cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

21 CFR 1271.230 - Process validation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

Applying TOGAF for e-government implementation based on service oriented architecture methodology towards good government governance

NASA Astrophysics Data System (ADS)

Hodijah, A.; Sundari, S.; Nugraha, A. C.

2018-05-01

As a Local Government Agencies who perform public services, General Government Office already has utilized Reporting Information System of Local Government Implementation (E-LPPD). However, E-LPPD has upgrade limitation for the integration processes that cannot accommodate General Government Offices’ needs in order to achieve Good Government Governance (GGG), while success stories of the ultimate goal of e-government implementation requires good governance practices. Currently, citizen demand public services as private sector do, which needs service innovation by utilizing the legacy system as a service based e-government implementation, while Service Oriented Architecture (SOA) to redefine a business processes as a set of IT enabled services and Enterprise Architecture from the Open Group Architecture Framework (TOGAF) as a comprehensive approach in redefining business processes as service innovation towards GGG. This paper takes a case study on Performance Evaluation of Local Government Implementation (EKPPD) system on General Government Office. The results show that TOGAF will guide the development of integrated business processes of EKPPD system that fits good governance practices to attain GGG with SOA methodology as technical approach.

A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

PubMed

Morales Pedraza, Jorge; Lobo Gajiwala, Astrid; Martinez Pardo, María Esther

2012-03-01

The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

Evidence, Engagement, and Technology: Themes of and the State of Primary Care Practice-based Network Research.

PubMed

Nease, Donald E

2016-01-01

Practice-based research supported by practice-based research network (PBRN) infrastructure has historically provided an important method for challenging guidelines and evidence arising from secondary and tertiary care settings. This sample of current practice-based research in this issue of the JABFM provides an opportunity to ask whether practice-based research continues to address questions relevant to primary care practices and clinicians and whether a PBRN infrastructure is instrumental to maintaining the relevance and feasibility of practice-based research. Based on this issue's articles, the current state of practice-based research seems to be good, at face value addressing relevant issues for primary care practices. Less clear is the degree to which PBRN infrastructures and relationships informed the questions asked and facilitated the implementation of the studies presented. Practice-based research-related articles that routinely report about how study questions arose-from practices and their clinicians, staff and communities, or elsewhere-could help directly answer questions of relevance. In addition, reporting how practices are recruited to practice-based research studies could inform the degree to which ongoing relationships central to PBRNs facilitate the recruitment and conduct of practice-based research. © Copyright 2016 by the American Board of Family Medicine.

75 FR 48179 - Comprehensive List of Guidance Documents at the Food and Drug Administration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

...The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past 5 years.

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.

Prospects for the use of animal cell cultures in screening of pharmaceutical substances

NASA Astrophysics Data System (ADS)

Kolesnikova, S. G.; Moiseeva, I. Y.

2017-01-01

Currently, there is a tendency to reduce the use of animals in conducting safety tests of chemical substances. Therefore, in vitro methods are a good alternative or adjunct to in vivo safety tests. This is especially important at the stage of pre-clinical drug trial. In 2004, the international standard for the principles of good laboratory practice (GLP) [1] was adopted which regulates chemicals trials in cell cultures. However, in Russia, until recently, this issue has been neglected. Research works have been scarce. In 2013, the standard for GLP principles and compliance monitoring was adopted in Russia [2]. The feasibility of using animal cell cultures as drug testing system has been proved by the experimental base and is now being introduced into practice [3].

Issues in practice based learning in nursing in the United Kingdom and the Republic of Ireland: Results from a multi professional scoping exercise.

