76 FR 72674 - Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 29F, Hitachi Automotive...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-25

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1798] Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 29F, Hitachi Automotive Systems Americas, Inc., (Automotive... requested an expansion of the scope of manufacturing authority on behalf of Hitachi Automotive Systems...

76 FR 80886 - Approval for Manufacturing Authority; Foreign-Trade Zone 26; Makita Corporation of America; (Hand...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1803] Approval for Manufacturing Authority; Foreign-Trade Zone 26; Makita Corporation of America; (Hand-Held/Stationary Power Tool and Gasoline/Electric-Powered Lawn and Garden Product Manufacturing); Buford, GA Pursuant to its authority...

77 FR 16537 - Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 78A, Nissan North...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1820] Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 78A, Nissan North America, Inc. (Electric Passenger Vehicles..., Nissan North America, Inc. (NNA), operator of Subzone 78A, at the NNA manufacturing facilities in Smyrna...

Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not Requiring Competent Authority Design Approval - 13282

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

Komann, Steffen; Groeke, Carsten; Droste, Bernhard

The majority of transports of radioactive materials are carried out in packages which don't need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP's leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the 'non-competent authority approved package types' are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment bymore » the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, Chap. 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the 'regulatory density' for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 chap. 801 requires documentary verification by the consignor concerning package compliance with the requirements. (authors)« less

21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

Code of Federal Regulations, 2010 CFR

2010-04-01

... mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510... copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new... medicated feed mill license (Form FDA 3448) on the premises of the manufacturing establishment; and (b...

Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions.

PubMed

Hassett, Brian; Singh, Ena; Mahgoub, Ehab; O'Brien, Julie; Vicik, Steven M; Fitzpatrick, Brian

2018-01-01

Etanercept (ETN) (Enbrel®) is a soluble protein that binds to, and specifically inhibits, tumor necrosis factor (TNF), a proinflammatory cytokine. ETN is synthesized in Chinese hamster ovary cells by recombinant DNA technology as a fusion protein, with a fully human TNFRII ectodomain linked to the Fc portion of human IgG1. Successful manufacture of biologics, such as ETN, requires sophisticated process and product understanding, as well as meticulous control of operations to maintain product consistency. The objective of this evaluation was to show that the product profile of ETN drug substance (DS) has been consistent over the course of production. Multiple orthogonal biochemical analyses, which included evaluation of attributes indicative of product purity, potency, and quality, were assessed on >2,000 batches of ETN from three sites of DS manufacture, during the period 1998-2015. Based on the key quality attributes of product purity (assessed by hydrophobic interaction chromatography HPLC), binding activity (to TNF by ELISA), potency (inhibition of TNF-induced apoptosis by cell-based bioassay) and quality (N-linked oligosaccharide map), we show that the integrity of ETN DS has remained consistent over time. This consistency was maintained through three major enhancements to the initial process of manufacturing that were supported by detailed comparability assessments, and approved by the European Medicines Agency. Examination of results for all major quality attributes for ETN DS indicates a highly consistent process for over 18 years and throughout changes to the manufacturing process, without affecting safety and efficacy, as demonstrated across a wide range of clinical trials of ETN in multiple inflammatory diseases.

78 FR 16247 - Approval for Export-Only Manufacturing Authority, Foreign-Trade Zone 203, SGL Automotive Carbon...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-14

... Manufacturing Authority, Foreign-Trade Zone 203, SGL Automotive Carbon Fibers, LLC, (Carbon Fiber Manufacturing... SGL Automotive Carbon Fibers, LLC, within FTZ 203-Site 3, in Moses Lake, Washington (FTZ Docket 4-2011... Carbon Fibers, LLC, as described in the application and Federal Register notice, is approved, subject to...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

24 CFR 982.621 - Manufactured home: Housing quality standards.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

78 FR 55057 - Authority To Manufacture Carbon Fiber for the U.S. Market Not Approved; Foreign-Trade Subzone...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-09

... behalf of Toho Tenax America, Inc. (TTA), to manufacture carbon fiber under zone procedures for the U.S... approve the application requesting authority to manufacture carbon fiber for the U.S. market under zone... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1914] Authority To Manufacture Carbon...

77 FR 75609 - Approval for Manufacturing Authority; Foreign-Trade Zone 277; Suntech Arizona, Inc. (Solar Panel...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1873] Approval for Manufacturing Authority; Foreign-Trade Zone 277; Suntech Arizona, Inc. (Solar Panel Manufacturing); Goodyear, AZ Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u...

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

PubMed

Burcham, Christopher L; Florence, Alastair J; Johnson, Martin D

2018-06-07

The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

77 FR 6536 - Approval for Manufacturing Authority; Foreign-Trade Zone 177; Best Chair, Inc., d/b/a Best Home...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-08

... manufacturing authority on behalf of Best Chair, Inc., d/ b/a Best Home Furnishings, Inc., within FTZ 177 in... application for manufacturing authority under zone procedures within FTZ 177 on behalf of Best Chair, Inc., d... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1807] Approval for Manufacturing...

Quality cell therapy manufacturing by design.

PubMed

Lipsitz, Yonatan Y; Timmins, Nicholas E; Zandstra, Peter W

2016-04-01

Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

30 CFR 28.32 - Proposed quality control plans; approval by MSHA.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Proposed quality control plans; approval by...-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.32 Proposed quality control plans; approval by MSHA. (a) Each proposed quality control plan submitted in accordance with this...

30 CFR 28.32 - Proposed quality control plans; approval by MSHA.

Code of Federal Regulations, 2012 CFR

2012-07-01

...-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.32 Proposed quality control plans; approval by MSHA. (a) Each proposed quality control plan submitted in accordance with this... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Proposed quality control plans; approval by...

30 CFR 28.32 - Proposed quality control plans; approval by MSHA.

Code of Federal Regulations, 2013 CFR

2013-07-01

...-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.32 Proposed quality control plans; approval by MSHA. (a) Each proposed quality control plan submitted in accordance with this... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Proposed quality control plans; approval by...

30 CFR 28.32 - Proposed quality control plans; approval by MSHA.

Code of Federal Regulations, 2014 CFR

2014-07-01

...-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.32 Proposed quality control plans; approval by MSHA. (a) Each proposed quality control plan submitted in accordance with this... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Proposed quality control plans; approval by...

77 FR 24177 - Approval for Manufacturing Authority; Foreign-Trade Zone 177; Hoosier Stamping & Mfg. Corp...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-23

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1822] Approval for Manufacturing Authority; Foreign-Trade Zone 177; Hoosier Stamping & Mfg. Corp. (Wheel Assemblies and Accessories); Chandler, IN Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U...

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.21 EPA review and approval of water quality standards. (a) After the State submits its... analysis. (b) The Regional Administrator's approval or disapproval of a State water quality standard shall...

15 CFR 400.32 - Procedure for review of request for approval of manufacturing or processing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Procedure for review of request for approval of manufacturing or processing. 400.32 Section 400.32 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) FOREIGN-TRADE ZONES BOARD, DEPARTMENT OF COMMERCE...

75 FR 14128 - Approval for Manufacturing Authority, Foreign-Trade Zone 7, CooperVision Caribbean Corporation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1669] Approval for Manufacturing Authority, Foreign-Trade Zone 7, CooperVision Caribbean Corporation (Contact Lenses), Juana Diaz, Puerto Rico Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C...

The vital role of manufacturing quality in the reliability of PV modules

NASA Astrophysics Data System (ADS)

Rusch, Peter

2014-10-01

The influence of manufacturing quality on the reliability of PV modules coming out of today's factories has been, and is still, under estimated among investors and buyers. The main reason is perception. Contrary to popular belief, PV modules are not a commodity. Module quality does differ among module brands. Certification alone does not guarantee the quality or reliability of a module. Cost reductions in manufacturing have unequivocally affected module quality. And the use of new, cheaper materials has had a measureable impact on module reliability. The need for meaningful manufacturing quality standards has been understood by the leading technical institutions and important industry players. The fact that most leading PV panel manufacturers have been certified according to ISO 9001 has led to some level of improvement and higher effectiveness. The new ISO 9001 PV QMS standards will be a major step in providing a tool to assess PV manufacturers' quality management systems. The current lack of sufficient standards has still got a negative influence on the quality of modules being installed today. Today every manufacturer builds their modules in their own way with little standardization or adherence to quality processes and methods, which are commonplace in other manufacturing industries. Although photovoltaic technology is to a great extent mature, the way modules are being produced has changed significantly over the past few years and it continues to change at a rapid pace. Investors, financiers and lenders stand the most to gain from PV systems over the long-term, but also the most to lose. Investors, developers, EPC, O&M and solar asset management companies must all manage manufacturing quality more proactively or they will face unexpected risks and failures down the road. Manufacturing quality deserves more transparency and attention, as it is a major driver of module performance and reliability. This paper will explain the benefits of good manufacturing

76 FR 67406 - Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 158D Nissan North America...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1794] Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 158D Nissan North America, Inc.; (Motor Vehicles) Canton, MS...), the Foreign-Trade Zones Board (the Board) adopts the following Order. Whereas, Nissan North America...

77 FR 60672 - Approval for Manufacturing Authority, Foreign-Trade Zone 99, Fisker Automotive, Inc., (Electric...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-04

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1860] Approval for Manufacturing Authority, Foreign-Trade Zone 99, Fisker Automotive, Inc., (Electric Passenger Vehicles), Wilmington, DE Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u...

[Interchangeability of biological drugs: considerations about the approval of biogeneric formulations in Chile].

PubMed

Saavedra S, Iván; Quiñones S, Luis

2006-12-01

Once drug patents expire, the health authorities can approve the registry of similar products. They must request to the manufacturer, the bibliographic background of the original product and the analytical results that certify drug quality. An inspection of the premises of the manufacturer is also required. The main goal of this approval is to decrease cost, considering that the original product is usually more expensive. This is a current situation due to the imminent expiration of the patents of many biopharmaceutical products. Therefore, in Chile, the Public Health (ISP) and the Ministry of Health should consider that for this kind of products, until now, there are no interchangeable generic drugs, and that the similar drugs that are offered have a different chemical composition, since they have been manufactured through different processes. In the case of biological drugs (e.g. erythropoietir, somatotropin, heparin) the quality and homogeneity depend from the manufacture process. Its complete composition can not be absolutely elucidated; therefore small impurities or conformational variants can elicit an altered immune response or unexpected adverse reactions. This indicates that the approval of a biogeneric drug requires in addition to pharmacokinetic studies, preclinical and clinical analytical studies such as physicochemical assays, biological and immunological test. This issues have been established by WHO and have been incorporated for the main drug registry entities all over the world (FDA, EMEA, ANVISA) to approve biogeneric products.

MapReduce Based Parallel Bayesian Network for Manufacturing Quality Control

NASA Astrophysics Data System (ADS)

Zheng, Mao-Kuan; Ming, Xin-Guo; Zhang, Xian-Yu; Li, Guo-Ming

2017-09-01

Increasing complexity of industrial products and manufacturing processes have challenged conventional statistics based quality management approaches in the circumstances of dynamic production. A Bayesian network and big data analytics integrated approach for manufacturing process quality analysis and control is proposed. Based on Hadoop distributed architecture and MapReduce parallel computing model, big volume and variety quality related data generated during the manufacturing process could be dealt with. Artificial intelligent algorithms, including Bayesian network learning, classification and reasoning, are embedded into the Reduce process. Relying on the ability of the Bayesian network in dealing with dynamic and uncertain problem and the parallel computing power of MapReduce, Bayesian network of impact factors on quality are built based on prior probability distribution and modified with posterior probability distribution. A case study on hull segment manufacturing precision management for ship and offshore platform building shows that computing speed accelerates almost directly proportionally to the increase of computing nodes. It is also proved that the proposed model is feasible for locating and reasoning of root causes, forecasting of manufacturing outcome, and intelligent decision for precision problem solving. The integration of bigdata analytics and BN method offers a whole new perspective in manufacturing quality control.

Marketing Approval of Ethical Kampo Medicines.

PubMed

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

76 FR 28418 - Approval for Manufacturing Authority, Foreign-Trade Zone 104; Mitsubishi Power Systems Americas...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-17

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1757] Approval for Manufacturing Authority, Foreign-Trade Zone 104; Mitsubishi Power Systems Americas, Inc., (Power Generation Turbine Components), Pooler, GA Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade...

78 FR 10129 - Approval for Expansion of Manufacturing Authority; Foreign-Trade Zone 104; Mitsubishi Power...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1883] Approval for Expansion of Manufacturing Authority; Foreign-Trade Zone 104; Mitsubishi Power Systems Americas, Inc. (Power Generation Turbines); Pooler, GA Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trad...

78 FR 58273 - Approval for Manufacturing (Production) Authority, Foreign-Trade Zone 284, Liberty Pumps, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1915] Approval for Manufacturing (Production) Authority, Foreign-Trade Zone 284, Liberty Pumps, Inc. (Submersible and Water Pumps), Bergen, New York Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Boar...

78 FR 63877 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

...] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection... ambient air quality standard (NAAQS). EPA is approving this SIP revision in accordance with the...

77 FR 73414 - Approval for Expansion of Manufacturing Authority; Foreign-Trade Subzone 41H; Mercury Marine...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-10

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1871] Approval for Expansion of Manufacturing Authority; Foreign-Trade Subzone 41H; Mercury Marine (Marine Propulsion Products); Fond du Lac and Oshkosh, WI Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U...

30 CFR 22.10 - Approval plate.

Code of Federal Regulations, 2010 CFR

2010-07-01

... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by manufacturers. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible methane... follows: Permissible Methane Detector (or Permissible Methane Indicating Detector) Approval No. ___ issued...