PubMed

Mallik, Maggie; McGowan, Brian

2007-01-01

The first year (2003-2004) of a three year nationally funded project focused on completing a scoping exercise on the nature of practice education in five selected health care professions: Dietetics, Nursing, Occupational Therapy, Physiotherapy and Radiography (). A survey questionnaire, focus groups and secondary sources were used to collect data. Profession specific contributors completed the analysis of results. Resulting case studies were combined to produce a cross-professional overview of current issues in practice-based learning. The nursing case study identified areas of good practice such as; the mentorship model; the development of new support roles; and joint responsibility between Higher Education Institutes (HEIs) and Health Service areas for practice assessment. However, there were variations in the application of these areas of good practice throughout the United Kingdom (UK). Issues included; an inadequate supply of qualified mentors; formal recognition of the mentor role; and lack of knowledge of the relative impact of the differing mentor preparation programmes. In comparing the five professions, all had statutory requirements regarding the nature of practice learning but each profession differed in how this was managed and organised. The need for formal preparation, recognition and reward for the mentor/practice educator role was recognised with collaborative working across the professions a recommendation in order to achieve national improvement in the quality of practice learning support for health care professions.

Good practice in social care: the views of people with severe and complex needs and those who support them.

PubMed

Gridley, Kate; Brooks, Jenni; Glendinning, Caroline

2014-11-01

This paper reports findings drawn from a study of good practice in English social care for adults with disability and older people with severe and complex needs. People with severe and complex needs are a relatively small proportion of adult social care service users, but they are growing in numbers and have resource-intensive needs. The study involved qualitative research with adults with disability and older people with severe and complex needs, family carers and members of specialist organisations (n = 67), focusing on the features of social care services they considered to be good practice. Data were collected between August 2010 and June 2011. The approach to data collection was flexible, to accommodate participants' communication needs and preferences, including face-to-face and telephone interviews, Talking Mats(©) sessions and a focus group. Data were managed using Framework and analysed thematically. Features of good practice were considered at three levels: (i) everyday support; (ii) service organisation; and (iii) commissioning. Findings relating to the first two of these are presented here. Participants emphasised the importance of person-centred ways of working at all levels. Personalisation, as currently implemented in English social care, aims to shift power from professionals to service users through the allocation of personal budgets. This approach focuses very much on the role of the individual in directing his/her own support arrangements. However, participants in this study also stressed the importance of ongoing professional support, for example, from a specialist key worker or case manager to co-ordinate diverse services and ensure good practice at an organisational level. The paper argues that, despite the recent move to shift power from professionals to service users, people with the most complex needs still value support from professionals and appropriate organisational support. Without these, they risk being excluded from the benefits that personalisation, properly supported, could yield. © 2014 John Wiley & Sons Ltd.

What Good Is Soft Evidence?

ERIC Educational Resources Information Center

Murdach, Allison D.

2010-01-01

Along with other helping professions, social work is today struggling to become a more "evidence-based" activity. This article explores some of the issues raised by this reevaluation of social work, especially as it relates to the issue of direct social work practice. Despite the current push to base social work helping methods on scientific…

21 CFR 74.1340 - FD&C Red No. 40.

Code of Federal Regulations, 2010 CFR

2010-04-01

... amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive... ADDITIVES SUBJECT TO CERTIFICATION Drugs § 74.1340 FD&C Red No. 40. (a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of § 74...

21 CFR 212.20 - What activities must I perform to ensure drug quality?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What activities must I perform to ensure drug quality? 212.20 Section 212.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY...

21 CFR 212.10 - What personnel and resources must I have?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What personnel and resources must I have? 212.10 Section 212.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff...

21 CFR 212.30 - What requirements must my facilities and equipment meet?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What requirements must my facilities and equipment meet? 212.30 Section 212.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY...

21 CFR 212.10 - What personnel and resources must I have?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What personnel and resources must I have? 212.10 Section 212.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS...

21 CFR 212.20 - What activities must I perform to ensure drug quality?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What activities must I perform to ensure drug quality? 212.20 Section 212.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY...

Learning from Experience--How Development Projects Spread "Good Practice" in Britain.

ERIC Educational Resources Information Center

Clynes, Roger

1992-01-01

Architects and Buildings Branch (A&B) of Department of Education in London, England, is specifically responsible for design and management of educational facilities. Current development project provides example of emphasis, aims, methods of work, and outcome of a typical project. Fact file on British public schools and list of type of reports…

21 CFR 225.102 - Master record file and production records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Master record file and production records. 225.102 Section 225.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225...

21 CFR 225.102 - Master record file and production records.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Master record file and production records. 225.102 Section 225.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225...