Approved Air Quality Implementation Plans in Region 10

EPA Pesticide Factsheets

Landing page for information about EPA-approved air quality State Implementation Plans (SIPs), Tribal Implementation Plans (TIPs), and Federal Implementation Plans (FIPs) in Alaska, Idaho, Oregon, Washington.

Supplements and other changes to an approved application. Final rule.

PubMed

2004-04-08

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 23 2013-07-01 2013-07-01 false EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 22 2014-07-01 2013-07-01 true EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 23 2012-07-01 2012-07-01 false EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 22 2011-07-01 2011-07-01 false EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

78 FR 55056 - Approval for Manufacturing (Production) Authority; Foreign-Trade Zone 141; Firth Rixson, Inc. d/b...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-09

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1913] Approval for Manufacturing (Production) Authority; Foreign-Trade Zone 141; Firth Rixson, Inc. d/b/a Firth Rixson Monroe (Aircraft Turbine Components); Rochester, New York Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934...

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

PubMed

Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

2017-09-18

Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

Precision manufacturing for clinical-quality regenerative medicines.

PubMed

Williams, David J; Thomas, Robert J; Hourd, Paul C; Chandra, Amit; Ratcliffe, Elizabeth; Liu, Yang; Rayment, Erin A; Archer, J Richard

2012-08-28

Innovations in engineering applied to healthcare make a significant difference to people's lives. Market growth is guaranteed by demographics. Regulation and requirements for good manufacturing practice-extreme levels of repeatability and reliability-demand high-precision process and measurement solutions. Emerging technologies using living biological materials add complexity. This paper presents some results of work demonstrating the precision automated manufacture of living materials, particularly the expansion of populations of human stem cells for therapeutic use as regenerative medicines. The paper also describes quality engineering techniques for precision process design and improvement, and identifies the requirements for manufacturing technology and measurement systems evolution for such therapies.

77 FR 52277 - Approval of Air Quality Implementation Plans; California; South Coast Air Quality Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-29

... Quality Implementation Plans; California; South Coast Air Quality Management District; Prevention of... rule. SUMMARY: EPA is proposing approval of a permitting rule submitted for the South Coast Air Quality Management District (District) portion of the California State Implementation Plan (SIP). The State is...

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam

2018-04-05

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field. Copyright © 2018 Elsevier B.V. All rights reserved.

Using quality experts from manufacturing to transform primary care.

PubMed

Steiner, Rose M; Walsworth, David T

2010-01-01

Improving Performance in Practice (IPIP) is an initiative convened by the American Board of Medical Specialties. It investigates the efficacy of coaches in helping primary-care practices improve the care of patients with diabetes and asthma. Most IPIP states use coaches who have a health care background, and are trained in quality and process improvement. Michigan uses quality experts from the manufacturing industry who are educated regarding the health care environment, which enables them to perform as quality-improvement coaches (QICs) in primary-care practices. In this case study, ninety-six quality experts were trained to coach primary-care practices, with 53 currently assigned to offices, and others assisting as needed. Practice teams and QICs identify gaps in care and office practices with the use of assorted quality-improvement tools. Reports are made monthly to describe clinical and process measures and methods used. Michigan has 33 practices engaged, involving 205 physicians and 40 midlevel providers. The teaming of quality experts from the manufacturing industry with primary-care office providers and staff resulted in office efficiency, improved care provided, and progress toward attainment of a patient-centered medical home (PCMH). Quality experts from manufacturing volunteered to coach for improvements in primary care. The efforts of QICs have been successful. Because the QICs are volunteers, sustainability of the Michigan Improving Performance in Practice program is a challenge.

Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.

PubMed

O'Connor, Thomas F; Yu, Lawrence X; Lee, Sau L

2016-07-25

Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include: (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies. Published by Elsevier B.V.

78 FR 63878 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revised Ambient Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

...] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revised Ambient Air Quality... State Implementation Plan (SIP). The revisions add ambient air quality standards and associated... Ambient Air Quality Standards (NAAQS) for PM 2.5 . EPA is approving these revisions in accordance with the...

46 CFR 175.800 - Approved equipment and material.

Code of Federal Regulations, 2011 CFR

2011-10-01

... required by this subchapter to be approved or of an approved type, must have been manufactured and approved... Accepted under Marine Inspection and Navigation Laws” lists approved equipment by type and manufacturer. COMDTINST M16714.3 (Series) may be obtained from New Orders, Superintendent of Documents, P.O. Box 371954...

46 CFR 175.800 - Approved equipment and material.

Code of Federal Regulations, 2010 CFR

2010-10-01

... required by this subchapter to be approved or of an approved type, must have been manufactured and approved... Accepted under Marine Inspection and Navigation Laws” lists approved equipment by type and manufacturer. COMDTINST M16714.3 (Series) may be obtained from New Orders, Superintendent of Documents, P.O. Box 371954...

78 FR 63934 - Approval of Air Quality Implementation Plans; California; El Dorado County Air Quality Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

...] Approval of Air Quality Implementation Plans; California; El Dorado County Air Quality Management District... California for the El Dorado County Air Quality Management District (EDAQMD) portion of the California SIP... 24, 1987 Federal Register, May 25, 1988, U.S. EPA, Air Quality Management Division, Office of Air...

78 FR 19990 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Ohio Ambient Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-03

... Promulgation of Air Quality Implementation Plans; Ohio; Ohio Ambient Air Quality Standards; Correction AGENCY... approved revisions to Ohio regulations that consolidated air quality standards in a new chapter of rules... State's air quality standards into Ohio Administrative Code (OAC) 3745-25 and modifying an assortment of...

Discrete State Change Model of Manufacturing Quality to Aid Assembly Process Design

NASA Astrophysics Data System (ADS)

Koga, Tsuyoshi; Aoyama, Kazuhiro

This paper proposes a representation model of the quality state change in an assembly process that can be used in a computer-aided process design system. In order to formalize the state change of the manufacturing quality in the assembly process, the functions, operations, and quality changes in the assembly process are represented as a network model that can simulate discrete events. This paper also develops a design method for the assembly process. The design method calculates the space of quality state change and outputs a better assembly process (better operations and better sequences) that can be used to obtain the intended quality state of the final product. A computational redesigning algorithm of the assembly process that considers the manufacturing quality is developed. The proposed method can be used to design an improved manufacturing process by simulating the quality state change. A prototype system for planning an assembly process is implemented and applied to the design of an auto-breaker assembly process. The result of the design example indicates that the proposed assembly process planning method outputs a better manufacturing scenario based on the simulation of the quality state change.

21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

Approved Air Quality Implementation Plans in The Virgin Islands

EPA Pesticide Factsheets

This site contains information about air quality regulations called State Implementation Plans (SIPs), Federal Implementation Plans (FIPs), and Tribal Implementation Plans (TIPs) approved by EPA within the U.S. Virgin Islands.

21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS Records and Reports § 510.305 Maintenance of...

Manufacture and quality control of interconnecting wire hardnesses, Volume 1

NASA Technical Reports Server (NTRS)

1972-01-01

A standard is presented for manufacture, installation, and quality control of eight types of interconnecting wire harnesses. The processes, process controls, and inspection and test requirements reflected are based on acknowledgment of harness design requirements, acknowledgment of harness installation requirements, identification of the various parts, materials, etc., utilized in harness manufacture, and formulation of a typical manufacturing flow diagram for identification of each manufacturing and quality control process, operation, inspection, and test. The document covers interconnecting wire harnesses defined in the design standard, including type 1, enclosed in fluorocarbon elastomer convolute, tubing; type 2, enclosed in TFE convolute tubing lines with fiberglass braid; type 3, enclosed in TFE convolute tubing; and type 5, combination of types 3 and 4. Knowledge gained through experience on the Saturn 5 program coupled with recent advances in techniques, materials, and processes was incorporated.

[Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine].

PubMed

Xu, Bing; Shi, Xin-Yuan; Wu, Zhi-Sheng; Zhang, Yan-Ling; Wang, Yun; Qiao, Yan-Jiang

2017-03-01

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness. Copyright© by the Chinese Pharmaceutical Association.

78 FR 16826 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Cleveland-Akron-Lorain and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

...-9790-1] Approval and Promulgation of Air Quality Implementation Plans; Ohio; Cleveland-Akron-Lorain and Columbus 1997 8-Hour Ozone Maintenance Plan Revisions to Approved Motor Vehicle Emissions Budgets AGENCY... quality State Implementation Plans (SIPs) under the Clean Air Act to replace the previously approved motor...

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

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

19 CFR 115.32 - Approval plates.

Code of Federal Regulations, 2012 CFR

2012-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.32 Approval plates. The manufacturer shall affix, in a clearly visible place on or near one of the doors or other main openings of each container manufactured to...

19 CFR 115.32 - Approval plates.

Code of Federal Regulations, 2013 CFR

2013-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.32 Approval plates. The manufacturer shall affix, in a clearly visible place on or near one of the doors or other main openings of each container manufactured to...

19 CFR 115.32 - Approval plates.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.32 Approval plates. The manufacturer shall affix, in a clearly visible place on or near one of the doors or other main openings of each container manufactured to...

19 CFR 115.32 - Approval plates.

Code of Federal Regulations, 2011 CFR

2011-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.32 Approval plates. The manufacturer shall affix, in a clearly visible place on or near one of the doors or other main openings of each container manufactured to...

19 CFR 115.32 - Approval plates.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.32 Approval plates. The manufacturer shall affix, in a clearly visible place on or near one of the doors or other main openings of each container manufactured to...

30 CFR 28.32 - Proposed quality control plans; approval by MSHA.

Code of Federal Regulations, 2010 CFR

2010-07-01

... subpart shall be reviewed by MSHA to determine its effectiveness in insuring the quality of short-circuit... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.32 Proposed quality control...

Long-term quality assurance of [(18)F]-fluorodeoxyglucose (FDG) manufacturing.

PubMed

Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

2016-01-01

Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of (18)F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade "A" isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade "A" isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [(18)F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems.

Long-term quality assurance of [18F]-fluorodeoxyglucose (FDG) manufacturing

PubMed Central

Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

2016-01-01

Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of 18F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade “A” isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade “A” isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [18F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems. PMID:27508102

78 FR 50369 - Approval and Promulgation of Air Quality Implementation Plans; Michigan

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

...] Approval and Promulgation of Air Quality Implementation Plans; Michigan AGENCY: Environmental Protection... the State of Michigan's Clean Air Act State Implementation Plan (SIP) that Michigan had submitted on March 24, 2009. Michigan's submittal included revisions to Part 1, Definitions; Part 2, Air Use Approval...

Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.

PubMed

Wuchter, Patrick; Bieback, Karen; Schrezenmeier, Hubert; Bornhäuser, Martin; Müller, Lutz P; Bönig, Halvard; Wagner, Wolfgang; Meisel, Roland; Pavel, Petra; Tonn, Torsten; Lang, Peter; Müller, Ingo; Renner, Matthias; Malcherek, Georg; Saffrich, Rainer; Buss, Eike C; Horn, Patrick; Rojewski, Markus; Schmitt, Anita; Ho, Anthony D; Sanzenbacher, Ralf; Schmitt, Michael

2015-02-01

Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process. This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production. The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs. This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

14 CFR 21.307 - Quality system.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Quality system. 21.307 Section 21.307... PROCEDURES FOR PRODUCTS AND PARTS Parts Manufacturer Approvals § 21.307 Quality system. Each applicant for or holder of a PMA must establish a quality system that meets the requirements of § 21.137. ...

Capability approval programme for Microwave Hybrid Integrated Circuits (MHICS)

NASA Astrophysics Data System (ADS)

1990-11-01

The general requirements for capability approval of a manufacturing line for Microwave Hybrid Integrated Circuits (MHICs) are defined. ESA approval mandate will be exercized upon conclusion of the evaluation phase and at the end of the program. Before the evaluation phase can commence, the manufacturer must define the capability approval domain by specifying the processes, materials and technology for which approval is sought.

Bioengineering Solutions for Manufacturing Challenges in CAR T Cells

PubMed Central

Piscopo, Nicole J.; Mueller, Katherine P.; Das, Amritava; Hematti, Peiman; Murphy, William L.; Palecek, Sean P.; Capitini, Christian M.

2017-01-01

The next generation of therapeutic products to be approved for the clinic is anticipated to be cell therapies, termed “living drugs” for their capacity to dynamically and temporally respond to changes during their production ex vivo and after their administration in vivo. Genetically engineered chimeric antigen receptor (CAR) T cells have rapidly developed into powerful tools to harness the power of immune system manipulation against cancer. Regulatory agencies are beginning to approve CAR T cell therapies due to their striking efficacy in treating some hematological malignancies. However, the engineering and manufacturing of such cells remains a challenge for widespread adoption of this technology. Bioengineering approaches including biomaterials, synthetic biology, metabolic engineering, process control and automation, and in vitro disease modeling could offer promising methods to overcome some of these challenges. Here, we describe the manufacturing process of CAR T cells, highlighting potential roles for bioengineers to partner with biologists and clinicians to advance the manufacture of these complex cellular products under rigorous regulatory and quality control. PMID:28840981

78 FR 54813 - Approval and Promulgation of Air Quality Implementation Plans; Maine; Oxides of Nitrogen...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 [EPA-R01-OAR-2012-0895; FRL- 9900-85-Region1] Approval and Promulgation of Air Quality Implementation Plans; Maine; Oxides of Nitrogen Exemption and... proposed Approval and Promulgation of Air Quality Implementation Plans; Maine; Oxides of Nitrogen Exemption...

49 CFR 178.70 - Approval of UN pressure receptacles.

Code of Federal Regulations, 2012 CFR

2012-10-01

... designee. (b) IIA pre-audit. The manufacturer must submit an application for initial design type approval... of the manufacturer and the IIA certifying the design type, the test results, chemical analyses, lot... initial design type approval. If the pre-audit is found satisfactory by the IIA, the manufacturer will...

49 CFR 178.70 - Approval of UN pressure receptacles.

Code of Federal Regulations, 2011 CFR

2011-10-01

... designee. (b) IIA pre-audit. The manufacturer must submit an application for initial design type approval... of the manufacturer and the IIA certifying the design type, the test results, chemical analyses, lot... initial design type approval. If the pre-audit is found satisfactory by the IIA, the manufacturer will...

49 CFR 178.70 - Approval of UN pressure receptacles.

Code of Federal Regulations, 2014 CFR

2014-10-01

... designee. (b) IIA pre-audit. The manufacturer must submit an application for initial design type approval... of the manufacturer and the IIA certifying the design type, the test results, chemical analyses, lot... initial design type approval. If the pre-audit is found satisfactory by the IIA, the manufacturer will...

49 CFR 178.70 - Approval of UN pressure receptacles.

Code of Federal Regulations, 2013 CFR

2013-10-01

... designee. (b) IIA pre-audit. The manufacturer must submit an application for initial design type approval... of the manufacturer and the IIA certifying the design type, the test results, chemical analyses, lot... initial design type approval. If the pre-audit is found satisfactory by the IIA, the manufacturer will...

78 FR 76064 - Approval and Promulgation of Air Quality Implementation Plans; Michigan

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-16

...] Approval and Promulgation of Air Quality Implementation Plans; Michigan AGENCY: Environmental Protection... nonattainment air quality permitting regulations found in 40 CFR 51.165(a) and (b). EPA has found that the rules... progress toward achieving the National Ambient Air Quality Standards. II. Statutory and Executive Order...

Total quality through computer integrated manufacturing in the pharmaceutical industry.

PubMed

Ufret, C M

1995-01-01

The role of Computer Integrated Manufacturing (CIM) in the pursue of total quality in pharmaceutical manufacturing is assessed. CIM key objectives, design criteria, and performance measurements, in addition to its scope and implementation in a hierarchical structure, are explored in detail. Key elements for the success of each phase in a CIM project and a brief status of current CIM implementations in the pharmaceutical industry are presented. The role of World Class Manufacturing performance standards and other key issues to achieve full CIM benefits are also addressed.

77 FR 64445 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Greif Packaging, LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... applies to emissions of volatile organic matter (VOM) from Greif's fiber drum container manufacturing facility. VOM, as defined by the State of Illinois, is identical to volatile organic compound, as defined... Environmental Protection Agency submitted to EPA for approval an adjustment to the general rule, Organic...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

19 CFR 115.63 - Application for approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of the design type and the serial number of the vehicle in the type series manufacturer's number; and... Procedures for Approval of Road Vehicles by Design Type § 115.63 Application for approval. Each application by a manufacturer for certification of a road vehicle by design type must include: (a) Three copies...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

77 FR 64039 - Limited Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-18

... Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County; Stationary Source... limited approval and limited disapproval of revisions to the Clark County portion of the applicable state... limited approval and limited disapproval action is to update the applicable SIP with current Clark County...

Total Quality Management in Space Shuttle Main Engine manufacturing

NASA Technical Reports Server (NTRS)

Ding, J.

1992-01-01

The Total Quality Management (TQM) philosophy developed in the Marshall Space Flight Center (MSFC) is briefly reviewed and the ongoing TQM implementation effort which is being pursued through the continuous improvement (CI) process is discussed. TQM is based on organizational excellence which integrates the new supportive culture with the technical tools necessary to identify, assess, and correct manufacturing processes. Particular attention is given to the prime contractor's change to the organizational excellence management philosophy in SSME manufacturing facilities.

78 FR 49409 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

...] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection... national ambient air quality standards (NAAQS) are promulgated, the CAA requires states to submit a plan...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2012 CFR

2012-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2013 CFR

2013-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2011 CFR

2011-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2014 CFR

2014-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.105 - What must quality control personnel do?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What must quality control personnel do? 111.105... for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must... manufacturing record. To do so, quality control personnel must perform operations that include: (a) Approving or...

78 FR 53709 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-30

...] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure Requirements for the 2008 Ozone National Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA... ambient air quality standards (NAAQS) are promulgated, the CAA requires states to submit a plan for the...

Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

2015-03-01

drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

19 CFR 115.42 - Approval plates.

Code of Federal Regulations, 2011 CFR

2011-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

19 CFR 115.42 - Approval plates.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

19 CFR 115.42 - Approval plates.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

19 CFR 115.42 - Approval plates.

Code of Federal Regulations, 2013 CFR

2013-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

19 CFR 115.42 - Approval plates.

Code of Federal Regulations, 2012 CFR

2012-04-01

... CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.42 Approval plates. (a) The owner or operator... plate in the manner specified for containers approved by design type (see § 115.32). (b) Although an...

78 FR 70497 - Approval and Promulgation of Air Quality Implementation Plans; Illinois

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-26

...] Approval and Promulgation of Air Quality Implementation Plans; Illinois AGENCY: Environmental Protection... VOC for purposes of preparing SIPs to attain the national ambient air quality standard for ozone [email protected] . 3. Fax: (312) 692-2450. 4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air...

78 FR 54813 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Construction Permit...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

...] Approval and Promulgation of Air Quality Implementation Plans; Colorado; Construction Permit Program Fee Increases; Construction Permit Regulation of PM 2.5 ; Regulation 3 AGENCY: Environmental Protection Agency... construction permit processing fees. EPA proposes approval of Colorado's May 25, 2011 submittal, which...

46 CFR 160.054-7 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall furnish... forwarding to the Commandant. (b) Pre-approval sample. After the first drawings have been examined and found..., prepaid by the manufacturer, to the Commandant for the necessary conditioning and tests in accordance with...

Monitoring system for the quality assessment in additive manufacturing

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

Carl, Volker, E-mail: carl@t-zfp.de

Additive Manufacturing (AM) refers to a process by which a set of digital data -representing a certain complex 3dim design - is used to grow the respective 3dim real structure equal to the corresponding design. For the powder-based EOS manufacturing process a variety of plastic and metal materials can be used. Thereby, AM is in many aspects a very powerful tool as it can help to overcome particular limitations in conventional manufacturing. AM enables more freedom of design, complex, hollow and/or lightweight structures as well as product individualisation and functional integration. As such it is a promising approach with respectmore » to the future design and manufacturing of complex 3dim structures. On the other hand, it certainly calls for new methods and standards in view of quality assessment. In particular, when utilizing AM for the design of complex parts used in aviation and aerospace technologies, appropriate monitoring systems are mandatory. In this respect, recently, sustainable progress has been accomplished by joining the common efforts and concerns of a manufacturer Additive Manufacturing systems and respective materials (EOS), along with those of an operator of such systems (MTU Aero Engines) and experienced application engineers (Carl Metrology), using decent know how in the field of optical and infrared methods regarding non-destructive-examination (NDE). The newly developed technology is best described by a high-resolution layer by layer inspection technique, which allows for a 3D tomography-analysis of the complex part at any time during the manufacturing process. Thereby, inspection costs are kept rather low by using smart image-processing methods as well as CMOS sensors instead of infrared detectors. Moreover, results from conventional physical metallurgy may easily be correlated with the predictive results of the monitoring system which not only allows for improvements of the AM monitoring system, but finally leads to an optimisation of the

Monitoring system for the quality assessment in additive manufacturing

NASA Astrophysics Data System (ADS)

Carl, Volker

2015-03-01

Additive Manufacturing (AM) refers to a process by which a set of digital data -representing a certain complex 3dim design - is used to grow the respective 3dim real structure equal to the corresponding design. For the powder-based EOS manufacturing process a variety of plastic and metal materials can be used. Thereby, AM is in many aspects a very powerful tool as it can help to overcome particular limitations in conventional manufacturing. AM enables more freedom of design, complex, hollow and/or lightweight structures as well as product individualisation and functional integration. As such it is a promising approach with respect to the future design and manufacturing of complex 3dim structures. On the other hand, it certainly calls for new methods and standards in view of quality assessment. In particular, when utilizing AM for the design of complex parts used in aviation and aerospace technologies, appropriate monitoring systems are mandatory. In this respect, recently, sustainable progress has been accomplished by joining the common efforts and concerns of a manufacturer Additive Manufacturing systems and respective materials (EOS), along with those of an operator of such systems (MTU Aero Engines) and experienced application engineers (Carl Metrology), using decent know how in the field of optical and infrared methods regarding non-destructive-examination (NDE). The newly developed technology is best described by a high-resolution layer by layer inspection technique, which allows for a 3D tomography-analysis of the complex part at any time during the manufacturing process. Thereby, inspection costs are kept rather low by using smart image-processing methods as well as CMOS sensors instead of infrared detectors. Moreover, results from conventional physical metallurgy may easily be correlated with the predictive results of the monitoring system which not only allows for improvements of the AM monitoring system, but finally leads to an optimisation of the quality

76 FR 48002 - Approval and Promulgation of Air Quality Implementation Plans; State of California; Interstate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...EPA is finalizing a limited approval and limited disapproval of a state implementation plan (SIP) revision submitted by the State of California on November 17, 2007, to address the ``transport SIP'' provisions of Clean Air Act (CAA) section 110(a)(2)(D)(i) for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS or standards) and the 1997 fine particulate matter (PM2.5) NAAQS. Section 110(a)(2)(D)(i) of the CAA requires that each SIP contain, among other things, adequate measures prohibiting emissions of air pollutants in amounts which will interfere with any other State's measures required under title I, part C of the CAA to prevent significant deterioration of air quality. EPA is approving California's SIP revision with respect to those Districts that implement SIP- approved permit programs meeting the approval criteria and simultaneously disapproving California's SIP revision with respect to those Districts that do not implement SIP-approved permit programs meeting the approval criteria, as discussed in our May 31, 2011 proposed rule (76 FR 31263).

14 CFR 21.269 - Export airworthiness approvals.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Export airworthiness approvals. 21.269 Section 21.269 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION....269 Export airworthiness approvals. The manufacturer may issue export airworthiness approvals. ...

14 CFR 21.269 - Export airworthiness approvals.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.269 Section 21.269 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION....269 Export airworthiness approvals. The manufacturer may issue export airworthiness approvals. ...

75 FR 8292 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Opacity Source...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2010-0009; FRL-9115-8] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Opacity Source Surveillance Methods AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA proposes to approve the State...

The Impact of Soft Factors on Quality Improvement in Manufacturing Industry

NASA Astrophysics Data System (ADS)

Chan, Shiau Wei; Fauzi Ahmad, Md; Kong, Mei Wan

2017-08-01

Nowadays, soft factors have become the key factors of success in quality improvement of an organisation. Many organisations have neglected the importance of soft factors, this may influence the organisational performance. Hence, the purpose of this research is to examine the impact of soft factors on quality improvement in manufacturing industries. Six hypotheses were examined while considering six dimensions of soft factors including management commitment, customer focus, supplier relationship, employee involvement, training and education, and reward and recognition that have a positive impact on quality improvement. In this study, eighty one managers from the quality department were randomly selected in the manufacturing industry in Batu Pahat, Johor. The questionnaires were distributed to them. The researcher analysed the quantitatively collected data using descriptive analysis and correlation analysis. The findings of this study revealed that all soft factors are correlated to the quality improvement in an organisation with a high significant value but the regression analysis shows that the supplier relationship and employee involvement has more significant impact on quality improvement as compared to other soft factors which contributes of this study.

78 FR 65593 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Infrastructure...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-01

...] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Infrastructure Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection... revised national ambient air quality standards (NAAQS) are promulgated, the CAA requires states to submit...

78 FR 75902 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Philadelphia County...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-13

...] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Philadelphia County Reasonably Available Control Technology Under the 1997 8-Hour Ozone National Ambient Air Quality Standard AGENCY... Department of Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

77 FR 31727 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2012-0073; FRL 9677-3] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container Exemption From VOC Coating Rules...), direct final rule approving a revision to the Illinois SIP that added a ``small container exemption'' for...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

75 FR 2090 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Volatile Organic Compound...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-14

... Promulgation of Air Quality Implementation Plans; Indiana; Volatile Organic Compound Automobile Refinishing... automobile refinishing rule for approval into its State Implementation Plan (SIP). These rule revisions extend the applicability of Indiana's approved volatile organic compound (VOC) automobile refinishing...

Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

2015-03-01

drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

77 FR 48061 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Regional Haze State...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

... Promulgation of Air Quality Implementation Plans; Pennsylvania; Regional Haze State Implementation Plan...'s limited approval of Pennsylvania's Regional Haze State Implementation Plan (SIP). DATES: Effective... announcing our limited approval of Pennsylvania's Regional Haze SIP. In this document, we inadvertently...

77 FR 60085 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5 emissions inventory...

19 CFR 115.43 - Termination of approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.43 Termination of approval. Approval of a container terminates upon a change in the container by a major repair or alteration of any of the essential...

19 CFR 115.43 - Termination of approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.43 Termination of approval. Approval of a container terminates upon a change in the container by a major repair or alteration of any of the essential...

19 CFR 115.43 - Termination of approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.43 Termination of approval. Approval of a container terminates upon a change in the container by a major repair or alteration of any of the essential...

19 CFR 115.43 - Termination of approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.43 Termination of approval. Approval of a container terminates upon a change in the container by a major repair or alteration of any of the essential...

19 CFR 115.43 - Termination of approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.43 Termination of approval. Approval of a container terminates upon a change in the container by a major repair or alteration of any of the essential...

46 CFR 160.050-7 - Procedure for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular Plastic § 160.050-7 Procedure for approval. (a) General. Designs of ring life buoys are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a ring life buoy design shall follow the...

46 CFR 160.001-3 - Procedure for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-3 Procedure for approval. (a) General. Designs of life preservers are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a life preserver design shall follow the procedures of this section and subpart 159...

46 CFR 160.001-3 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-3 Procedure for approval. (a) General. Designs of life preservers are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a life preserver design shall follow the procedures of this section and subpart 159...

46 CFR 160.001-3 - Procedure for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-3 Procedure for approval. (a) General. Designs of life preservers are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a life preserver design shall follow the procedures of this section and subpart 159...

46 CFR 160.050-7 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular Plastic § 160.050-7 Procedure for approval. (a) General. Designs of ring life buoys are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a ring life buoy design shall follow the...

46 CFR 160.050-7 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular Plastic § 160.050-7 Procedure for approval. (a) General. Designs of ring life buoys are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a ring life buoy design shall follow the...

46 CFR 160.050-7 - Procedure for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular Plastic § 160.050-7 Procedure for approval. (a) General. Designs of ring life buoys are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a ring life buoy design shall follow the...

46 CFR 160.050-7 - Procedure for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular Plastic § 160.050-7 Procedure for approval. (a) General. Designs of ring life buoys are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a ring life buoy design shall follow the...

46 CFR 160.001-3 - Procedure for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-3 Procedure for approval. (a) General. Designs of life preservers are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a life preserver design shall follow the procedures of this section and subpart 159...

46 CFR 160.001-3 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-3 Procedure for approval. (a) General. Designs of life preservers are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a life preserver design shall follow the procedures of this section and subpart 159...

Development of the supply chain oriented quality assurance system for aerospace manufacturing SMEs and its implementation perspectives

NASA Astrophysics Data System (ADS)

Hussein, Abdullahi; Cheng, Kai

2016-10-01

Aerospace manufacturing SMEs are continuously facing the challenge on managing their supply chain and complying with the aerospace manufacturing quality standard requirement due to their lack of resources and the nature of business. In this paper, the ERP system based approach is presented to quality control and assurance work in light of seamless integration of in-process production data and information internally and therefore managing suppliers more effectively and efficiently. The Aerospace Manufacturing Quality Assurance Standard (BS/EN9100) is one of the most recognised and essential protocols for developing the industry-operated-and-driven quality assurance systems. The research investigates using the ERP based system as an enabler to implement BS/EN9100 quality management system at manufacturing SMEs and the associated implementation and application perspectives. An application case study on a manufacturing SME is presented by using the SAP based implementation, which helps further evaluate and validate the approach and application system development.

78 FR 63933 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revised Ambient Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

...] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revised Ambient Air Quality... of Virginia adding ambient air quality standards and associated reference conditions for Fine Particulate Matter (PM 2.5 ) that are consistent with the 2013 National Ambient Air Quality Standards (NAAQS...

77 FR 60087 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... National Ambient Air Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5...

How to Improve Quality If You're Not in Manufacturing.

ERIC Educational Resources Information Center

Johnson, Gary K.; Dumas, Roland A.

1992-01-01

Discusses the problems of applying quality methods to jobs that are not directly involved with manufacturing such as sales, merchandising, law, health care, accounting, and food service. Presents a model for nonmanufacturing organizations. (JOW)

Relational-database model for improving quality assurance and process control in a composite manufacturing environment

NASA Astrophysics Data System (ADS)

Gentry, Jeffery D.

2000-05-01

A relational database is a powerful tool for collecting and analyzing the vast amounts of inner-related data associated with the manufacture of composite materials. A relational database contains many individual database tables that store data that are related in some fashion. Manufacturing process variables as well as quality assurance measurements can be collected and stored in database tables indexed according to lot numbers, part type or individual serial numbers. Relationships between manufacturing process and product quality can then be correlated over a wide range of product types and process variations. This paper presents details on how relational databases are used to collect, store, and analyze process variables and quality assurance data associated with the manufacture of advanced composite materials. Important considerations are covered including how the various types of data are organized and how relationships between the data are defined. Employing relational database techniques to establish correlative relationships between process variables and quality assurance measurements is then explored. Finally, the benefits of database techniques such as data warehousing, data mining and web based client/server architectures are discussed in the context of composite material manufacturing.

46 CFR 160.053-6 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-6 Procedure for approval. (a) General. Work vests for use on merchant vessels are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a work vest shall follow the procedures of this section...

46 CFR 160.053-6 - Procedure for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-6 Procedure for approval. (a) General. Work vests for use on merchant vessels are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a work vest shall follow the procedures of this section...

46 CFR 160.053-6 - Procedure for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-6 Procedure for approval. (a) General. Work vests for use on merchant vessels are approved only by the Commandant, U.S. Coast Guard. Manufacturers seeking approval of a work vest shall follow the procedures of this section...

Process and product development in the manufacturing of molecular therapeutics.

PubMed

Atkinson, E M; Christensen, J R

1999-08-01

In the development of molecular therapies, a great deal of attention has focused on tissue targets, gene delivery vectors, and expression cassettes. In order to become an approved therapy, however, a molecular therapeutic has to pass down the same product registration pathway as any other biological product. Moving from research into industrial production requires careful attention to regulatory, manufacturing and quality concerns. Early work on developing and characterizing robust and scaleable manufacturing processes will ultimately be rewarded by ease of implementation as the product is successful in clinical trials. Regulatory agencies require solid process and product characterization studies to demonstrate control and understanding of the molecular therapeutic. As the gene therapy industry matures, standards will continue to rise, creating an industry that is capable of producing safe, high-quality and effective therapies for many of the world's most difficult disease targets.

30 CFR 22.9 - How approvals are granted.

Code of Federal Regulations, 2011 CFR

2011-07-01

... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

30 CFR 22.9 - How approvals are granted.

Code of Federal Regulations, 2014 CFR

2014-07-01

... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

30 CFR 22.9 - How approvals are granted.

Code of Federal Regulations, 2012 CFR

2012-07-01

... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

30 CFR 22.9 - How approvals are granted.

Code of Federal Regulations, 2013 CFR

2013-07-01

... APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.9 How approvals are granted. All approvals are granted by official letter from MSHA. A detector will be approved under this part only when the testing..., including drawings from the manufacturer that show the detector as it is to be commercially made. No verbal...

Investigating emergency room service quality using lean manufacturing.

PubMed

Abdelhadi, Abdelhakim

2015-01-01

The purpose of this paper is to investigate a lean manufacturing metric called Takt time as a benchmark evaluation measure to evaluate a public hospital's service quality. Lean manufacturing is an established managerial philosophy with a proven track record in industry. A lean metric called Takt time is applied as a measure to compare the relative efficiency between two emergency departments (EDs) belonging to the same public hospital. Outcomes guide managers to improve patient services and increase hospital performances. The patient treatment lead time within the hospital's two EDs (one department serves male and the other female patients) are the study's focus. A lean metric called Takt time is used to find the service's relative efficiency. Findings show that the lean manufacturing metric called Takt time can be used as an effective way to measure service efficiency by analyzing relative efficiency and identifies bottlenecks in different departments providing the same services. The paper presents a new procedure to compare relative efficiency between two EDs. It can be applied to any healthcare facility.

49 CFR 178.74 - Approval of MEGCs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Specifications for Cylinders § 178.74 Approval of MEGCs. (a) Application for design type approval. (1) Each new MEGC design type must have a design approval certificate. An owner or manufacturer must apply to an... materials of the same type and thickness, by the same fabrication techniques and with identical supports...

76 FR 42557 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Regional Haze State...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

... Promulgation of Air Quality Implementation Plans; Delaware; Regional Haze State Implementation Plan AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is approving the Delaware Regional Haze... visibility in mandatory Class I areas through a regional haze program. EPA is also approving this revision...

77 FR 50660 - Limited Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County; Stationary Source... Clark County, Nevada. DATES: Any comments on this proposal must arrive by September 7, 2012. ADDRESSES... regulations submitted for approval into the Clark County portion of the Nevada State Implementation Plan (SIP...

76 FR 8330 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-14

... Promulgation of Air Quality Implementation Plans; Virginia; Revision to the Definition of Volatile Organic... approve the State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia consisting... section of this Federal Register, EPA is approving Virginia's SIP submittal as a direct final rule without...

75 FR 8575 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

... Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the Definition of Volatile Organic... proposes to approve the State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia... (VOC). In the Final Rules section of this Federal Register, EPA is approving Virginia's SIP submittal...

76 FR 63574 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Miscellaneous Metal and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-13

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2010-1001; FRL-9478-5] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Miscellaneous Metal and Plastic Parts Surface... Indiana's miscellaneous metal and plastic parts surface coating rules. These rules are approvable because...

24 CFR 3282.361 - Design Approval Primary Inspection Agency (DAPIA).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Design Approval Primary Inspection... REGULATIONS Primary Inspection Agencies § 3282.361 Design Approval Primary Inspection Agency (DAPIA). (a... manufactured home designs submitted to it by the manufacturer and for assuring that they conform to the...

California Air Quality State Implementation Plans; Final Approval; Butte County Air Quality Management District; Stationary Source Permits

EPA Pesticide Factsheets

EPA is taking final action to approve a revision to the Butte County Air Quality Management District (BCAQMD) portion of the California State Implementation Plan (SIP). This revision concerns the District's New Source Review (NSR) permitting program.

10 CFR 52.175 - Transfer of manufacturing license.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Transfer of manufacturing license. 52.175 Section 52.175 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Manufacturing Licenses § 52.175 Transfer of manufacturing license. A manufacturing license...

7 CFR 3550.73 - Manufactured homes.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURE DIRECT SINGLE FAMILY HOUSING LOANS AND GRANTS Section 502 Origination § 3550.73 Manufactured homes... 502 loans on manufactured homes are subject to the same conditions as all other section 502 loans. (a... loans will be made on a manufactured home sold by any entity that is not an approved dealer-contractor...

78 FR 5346 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts and New Hampshire...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

...-FRL-9754-7] Approval and Promulgation of Air Quality Implementation Plans; Massachusetts and New... (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve State Implementation Plan (SIP... repair network for an on-board diagnostic (OBD2) testing program for model year 1996 and newer vehicles...

78 FR 34915 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2013-0289; FRL-9822-3] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to the Classification and Implementation... approving these revisions to include the classification of Northern Virginia as ``marginal'' for the 2008...

75 FR 81555 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Sulfur Dioxide SIP...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2009-0808; FRL-9243-4] Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Sulfur Dioxide SIP Revision for Marathon Petroleum... proposing to approve a sulfur dioxide State Implementation Plan revision request for Marathon Petroleum in...

77 FR 59879 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; PBR and PTIO

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

... its air pollution permit program more efficient. Approving these additions will make the Permits by... revisions will make Ohio's air permit program more efficient while continuing to protect human health and...-9714-6] Approval and Promulgation of Air Quality Implementation Plans; Ohio; PBR and PTIO AGENCY...

Notification: Evaluation of EPA’s Approval Process for Air Quality Dispersion Models

EPA Pesticide Factsheets

Project #OPE-FY17-0016, June 5, 2017. The EPA OIG plans to begin preliminary research to assess the effectiveness of EPA's process for reviewing and approving air quality dispersion models it recommends for use.

78 FR 6035 - Approval and Promulgation of Air Quality Implementation Plans; Ohio and Indiana; Cincinnati...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-29

... MOBILE6.2 emissions model. The ozone maintenance plan established 2015 and 2020 budgets for the Ohio and...-9773-5] Approval and Promulgation of Air Quality Implementation Plans; Ohio and Indiana; Cincinnati-Hamilton, OH; Ohio and Indiana 1997 8-Hour Ozone Maintenance Plan Revisions to Approved Motor Vehicle...

78 FR 19164 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2012-0088; FRL-9783-4] Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards AGENCY: Environmental... submitted a request to approve a section of its particulate matter (PM) rules on February 23, 2012. The PM...

76 FR 14602 - Approval and Promulgation of Air Quality Implementation Plans; Louisiana; Revisions To Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

... Promulgation of Air Quality Implementation Plans; Louisiana; Revisions To Control Volatile Organic Compound...: Proposed rule. SUMMARY: EPA is proposing to approve State Implementation Plan (SIP) revisions for control... submitted to EPA on August 31, 2010. EPA is also proposing to approve a SIP revision for control of emission...

78 FR 18241 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Flint Hills Resources...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2011-0328; FRL-9792-8] Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Flint Hills Resources Pine Bend AGENCY... rule approving a revision to the the Minnesota sulfur dioxide SIP for Flint Hills Resources Pine Bend...

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.

PubMed

Davis, Courtney; Naci, Huseyin; Gurpinar, Evrim; Poplavska, Elita; Pinto, Ashlyn; Aggarwal, Ajay

2017-10-04

Objective  To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design  Retrospective cohort study. Setting  Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures  Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results  From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years' follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions

Improvements in Operational Readiness by Distributing Manufacturing Capability in the Supply Chain through Additive Manufacturing

DTIC Science & Technology

2017-12-01

inefficiencies of a more complex system. Additional time may also be due to the longer distances traveled . The fulfillment time for a requisition to...Approved OMB No. 0704-0188 Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time ...advanced manufacturing methods with additive manufacturing. This work decomposes the additive manufacturing processes into 11 primary functions. The time

78 FR 28143 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Sulfur Dioxide and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-14

...-9811-6] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Sulfur Dioxide and Nitrogen Dioxide Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA). ACTION... amend the national ambient air quality standards (NAAQS) for NO 2 and SO 2 to be consistent with the...

77 FR 59156 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; The Washington County...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... Promulgation of Air Quality Implementation Plans; Maryland; The Washington County 2002 Base Year Inventory... approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the State of... proposing to approve the 2002 base year PM 2.5 emissions inventory for Washington County submitted by MDE in...

78 FR 28503 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter Counties...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-15

...: FRL-9812-4] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter Counties, Indiana, 1997 8-Hour Ozone Maintenance Plan and 1997 Annual Fine Particulate Matter Maintenance Plan Revision to Approved Motor Vehicle Emissions Budgets AGENCY: Environmental Protection Agency (EPA...

78 FR 28550 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter Counties...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-15

...-9812-3] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Lake and Porter Counties, Indiana, 1997 8-Hour Ozone Maintenance Plan and 1997 Annual Fine Particulate Matter Maintenance Plan Revisions to Approved Motor Vehicle Emissions Budgets AGENCY: Environmental Protection Agency (EPA...

76 FR 76403 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-07

... Activities; Submission to OMB for Review and Approval; Comment Request; Pre-Manufacture Review Reporting and... review and approval: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical....regulations.gov . Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical...

Quality of frozen fruit bars manufactured through infrared pre-dehydration

USDA-ARS?s Scientific Manuscript database

In this study, frozen restructured whole apple and strawberry bars were manufactured by partial dehydration, using infrared (IR) heating, followed by restructuring and freezing. The objective of this investigation was to determine the effect of IR partial dehydration on the quality of restructured f...

78 FR 78263 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

...] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor Vehicle... Implementation Plan (SIP). The revisions consist of an update to the SIP-approved Motor Vehicle Emissions Budgets... operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct...

75 FR 78952 - Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-17

... Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; Commonwealth of Virginia... Declaration and Withdrawal of EPA Plan Approval AGENCY: Environmental Protection Agency (EPA). ACTION... request for EPA withdrawal of its section 111(d)/129 plan (the plan) approval for HMIWI units. Submittal...

Sterile products: advances and challenges in formulation, manufacturing and regulatory aspects--a regulatory review perspective.

PubMed

Hussong, David

2010-09-01

For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. An overview of the product quality microbiology aspects for sterile drugs is provided.

A manufacturing quality assessment model based-on two stages interval type-2 fuzzy logic

NASA Astrophysics Data System (ADS)

Purnomo, Muhammad Ridwan Andi; Helmi Shintya Dewi, Intan

2016-01-01

This paper presents the development of an assessment models for manufacturing quality using Interval Type-2 Fuzzy Logic (IT2-FL). The proposed model is developed based on one of building block in sustainable supply chain management (SSCM), which is benefit of SCM, and focuses more on quality. The proposed model can be used to predict the quality level of production chain in a company. The quality of production will affect to the quality of product. Practically, quality of production is unique for every type of production system. Hence, experts opinion will play major role in developing the assessment model. The model will become more complicated when the data contains ambiguity and uncertainty. In this study, IT2-FL is used to model the ambiguity and uncertainty. A case study taken from a company in Yogyakarta shows that the proposed manufacturing quality assessment model can work well in determining the quality level of production.

19 CFR 115.10 - Certificate of approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS... design type for a specified number or unlimited series of containers that are approved in accordance with..., 1975. (b) Containers—(1) Approval after manufacture. A Certifying Authority shall issue a certificate...

19 CFR 115.10 - Certificate of approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS... design type for a specified number or unlimited series of containers that are approved in accordance with..., 1975. (b) Containers—(1) Approval after manufacture. A Certifying Authority shall issue a certificate...

19 CFR 115.10 - Certificate of approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS... design type for a specified number or unlimited series of containers that are approved in accordance with..., 1975. (b) Containers—(1) Approval after manufacture. A Certifying Authority shall issue a certificate...

19 CFR 115.10 - Certificate of approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS... design type for a specified number or unlimited series of containers that are approved in accordance with..., 1975. (b) Containers—(1) Approval after manufacture. A Certifying Authority shall issue a certificate...

19 CFR 115.10 - Certificate of approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS... design type for a specified number or unlimited series of containers that are approved in accordance with..., 1975. (b) Containers—(1) Approval after manufacture. A Certifying Authority shall issue a certificate...

Manufacture and Quality Control of Insert Coil with Real ITER TF Conductor

DOE PAGES

Ozeki, H.; Isono, T.; Uno, Y.; ...

2016-03-02

JAEA successfully completed the manufacture of the toroidal field (TF) insert coil (TFIC) for a performance test of the ITER TF conductor in the final design in cooperation with Hitachi, Ltd. The TFIC is a single-layer 8.875-turn solenoid coil with 1.44-m diameter. This will be tested for 68-kA current application in a 13-T external magnetic field. TFIC was manufactured in the following order: winding of the TF conductor, lead bending, fabrication of the electrical termination, heat treatment, turn insulation, installation of the coil into the support mandrel structure, vacuum pressure impregnation (VPI), structure assembly, and instrumentation. Here in this presentation,more » manufacture process and quality control status for the TFIC manufacturing are reported.« less

78 FR 70516 - Approval and Promulgation of Air Quality Implementation Plans; Illinois

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-26

...] Approval and Promulgation of Air Quality Implementation Plans; Illinois AGENCY: Environmental Protection... Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. Hand Delivery: Pamela Blakley, Chief, Control Strategies Section, Air Programs...

78 FR 63148 - Approval and Promulgation of Air Quality Implementation Plans; Indiana

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

...] Approval and Promulgation of Air Quality Implementation Plans; Indiana AGENCY: Environmental Protection... Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. Hand Delivery: Pamela Blakley, Chief, Control Strategies Section, Air Programs...

New approach for quality control in manufacturing process

NASA Astrophysics Data System (ADS)

Hanzah, Muhammad Radhi bin; Rahim, Wan Mohd Faizal Wan Abd; Khor, C. Y.; Ishak, Muhammad Ikman; Rosli, M. U.; Jamalludin, Mohd Riduan; Zakaria, M. S.; Nawi, M. A. M.

2017-09-01

This study was regulated exclusively in view of theoretical aspect and further research should be done to demonstrate it in the genuine circumstance. The structure of this investigation including two industrial visits, i.e. interviews and meeting with approved staff from each organization agents. This review is cut up into two sections. Aside from the perception, little gatherings with the staffs from both organizations are held. With the subtle elements, the review is begun up. The aim of the study is characterized as to enhance the assessment strategy at quality control station to minimize defect outflow to the following client. This is to investigate the underlying factor in ebb and flow quality control framework so that another strategy to enhance quality control framework can implemented. Quality is a basic characteristic to be instated so that the end goal to fulfill clients' need is achieved. After a long hypothetical review is made, the best answer for be actualized at QG station to beat defects outflow to the following customer is by photoelectric sensor. It is reasonable, simple to keep up and has a high affectability to identify the defective items at the QG station.

76 FR 69927 - Approval of Air Quality Implementation Plans; California; South Coast; Attainment Plan for 1997...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-09

...EPA is approving in part and disapproving in part state implementation plan (SIP) revisions submitted by California to provide for attainment of the 1997 fine particulate matter (PM2.5) national ambient air quality standards in the Los Angeles-South Coast area (South Coast). These SIP revisions are the South Coast 2007 Air Quality Management Plan (South Coast 2007 AQMP) (revised 2011) and South Coast-related provisions of the 2007 State Strategy (revised 2009 and 2011). EPA is approving the emissions inventory; reasonably available control measures/reasonably available control technology demonstration; the reasonable further progress and attainment demonstrations and associated air quality modeling; and the transportation conformity motor vehicle emissions budgets. EPA is also granting California's request to extend the attainment deadline for the South Coast to April 5, 2015 and approving commitments to measures and reductions by the South Coast Air Quality Management District and the California Air Resources Board. Finally, we are disapproving the SIP's contingency measures and issuing a protective finding under 40 CFR 93.120(a)(3), and we are rejecting the assignment of 10 tons per day (tpd) of nitrogen oxide (NOX) reductions to the federal government.

77 FR 65625 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Determination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality... Portsmouth-Dover-Rochester and Manchester Areas AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: The EPA is making four separate and independent air quality determinations for two areas...

76 FR 27973 - Approval and Promulgation of Air Quality Implementation Plans; Indiana

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2010-0999; FRL-9304-9] Approval and Promulgation of Air Quality Implementation Plans; Indiana AGENCY: Environmental Protection Agency (EPA). ACTION..., Control Strategies Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, Region 5...

77 FR 41954 - Approval and Promulgation of Air Quality Implementation Plans; Indiana

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-17

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2012-0406; FRL-9699-2] Approval and Promulgation of Air Quality Implementation Plans; Indiana AGENCY: Environmental Protection Agency (EPA). ACTION..., Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard...

27 CFR 20.192 - Manufacturing record.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Manufacturing record. 20.192 Section 20.192 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU... product manufactured, as applicable. (Approved by the Office of Management and Budget under control number...

78 FR 900 - Approval and Promulgation of Air Quality Implementation Plans; Alaska: Eagle River PM10

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-07

...-7] Approval and Promulgation of Air Quality Implementation Plans; Alaska: Eagle River PM 10... National Ambient Air Quality Standards (NAAQS) for particulate matter with an aerodynamic diameter less... under section 110 and part D of the CAA? D. Has the State demonstrated that the air quality improvement...

Quality Improvement, Inventory Management, Lead Time Reduction and Production Scheduling in High-Mix Manufacturing Environments

DTIC Science & Technology

2017-01-13

Quality Improvement, Inventory Management, Lead Time Reduction and Production Scheduling in High-mix Manufacturing Environments by Sean Daigle B.S...for the degree of Master of Engineering in Advanced Manufacturing and Design at the MASSACHUSETTS INSTITUTE OF TECHNOLOGY February 2017 c... Production Scheduling in High-mix Manufacturing Environments by Sean Daigle Submitted to the Department of Mechanical Engineering on January 13, 2017, in

Integration of Machining and Inspection in Aerospace Manufacturing

NASA Astrophysics Data System (ADS)

Simpson, Bart; Dicken, Peter J.

2011-12-01

The main challenge for aerospace manufacturers today is to develop the ability to produce high-quality products on a consistent basis as quickly as possible and at the lowest-possible cost. At the same time, rising material prices are making the cost of scrap higher than ever so making it more important to minimise waste. Proper inspection and quality control methods are no longer a luxury; they are an essential part of every manufacturing operation that wants to grow and be successful. However, simply bolting on some quality control procedures to the existing manufacturing processes is not enough. Inspection must be fully-integrated with manufacturing for the investment to really produce significant improvements. The traditional relationship between manufacturing and inspection is that machining is completed first on the company's machine tools and the components are then transferred to dedicated inspection equipment to be approved or rejected. However, as machining techniques become more sophisticated, and as components become larger and more complex, there are a growing number of cases where closer integration is required to give the highest productivity and the biggest reductions in wastage. Instead of a simple linear progression from CAD to CAM to machining to inspection, a more complicated series of steps is needed, with extra data needed to fill any gaps in the information available at the various stages. These new processes can be grouped under the heading of "adaptive machining". The programming of most machining operations is based around knowing three things: the position of the workpiece on the machine, the starting shape of the material to be machined, and the final shape that needs to be achieved at the end of the operation. Adaptive machining techniques allow successful machining when at least one of those elements is unknown, by using in-process measurement to close the information gaps in the process chain. It also allows any errors to be spotted

78 FR 28173 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Sulfur Dioxide and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-14

...-9811-5] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Sulfur Dioxide and Nitrogen Dioxide Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA). ACTION... implementation plan (SIP) for nitrogen dioxide (NO 2 ) and sulfur dioxide (SO 2 ) under the Clean Air Act. This...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

19 CFR 115.28 - Application for approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers by Design Type § 115.28 Application for approval. Each application by a... inspection; and (e) A statement signed by the manufacturer that: (1) A container of the design type concerned...

24 CFR 3285.2 - Manufacturer installation instructions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HOUSING AND URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS General § 3285.2 Manufacturer... approved installation instructions must include all topics covered in the Model Installation Standards for... installation instructions meet or exceed the Model Installation Standards for foundation support and anchoring...

24 CFR 3285.2 - Manufacturer installation instructions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HOUSING AND URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS General § 3285.2 Manufacturer... approved installation instructions must include all topics covered in the Model Installation Standards for... installation instructions meet or exceed the Model Installation Standards for foundation support and anchoring...

24 CFR 3285.2 - Manufacturer installation instructions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HOUSING AND URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS General § 3285.2 Manufacturer... approved installation instructions must include all topics covered in the Model Installation Standards for... installation instructions meet or exceed the Model Installation Standards for foundation support and anchoring...

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

PubMed

Ishii-Watabe, Akiko; Hirose, Akihiko; Katori, Noriko; Hashii, Norikata; Arai, Susumu; Awatsu, Hirotoshi; Eiza, Akira; Hara, Yoshiaki; Hattori, Hideshi; Inoue, Tomomi; Isono, Tetsuya; Iwakura, Masahiro; Kajihara, Daisuke; Kasahara, Nobuo; Matsuda, Hiroyuki; Murakami, Sei; Nakagawa, Taishiro; Okumura, Takehiro; Omasa, Takeshi; Takuma, Shinya; Terashima, Iyo; Tsukahara, Masayoshi; Tsutsui, Maiko; Yano, Takahiro; Kawasaki, Nana

2015-10-01

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

78 FR 34972 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2013-0289; FRL-9822-2] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to the Classification and Implementation of the 2008 Ozone National Ambient Air Quality Standards for the Northern Virginia Nonattainment Area...

15 CFR 400.33 - Restrictions on manufacturing and processing activity.

Code of Federal Regulations, 2010 CFR

2010-01-01

...-TRADE ZONES BOARD Manufacturing and Processing Activity-Reviews § 400.33 Restrictions on manufacturing and processing activity. (a) In general. In approving manufacturing or processing activity for a zone... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Restrictions on manufacturing and...

76 FR 59344 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Transportation...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-26

... Promulgation of Air Quality Implementation Plans; Maryland; Transportation Conformity Regulations AGENCY... Implementation Plan (SIP) revision submitted by Maryland to establish transportation conformity regulations. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a...

78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

... documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

Study of twenty preparations of human albumin solution which failed in quality control testing due to elevated sodium content, a poor internal quality control at manufacturing unit.

PubMed

Prasad, J P; Madhu, Y; Singh, Surinder; Soni, G R; Agnihotri, N; Singh, Varsha; Kumar, Pradeep; Jain, Nidhi; Prakash, Anu; Singh, Varun

2016-11-01

Current study is conducted in our laboratory due to failure in quality control testing of twenty batches of Human Albumin solution in which sodium content is higher than the prescribed limit. These batches are received in short duration from indigenous manufacturer and is the first incident of failure of Human albumin preparation in sodium content of manufacturer. On request of manufacturer, study is conducted to rule out the cause. Repeat testing of each out of specification batch is conducted and a trend analysis is drawn between our findings and manufacturer's results, also study of trend analysis of manufacturer for the last one year. Trend analysis data indicated towards poor consistency of batches with major shift at various time intervals in sodium content of human albumin preparation. Further analysis rule out that non-traceable quality of standard used in the internal quality control testing by manufacturer is the root cause of the problem. Copyright © 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

78 FR 4337 - Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Infrastructure and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

... Promulgation of Air Quality Implementation Plans; New Mexico; Infrastructure and Interstate Transport.... SUMMARY: EPA is approving the submittal from the State of New Mexico pursuant to the Clean Air Act (CAA or..., and enforce the 2006 fine particulate matter (PM 2.5 ) national ambient air quality standards (NAAQS...

46 CFR 162.017-6 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... screens. (c) Pre-approval tests. Before approval is granted, the manufacturer shall have tests conducted, or submit evidence that such tests have been conducted, by the Underwriters' Laboratories, the... design or type of pressure-vacuum relief valve shall submit drawings in quadruplicate showing the design...

46 CFR 162.017-6 - Procedure for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... screens. (c) Pre-approval tests. Before approval is granted, the manufacturer shall have tests conducted, or submit evidence that such tests have been conducted, by the Underwriters' Laboratories, the... design or type of pressure-vacuum relief valve shall submit drawings in quadruplicate showing the design...

78 FR 73445 - Disapproval, Approval and Promulgation of Air Quality Implementation Plan Revisions...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

...] Disapproval, Approval and Promulgation of Air Quality Implementation Plan Revisions; Infrastructure... State of Wyoming to demonstrate that the SIP meets the infrastructure requirements of the Clean Air Act... revised NAAQS is promulgated, review their SIPs to ensure that they meet infrastructure requirements. The...

75 FR 34669 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Transportation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-18

... Promulgation of Air Quality Implementation Plans; Maryland; Transportation Conformity Regulations AGENCY... Implementation Plan (SIP) revision submitted by Maryland for Transportation Conformity Regulations. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final...

75 FR 5514 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2009-0771; FRL-9108-7] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Correction AGENCY: Environmental Protection Agency..., Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection...

75 FR 39635 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-12

..., quality-assured and certified ambient air quality monitoring data for the 2006-2008 ozone seasons that... data for the 2009 ozone season have been recorded in the EPA's Air Quality System (AQS) and show that... NAAQS through 2020 in the areas. EPA is approving the 2005 base year emissions inventories for the...

Data quality and processing for decision making: divergence between corporate strategy and manufacturing processes

NASA Astrophysics Data System (ADS)

McNeil, Ronald D.; Miele, Renato; Shaul, Dennis

2000-10-01

Information technology is driving improvements in manufacturing systems. Results are higher productivity and quality. However, corporate strategy is driven by a number of factors and includes data and pressure from multiple stakeholders, which includes employees, managers, executives, stockholders, boards, suppliers and customers. It is also driven by information about competitors and emerging technology. Much information is based on processing of data and the resulting biases of the processors. Thus, stakeholders can base inputs on faulty perceptions, which are not reality based. Prior to processing, data used may be inaccurate. Sources of data and information may include demographic reports, statistical analyses, intelligence reports (e.g., marketing data), technology and primary data collection. The reliability and validity of data as well as the management of sources and information is critical element to strategy formulation. The paper explores data collection, processing and analyses from secondary and primary sources, information generation and report presentation for strategy formulation and contrast this with data and information utilized to drive internal process such as manufacturing. The hypothesis is that internal process, such as manufacturing, are subordinate to corporate strategies. The impact of possible divergence in quality of decisions at the corporate level on IT driven, quality-manufacturing processes based on measurable outcomes is significant. Recommendations for IT improvements at the corporate strategy level are given.

76 FR 80332 - Foreign-Trade Zone 7-Mayaguez, PR, Expansion of Manufacturing Authority; Amgen Manufacturing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-23

... approved by the Board in 2008 for the manufacture of epogen[reg] (epoetin alfa), neupogen[reg] (filgrastim), aransep[reg] (darbepoetin alfa), enbrel[reg] (etanercept), kineret[reg] (anakinra), and neulasta[reg...

Case study of lean manufacturing application in a die casting manufacturing company

NASA Astrophysics Data System (ADS)

Ching, Ng Tan; Hoe, Clarence Chan Kok; Hong, Tang Sai; Ghobakhloo, Morteza; Pin, Chen Kah

2015-05-01

The case study of lean manufacturing aims to study the application of lean manufacturing in a die casting manufacturing company located in Pulau Penang, Malaysia. This case study describes mainly about the important concepts and applications of lean manufacturing which could gradually help the company in increasing the profit by studying and analyzing their current manufacturing process and company culture. Many approaches of lean manufacturing are studied in this project which includes: 5S housekeeping, Kaizen, and Takt Time. Besides, the lean tools mentioned, quality tool such as the House of Quality is being used as an analysis tool to continuously improve the product quality. In short, the existing lean culture in the company is studied and analyzed, with recommendations written at the end of this paper.

Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals: A Systematic Review.

PubMed

Woersching, Alex L; Borrego, Matthew E; Raisch, Dennis W

2016-12-01

To systematically review and assess the quality of the novel drugs' economic evaluation literature in print during the drugs' early commercial availability following US regulatory approval. MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009. The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses). We extracted and analyzed data from 36 articles considering 19 of the 50 drugs. Two reviewers assessed each publication's quality using the Quality of Health Economic Studies (QHES) instrument and summarized study quality on a 100-point scale. Study quality had a mean of 70.0 ± 16.2 QHES points. The only study characteristics associated with QHES score (with P < 0.05) were having used modeling or advanced statistics, 75.1 versus 61.9 without; using quality-adjusted life years as an outcome, 75.9 versus 64.7 without; and cost-utility versus cost-minimization analysis, 75.9 versus 58.7. Studies most often satisfied quality aspects about stating study design choices and least often satisfied aspects about justifying design choices. The reviewed literature considered a minority of the 2008-2009 novel drugs and had mixed study quality. Cost-effectiveness stakeholders might benefit from efforts to improve the quality and quantity of literature examining novel drugs. Editors and reviewers may support quality improvement by stringently imposing economic evaluation guidelines about justifying study design choices. © The Author(s) 2016.

Simulation of textile manufacturing processes for planning, scheduling, and quality control purposes

NASA Astrophysics Data System (ADS)

Cropper, A. E.; Wang, Z.

1995-08-01

Simulation, as a management information tool, has been applied to engineering manufacture and assembly operations. The application of the principles to textile manufacturing (fiber to fabric) is discussed. The particular problems and solutions in applying the simulation software package to the yarn production processes are discussed with an indication of how the software achieves the production schedule. The system appears to have application in planning, scheduling, and quality assurance. The latter being a result of the traceability possibilities through a process involving mixing and splitting of material.

78 FR 71554 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Transportation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

...] Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Transportation Conformity and... of New Hampshire. This revision establishes transportation conformity criteria and procedures related...-R01-OAR-2012-0113,'' Anne Arnold, U.S. [[Page 71555

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

PubMed

Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data

[Special aspects of quality of Tibetan medicines--insights from over 40 years of manufacturing experience in Switzerland].

PubMed

Schwabl, Alexandra; Gämperle, Erich

2013-01-01

Tibetan recipes are complex formulas from plant and mineral ingredients. Padma Inc. has been producing selected formulas from Tibetan Medicine in Switzerland since more than 40 years. Modern quality standards and Good Manufacturing Practice (GMP) guidelines are followed, ensuring the quality of the raw materials through the manufacturing processes to the finished product. The aim is to provide these valuable formulas to people in the West in a consistently high quality 'made in Switzerland'. The production according to modern quality standards is challenging, draws on many resources, and requires specialized expertise, e.g. in the procurement of raw materials and the quality analysis including pharmacognostic and botanical knowledge.

77 FR 60094 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5 emissions inventory for the...

77 FR 17409 - Foreign-Trade Zone 45-Portland, OR Expansion of Manufacturing Authority Epson Portland, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

..., OR Expansion of Manufacturing Authority Epson Portland, Inc. (Inkjet Ink); Notice of Approval of... (19 CFR 146.41) inputs in manufacturing of ink for inkjet printer cartridges. Notice was given in the... approved authority to include the use of certain PF status inputs in the manufacturing of ink for inkjet...

75 FR 48894 - Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Revisions to Emissions...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-12

... Promulgation of Air Quality Implementation Plans; New Mexico; Revisions to Emissions Inventory Reporting.... SUMMARY: The EPA is proposing to approve revisions to the New Mexico State Implementation Plan (SIP... Quality Standards that EPA has established for criteria pollutants such as ozone, particulate matter, and...

77 FR 2937 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Nonattainment New...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-20

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2011-0925; FRL- 9619-6] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Nonattainment New Source Review Rules AGENCY: Environmental Protection Agency (EPA). [[Page 2938

78 FR 63437 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... the 2010 Sulfur Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection Agency... requirements for the 2010 sulfur dioxide (SO 2 ) NAAQS. This action proposes to approve portions of this... and unless it is reversed or otherwise modified by the Supreme Court, states are not required to...

77 FR 21908 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Streamlining...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

... permit or a Title V permit, ``* * * to permit the evaluation of the air contamination aspects of the... Promulgation of Air Quality Implementation Plans; Pennsylvania; Streamlining Amendments to the Plan Approval... Air Act (CAA). DATES: Written comments must be received on or before May 14, 2012. ADDRESSES: Submit...

75 FR 14077 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; NOX

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2009-0964; FRL-9129-9] Approval and Promulgation of Air Quality Implementation Plans; Illinois; NO X Budget Trading Program; Correction AGENCY... Scientist, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region...

31 CFR 92.1 - Manufacture of medals.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Manufacture of medals. 92.1 Section 92.1 Money and Finance: Treasury Regulations Relating to Money and Finance UNITED STATES MINT OPERATIONS AND PROCEDURES Numismatic Operations § 92.1 Manufacture of medals. With the approval of the...

77 FR 22550 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2012-0073; FRL-9651-6] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container Exemption From VOC Coating Rules... Administrative Code by adding [[Page 22551

Process quality engineering for bioreactor-driven manufacturing of tissue-engineered constructs for bone regeneration.

PubMed

Papantoniou Ir, Ioannis; Chai, Yoke Chin; Luyten, Frank P; Schrooten Ir, Jan

2013-08-01

The incorporation of Quality-by-Design (QbD) principles in tissue-engineering bioprocess development toward clinical use will ensure that manufactured constructs possess prerequisite quality characteristics addressing emerging regulatory requirements and ensuring the functional in vivo behavior. In this work, the QbD principles were applied on a manufacturing process step for the in vitro production of osteogenic three-dimensional (3D) hybrid scaffolds that involves cell matrix deposition on a 3D titanium (Ti) alloy scaffold. An osteogenic cell source (human periosteum-derived cells) cultured in a bioinstructive medium was used to functionalize regular Ti scaffolds in a perfusion bioreactor, resulting in an osteogenic hybrid carrier. A two-level three-factor fractional factorial design of experiments was employed to explore a range of production-relevant process conditions by simultaneously changing value levels of the following parameters: flow rate (0.5-2 mL/min), cell culture duration (7-21 days), and cell-seeding density (1.5×10(3)-3×10(3) cells/cm(2)). This approach allowed to evaluate the individual impact of the aforementioned process parameters upon key quality attributes of the produced hybrids, such as collagen production, mineralization level, and cell number. The use of a fractional factorial design approach helped create a design space in which hybrid scaffolds of predefined quality attributes may be robustly manufactured while minimizing the number of required experiments.

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

PubMed

Fisher, Adam C; Lee, Sau L; Harris, Daniel P; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet

2016-12-30

Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public. Published by Elsevier B.V.

76 FR 58120 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-20

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2010-0770; FRL-9466-5] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Requirements for Preconstruction Review, Prevention of Significant Deterioration AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule...

77 FR 46960 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Forest County...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... Promulgation of Air Quality Implementation Plans; Wisconsin; Forest County Potawatomi Community Reservation... approving procedures for permitting certain sources in relation to the Forest County Potawatomi Community...)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon...

77 FR 42686 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; the 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... Promulgation of Air Quality Implementation Plans; Maryland; the 2002 Base Year Inventory AGENCY: Environmental... matter (PM 2.5 ) 2002 base year emissions inventory portion of the Maryland State Implementation Plan... National Ambient Air Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5...

46 CFR 160.054-7 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Kits, First-Aid, for Inflatable Liferafts § 160.054-7 Procedure... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall furnish... § 160.054-5 to determine the suitability of the first-aid kit for use in conjunction with lifesaving...

46 CFR 160.054-7 - Procedure for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Kits, First-Aid, for Inflatable Liferafts § 160.054-7 Procedure... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall furnish... § 160.054-5 to determine the suitability of the first-aid kit for use in conjunction with lifesaving...

46 CFR 160.054-7 - Procedure for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Kits, First-Aid, for Inflatable Liferafts § 160.054-7 Procedure... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall furnish... § 160.054-5 to determine the suitability of the first-aid kit for use in conjunction with lifesaving...

46 CFR 160.054-7 - Procedure for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Kits, First-Aid, for Inflatable Liferafts § 160.054-7 Procedure... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall furnish... § 160.054-5 to determine the suitability of the first-aid kit for use in conjunction with lifesaving...

California; Northern Sierra Air Quality Management District; Approval of Air Plan Revisions; Wood Burning Devices

EPA Pesticide Factsheets

EPA is taking final action to approve a revision to the Northern Sierra Air Quality Management District (NSAQMD) portion of the California SIP concerning emissions of particulate matter (PM) from wood burning devices.

76 FR 32321 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

...-day window allowed under the prior approved SIP. This SIP revision affects forty-two counties in... inspection stations in the forty-two non-I/M counties. The quality assurance program established a window...

46 CFR 160.076-17 - Approval of design or material changes.

Code of Federal Regulations, 2010 CFR

2010-10-01

... approval before changing PFD production methods. (b) Determinations of equivalence of design, construction... 46 Shipping 6 2010-10-01 2010-10-01 false Approval of design or material changes. 160.076-17... Flotation Devices § 160.076-17 Approval of design or material changes. (a) The manufacturer must submit any...

77 FR 50595 - Approval and Promulgation of Air Quality Implementation Plans; Connecticut, Massachusetts, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

...-RO1-OAR-2008-0445; FRL-9672-5] Approval and Promulgation of Air Quality Implementation Plans; Connecticut, Massachusetts, and Rhode Island; Reasonable Further Progress Plans and 2002 Base Year Emission... revisions establish 2002 base year emission inventories and reasonable further progress emission reduction...

77 FR 66543 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2012-0381; FRL-9747-9] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Requirements for Prevention of Significant...: Environmental Protection Agency (EPA). ACTION: Final rule; correcting amendment. SUMMARY: This document corrects...

75 FR 59179 - Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2010-0657; FRL-9205-7] Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD Regulations AGENCY: Environmental Protection... requirements of the prevention of significant deterioration (PSD) construction permit program in Michigan...

75 FR 14401 - Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2007-1043; FRL-9129-6] Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD Regulations AGENCY: Environmental Protection... (CAA). The revisions consist of requirements of the prevention of significant deterioration (PSD...

77 FR 235 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Procedural Rules...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-04

... Promulgation of Air Quality Implementation Plans; Colorado; Procedural Rules; Conflicts of Interest AGENCY... its members of potential conflicts of interest. We are also reproposing approval of a portion of... federally mandate that Commission members disclose any potential conflicts of interest that arise during...

77 FR 21451 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Procedural Rules...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-10

... Promulgation of Air Quality Implementation Plans; Colorado; Procedural Rules; Conflicts of Interest AGENCY... potential conflicts of interest. We are also approving the remaining portion of Colorado's January 7, 2008... of potential conflicts of interest. (i) Incorporation by reference. (A) Department of Public Health...

75 FR 20942 - Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Transportation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

... Promulgation of Air Quality Implementation Plans; New Mexico; Transportation Conformity Requirement for... proposing to approve a revision to the New Mexico State Implementation Plan (SIP) at New Mexico Administrative Code 20.11.3, concerning transportation conformity rules for Bernalillo County, New Mexico. The...

Social aspects in additive manufacturing of pharmaceutical products.

PubMed

Lind, Johanna; Kälvemark Sporrong, Sofia; Kaae, Susanne; Rantanen, Jukka; Genina, Natalja

2017-08-01

Additive manufacturing (AM) techniques, such as drug printing, represent a new engineering approach that can implement the concept of personalized medicine via on-demand manufacturing of dosage forms with individually adjusted doses. Implementation of AM principles, such as pharmacoprinting, will challenge the entire drug distribution chain and affect the society at different levels. Areas covered: This work summarizes the concept of personalized medicine and gives an overview of possibilities for monitoring patients' health. The most recent activities in the field of printing technologies for fabrication of dosage forms and 'polypills' with flexible doses and tailored release profiles are reviewed. Different scenarios for the drug distribution chain with the required adjustments in drug logistics, quality systems and environmental safety are discussed, as well as whether AM will be used for production of on-demand medicine. The impact of such changes in the distribution chain on regulation, healthcare professionals and patients are highlighted. Expert opinion: Drug manufacturing by traditional methods is well-established, but it lacks the possibility for on-demand personalized drug production. With the recent approval of the first printed medicine, society should be prepared for the changes that will follow the introduction of printed pharmaceuticals.

Product manufacturing, quality, and reliability initiatives to maintain a competitive advantage and meet customer expectations in the semiconductor industry

NASA Astrophysics Data System (ADS)

Capps, Gregory

Semiconductor products are manufactured and consumed across the world. The semiconductor industry is constantly striving to manufacture products with greater performance, improved efficiency, less energy consumption, smaller feature sizes, thinner gate oxides, and faster speeds. Customers have pushed towards zero defects and require a more reliable, higher quality product than ever before. Manufacturers are required to improve yields, reduce operating costs, and increase revenue to maintain a competitive advantage. Opportunities exist for integrated circuit (IC) customers and manufacturers to work together and independently to reduce costs, eliminate waste, reduce defects, reduce warranty returns, and improve quality. This project focuses on electrical over-stress (EOS) and re-test okay (RTOK), two top failure return mechanisms, which both make great defect reduction opportunities in customer-manufacturer relationship. Proactive continuous improvement initiatives and methodologies are addressed with emphasis on product life cycle, manufacturing processes, test, statistical process control (SPC), industry best practices, customer education, and customer-manufacturer interaction.

77 FR 58953 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Control Technique...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... Promulgation of Air Quality Implementation Plans; Delaware; Control Technique Guidelines for Plastic Parts... categories: Plastic Parts, Metal Furniture, Large Appliances, and Miscellaneous Metal Parts. EPA is approving... Compounds, sections 2.0 ``Definitions,'' 12.0 ``Surface Coating of Plastic Parts,'' 19.0 ``Coating of Metal...

77 FR 66945 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-08

... and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably Available Control... Implementation Plan (SIP) revision submitted by the State of New Hampshire. The revision establishes Reasonably... intended effect of this action is to approve these requirements into the New Hampshire SIP. This action is...

78 FR 30208 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Prevention of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2011-0467; EPA-R05-OAR-2012-0538; FRL-9808-9] Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Prevention of Significant Deterioration Greenhouse Gas Tailoring and Biomass Deferral Rule AGENCY: Environmental Protection...

Study on the Quality and Performance of CoCrMo Alloy Parts Manufactured by Selective Laser Melting

NASA Astrophysics Data System (ADS)

Guoqing, Zhang; Yongqiang, Yang; Hui, Lin; Changhui, Song; Zimian, Zhang

2017-05-01

To obtain medical implants with better performance, it is necessary to conduct studies on the quality and other performances of the selective laser melting (SLM) manufacturing parts. Interior defects in CoCrMo parts manufactured by SLM were detected using x-ray radiographic inspection, and the manufactured parts compared with three-dimensional models to assess manufacturing quality. Impact tests were employed to establish the mechanical properties of the manufactured parts. With the aim of studying the mechanism of fracture of the parts, we utilized a metalloscope and SEM to observe the surface and fractal theory was used to analyze the appearance of fractures. The results show that part defects manifested in an increase in transmittance caused by the non-uniform distribution of density, resulting in variation in the residual stresses of the parts. The density of the parts was more uniform following heat treatment. Internal residual stress of the manufactured parts enhanced their impact toughness. There was a ductile-brittle transition temperature between the two annealing temperatures. We determined that the fracture mechanism was brittle fracture. Fractures exhibited significant fractal behavior. The impact energy and fractal dimension were positively correlated, which provided good support for using selective laser melting manufacturing of CoCrMo alloy in medical implants.

46 CFR 54.01-18 - Plan approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Requirements § 54.01-18 Plan approval. (a) Manufacturers intending to fabricate pressure vessels, heat exchangers, evaporators, and similar appurtenances, covered by the regulations in this part shall submit...

46 CFR 54.01-18 - Plan approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Requirements § 54.01-18 Plan approval. (a) Manufacturers intending to fabricate pressure vessels, heat exchangers, evaporators, and similar appurtenances, covered by the regulations in this part shall submit...

46 CFR 54.01-18 - Plan approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Requirements § 54.01-18 Plan approval. (a) Manufacturers intending to fabricate pressure vessels, heat exchangers, evaporators, and similar appurtenances, covered by the regulations in this part shall submit...

46 CFR 54.01-18 - Plan approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Requirements § 54.01-18 Plan approval. (a) Manufacturers intending to fabricate pressure vessels, heat exchangers, evaporators, and similar appurtenances, covered by the regulations in this part shall submit...

46 CFR 54.01-18 - Plan approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Requirements § 54.01-18 Plan approval. (a) Manufacturers intending to fabricate pressure vessels, heat exchangers, evaporators, and similar appurtenances, covered by the regulations in this part shall submit...

78 FR 34306 - Approval and Promulgation of Air Quality Implementation Plans: North Carolina; Control Techniques...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

... Promulgation of Air Quality Implementation Plans: North Carolina; Control Techniques Guidelines and Reasonably Available Control Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY... Carolina's commitment associated with the conditional approval of its reasonably available control...

27 CFR 20.192 - Manufacturing record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ingredients used; and (c) Name, trade name or brand name and alcoholic content of each article or intermediate product manufactured, as applicable. (Approved by the Office of Management and Budget under control number...

Southern Pennsylvania's Industrial Pipeline: "Pathways" Program Helps Local Manufacturers Find Quality Workers

ERIC Educational Resources Information Center

Dixon, John; Girifalco, Tony; Yakabosky, Walt

2008-01-01

This article describes the Applied Engineering Technology (AET) Career and Educational Pathways Program, which helps local manufacturers find quality workers. The program features 32 high schools, three community colleges, and 10 four-year institutions offering an integrated regional system of applied engineering education. The goal is to enroll…

75 FR 20922 - Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Transportation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

... Promulgation of Air Quality Implementation Plans; New Mexico; Transportation Conformity Requirement for... of New Mexico on December 4, 2008 on behalf of the Albuquerque Environmental Health Department (AEHD... Mexico on May 15, 2003 and August 4, 2005. EPA is approving the December 4, 2008 revision in accordance...

30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

PubMed

Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

2017-01-01

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

49 CFR 450.12 - Criteria for selection of Approval Authorities.

Code of Federal Regulations, 2012 CFR

2012-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for... award of a specific contract to approve containers would not be a substantial factor in the financial... from influence or control of manufacturers, owners, operators or lessors of containers. (2) The person...

49 CFR 450.12 - Criteria for selection of Approval Authorities.

Code of Federal Regulations, 2014 CFR

2014-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for... award of a specific contract to approve containers would not be a substantial factor in the financial... from influence or control of manufacturers, owners, operators or lessors of containers. (2) The person...

49 CFR 450.12 - Criteria for selection of Approval Authorities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for... award of a specific contract to approve containers would not be a substantial factor in the financial... from influence or control of manufacturers, owners, operators or lessors of containers. (2) The person...

49 CFR 450.12 - Criteria for selection of Approval Authorities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for... award of a specific contract to approve containers would not be a substantial factor in the financial... from influence or control of manufacturers, owners, operators or lessors of containers. (2) The person...

49 CFR 450.12 - Criteria for selection of Approval Authorities.

Code of Federal Regulations, 2013 CFR

2013-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for... award of a specific contract to approve containers would not be a substantial factor in the financial... from influence or control of manufacturers, owners, operators or lessors of containers. (2) The person...

78 FR 63383 - Approval and Promulgation of Air Quality Implementation Plans; Rhode Island: Prevention of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

...] Approval and Promulgation of Air Quality Implementation Plans; Rhode Island: Prevention of Significant... revisions to the Rhode Island State Implementation Plan (SIP) primarily relating to regulation of Greenhouse Gases (GHGs) under Rhode Island's Prevention of Significant Deterioration (PSD) preconstruction...

Advances in clinical NK cell studies: Donor selection, manufacturing and quality control

PubMed Central

Koehl, U.; Kalberer, C.; Spanholtz, J.; Lee, D. A.; Miller, J. S.; Cooley, S.; Lowdell, M.; Uharek, L.; Klingemann, H.; Curti, A.; Leung, W.; Alici, E.

2016-01-01

ABSTRACT Natural killer (NK) cells are increasingly used in clinical studies in order to treat patients with various malignancies. The following review summarizes platform lectures and 2013–2015 consortium meetings on manufacturing and clinical use of NK cells in Europe and United States. A broad overview of recent pre-clinical and clinical results in NK cell therapies is provided based on unstimulated, cytokine-activated, as well as genetically engineered NK cells using chimeric antigen receptors (CAR). Differences in donor selection, manufacturing and quality control of NK cells for cancer immunotherapies are described and basic recommendations are outlined for harmonization in future NK cell studies. PMID:27141397

78 FR 44494 - Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

...EPA is proposing to approve, as a revision of the California state implementation plan, the State's request to redesignate the Sacramento nonattainment area to attainment for the 24-hour particulate matter of ten microns or less (PM10) National Ambient Air Quality Standard (NAAQS). EPA is also proposing to approve the PM10 maintenance plan and the associated motor vehicle emissions budgets for use in transportation conformity determinations necessary for the Sacramento area. Finally, EPA is proposing to approve the attainment year emissions inventory. EPA is proposing these actions because the SIP revision meets the requirements of the Clean Air Act and EPA guidance for such plans and motor vehicle emissions budgets.

30 CFR 20.13 - Approval plate.

Code of Federal Regulations, 2013 CFR

2013-07-01

... manufacturer shall attach, stamp, or mold an approval plate on the battery container or housing of each... identifies the lamp so that anyone can tell at a glance whether the lamp is of the permissible type or not...

30 CFR 20.13 - Approval plate.

Code of Federal Regulations, 2012 CFR

2012-07-01

... manufacturer shall attach, stamp, or mold an approval plate on the battery container or housing of each... identifies the lamp so that anyone can tell at a glance whether the lamp is of the permissible type or not...

30 CFR 20.13 - Approval plate.

Code of Federal Regulations, 2014 CFR

2014-07-01

... manufacturer shall attach, stamp, or mold an approval plate on the battery container or housing of each... identifies the lamp so that anyone can tell at a glance whether the lamp is of the permissible type or not...

30 CFR 20.13 - Approval plate.

Code of Federal Regulations, 2011 CFR

2011-07-01

... manufacturer shall attach, stamp, or mold an approval plate on the battery container or housing of each... identifies the lamp so that anyone can tell at a glance whether the lamp is of the permissible type or not...

76 FR 63549 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Miscellaneous Metal and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-13

... Promulgation of Air Quality Implementation Plans; Indiana; Miscellaneous Metal and Plastic Parts Surface... and plastic parts surface coating rules. These rules are approvable because they satisfy the... amendments added limits for miscellaneous metal and plastic parts surface coating operations, consistent with...

76 FR 41086 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Volatile Organic Compound...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... Promulgation of Air Quality Implementation Plans; Ohio; Volatile Organic Compound Reinforced Plastic Composites... compound (VOC) emissions from reinforced plastic composites production operations. This rule applies to any facility that has reinforced plastic composites production operations. This rule is approvable because it...

76 FR 6559 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations... Promulgation of Air Quality Implementation Plans; Pennsylvania; 2002 Base Year Emissions Inventory, Reasonable... revision. EPA is approving this SIP revision because it satisfies Clean Air Act (CAA) requirements for the...

Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel.

PubMed

Mahaguna, Vorapann; McDermott, J Mario; Zhang, Feng; Ochoa, Felipe

2004-01-01

The purpose of this investigation was to compare quality parameters, including product appearance, content uniformity, pH, weight uniformity, microbial limit testing and preservative effectiveness testing on extemporaneously compounded progesterone vaginal suppositories obtained from 10 randomly chosen compounding pharmacies (90 suppositories each) across the United States, to the Food and Drug Administration (FDA) approved prescription progesterone gel product (Prochieve/Crinone) which is manufactured in a cGMP regulated facility. The content uniformity and pH were determined using qualified methods. The microbial limits testing and preservative effectiveness testing were conducted according to compendial methods. Only one pharmacy provided suppositories that were all within the potency limits required for the prescription progesterone gel product. The other pharmacies provided at least some suppositories where progesterone content was either subpotent or superpotent for progesterone. The pH of most of the compounded suppository products was in the range of 4.22 to 7.68 with a median of 6.30 (normal vaginal pH is <5), whereas the gel product was 2.80. For compounded product from one of the pharmacies, microbial limits testing indicated CDC group IVC-2 and Comamonas acidovorans were detected. This data indicates that pharmacy compounded delivery systems for progesterone should be used with caution.

Applying Quality by Design Concepts to Pharmacy Compounding.

PubMed

Timko, Robert J

2015-01-01

Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S. Food and Drug Administration approval, a pharmacist has the responsibility to ensure that compounded medications are of suitable quality, safety, and efficacy. The Federal Government and numerous states have updated their laws and regulations regarding pharmacy compounding as a result of recent quality issues. Compounding pharmacists are expected to follow good preparation prodecures in their compounding practices in much the same way pharmaceutical manufacturers are required to follow Current Good Manufacturing Procedures as detailed in the United States Code of Federal Regulations. Application of Quality by Design concepts to the preparation process for a compounded medication can help in understanding the potential pitfalls and the means to mitigate their impact. The goal is to build quality into the compounding process to ensure that the resultant compounded prescription meets the human or animal patients' requirements.

75 FR 72963 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile Organic Compound Emissions From Industrial Solvent Cleaning Operations; Withdrawal of Direct Final Rule AGENCY: Environmental Protection... withdrawing the direct final rule to approve revisions to Maryland's State Implementation Plan (SIP). This SIP...

78 FR 46520 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Permit Exemption Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-01

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2008-0402; FRL-9834-4] Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Permit Exemption Rule AGENCY: Environmental.... WDNR submitted revisions exempting certain sources of air pollution from construction permit...

78 FR 25858 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Motor Vehicle...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-03

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2012-0954; FRL-9796-3] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Motor Vehicle Emissions Budgets for the Pennsylvania Counties in the Philadelphia-Wilmington, PA-NJ-DE 1997 Fine Particulate Matter Nonattainment Area Correction In rule document 2013-753...

75 FR 35454 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... Activities; Submission to OMB for Review and Approval; Comment Request; Aerospace Manufacturing and Rework...: Entities potentially affected by this action are owners or operators of existing aerospace manufacturing... Manufacturing. 336414 Guided Missile and Space Vehicle Manufacturing. 336415 Guided Missile and Space Vehicle...

78 FR 65875 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Removal of Gasoline...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

...] Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Removal of Gasoline Vapor... Administrative Code, Chapter NR 420 Control of Organic Compound Emissions from Petroleum and Gasoline Sources... FROM PETROLEUM AND GASOLINE SOURCES. NR 420.01 as published in the (Wisconsin) Register, February, 1990...

[The technicoregulatory situation in France for manufactured homeopathic medications].

PubMed

Santini, Cl

2005-06-01

Many homeopathic medications are marketed in France on the basis of old national regulations: homeopathic medications with a common denomination (unit or complex products) whose former approval was transformed into a marketing authorization in 1984; "normal formulations" with a special denomination, often dating from before 1941 (date when drug approval was instituted) including certain produces whose marketing approval was obtained under different mechanisms but still sold today. After the EEC excluded homeopathic drugs from the "medication" directives, in 1975 the 92/72/EEC directive stated that beyond the normal requirements for quality and safety, the same obligations could not be required for homeopathic and allopathic medications. A "registration" system was thus instituted for "traditional" medications en lieu of marketing approval. This included a dual obligation: 1) abstention from claiming therapeutic indications, 2) avoiding any formulation which could carry a risk for the patients (i.e. oral and topical formulations exclusive and degree of dilution guaranteeing safety). Beyond this restrictive framework, these medications have marketing approval, but, for the specific features of homeopathic medications, the directive leaves it up to the member States with a "homeopathic tradition" to apply special rules for evaluating the results of clinical trials designed to establish safety and efficacy. For the efficacy feature, traditional use can be used as an argument for marketing approval (article R5143 CSP). In order to create a more rational technicoregulatory environment, older products marketed before 1994 are being "validated" by group according to a calendar established in 2003 and which should run from 2004 to 2012. At the end of this validation procedure, all manufactured homeopathic products will either receive marketing approval or be recorder in compliance with general or specific European regulations. In conclusion, we make a few personal comments

76 FR 11082 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Oxides of Nitrogen Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-01

... Promulgation of Air Quality Implementation Plans; Ohio; Oxides of Nitrogen Budget Trading Program; Technical... concerning 240 allowances under the Nitrogen Oxides Budget Trading Program added to the SIP by EPA rulemaking... EPA approve rule revisions [[Page 11083

76 FR 53369 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

... Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and Sealants Rule AGENCY... Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania. The SIP revision pertains to... volatile organic compounds (VOC) from the manufacture, sale, use, or application of adhesives, sealants...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

21 CFR 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING..., rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the... pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for...

46 CFR 160.049-7 - Procedure for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-7... be granted separately to each manufacturer for each unicellular plastic foam buoyant cushion he...

46 CFR 160.049-7 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-7... be granted separately to each manufacturer for each unicellular plastic foam buoyant cushion he...

46 CFR 160.049-7 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-7... be granted separately to each manufacturer for each unicellular plastic foam buoyant cushion he...

Developing Countries Vaccine Manufacturers Network: doing good by making high-quality vaccines affordable for all.

PubMed

Pagliusi, Sonia; Leite, Luciana C C; Datla, Mahima; Makhoana, Morena; Gao, Yongzhong; Suhardono, Mahendra; Jadhav, Suresh; Harshavardhan, Gutla V J A; Homma, Akira

2013-04-18

The Developing Countries Vaccine Manufacturers Network (DCVMN) is a unique model of a public and private international alliance. It assembles governmental and private organizations to work toward a common goal of manufacturing and supplying high-quality vaccines at affordable prices to protect people around the world from known and emerging infectious diseases. Together, this group of manufacturers has decades of experience in manufacturing vaccines, with technologies, know-how, and capacity to produce more than 40 vaccines types. These manufacturers have already contributed more than 30 vaccines in various presentations that have been prequalified by the World Health Organization for use by global immunization programmes. Furthermore, more than 45 vaccines are in the pipeline. Recent areas of focus include vaccines to protect against rotavirus, human papillomavirus (HPV), Japanese encephalitis, meningitis, hepatitis E, poliovirus, influenza, and pertussis, as well as combined pentavalent vaccines for children. The network has a growing number of manufacturers that produce a growing number of products to supply the growing demand for vaccines in developing countries. Copyright © 2013. Published by Elsevier Ltd.

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein

PubMed Central

McCue, J; Osborne, D; Dumont, J; Peters, R; Mei, B; Pierce, G F; Kobayashi, K; Euwart, D

2014-01-01

Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing process utilized a transferable and scalable platform approach established for therapeutic antibody manufacturing and adapted for production of the rFIXFc molecule. rFIXFc was produced using a process free of human- and animal-derived raw materials and a host cell line derived from human embryonic kidney (HEK) 293H cells. The process employed multi-step purification and viral clearance processing, including use of a protein A affinity capture chromatography step, which binds to the Fc portion of the rFIXFc molecule with high affinity and specificity, and a 15 nm pore size virus removal nanofilter. Process validation studies were performed to evaluate identity, purity, activity and safety. The manufacturing process produced rFIXFc with consistent product quality and high purity. Impurity clearance validation studies demonstrated robust and reproducible removal of process-related impurities and adventitious viruses. The rFIXFc manufacturing process produces a highly pure product, free of non-human glycan structures. Validation studies demonstrate that this product is produced with consistent quality and purity. In addition, the scalability and transferability of this process are key attributes to ensure consistent and continuous supply of rFIXFc. PMID:24811361

76 FR 52283 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Control of Nitrogen...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... Promulgation of Air Quality Implementation Plans; Pennsylvania; Control of Nitrogen Oxides Emissions From Glass... revisions pertain to the control of nitrogen oxide (NO X ) emissions from glass melting furnaces. EPA is approving these revisions to reduce NO X emissions from glass melting furnaces in accordance with the...

76 FR 41739 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Determination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-15

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2011-0454; FRL-9439-9] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Determination of Attainment and Determination of Clean Data for the Annual 1997 Fine Particle Standard for the Charleston Area AGENCY...

76 FR 5078 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; The Milwaukee-Racine...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2010-0850; FRL-9258-7] Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; The Milwaukee-Racine and Sheboygan Areas... determinations under the Clean Air Act that the Milwaukee-Racine and Sheboygan, Wisconsin areas have attained the...

78 FR 6096 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-29

... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Miscellaneous Organic Chemical Manufacturing (Renewal) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: In... review and approval. This is a request to renew an existing approved collection. The ICR which is...

75 FR 20837 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-21

... Approval; Comment Request; NESHAP for Magnetic Tape Manufacturing Operations AGENCY: Environmental... electronic docket, go to http://www.regulations.gov . Title: NESHAP for Magnetic Tape Manufacturing.../Affected Entities: Magnetic tape manufacturing operations. Estimated Number of Respondents: 6. Frequency of...

Initiatives to Improve Quality of Additively Manufactured Parts

NASA Technical Reports Server (NTRS)

Waller, Jess; Nichols, Charles

2017-01-01

NASA is providing leadership in an international effort linking government and industry resources to speed adoption of additive manufactured (AM) parts. Participants include government agencies (NASA, USAF, NIST, FAA), industry (commercial aerospace, NDE manufacturers, AM equipment manufacturers), standards organizations and academia. NASA is also partnering with its international space exploration organizations such as ESA and JAXA. NDT is identified as a universal need for all aspects of additive manufacturing.

76 FR 40246 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Control of Gasoline...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2006-0976; FRL-9430-5] Approval and Promulgation of Air Quality Implementation Plans; Ohio; Control of Gasoline Volatility; Correction AGENCY... a gasoline Reid Vapor Pressure (RVP) limit of 7.8 pounds per square inch (psi) for gasoline sold in...

A risk-based auditing process for pharmaceutical manufacturers.

PubMed

Vargo, Susan; Dana, Bob; Rangavajhula, Vijaya; Rönninger, Stephan

2014-01-01

The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.

75 FR 59710 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... Approval; Comment Request; Aerospace Manufacturing and Rework Industry Information Collection AGENCY... electronic docket, go to http://www.regulations.gov . Title: Aerospace Manufacturing and Rework Industry... manufacturing and rework facilities and has been tailored to the processes at aerospace facilities. Respondents...

Additive Manufacturing: Ensuring Quality for Spacecraft Applications

NASA Technical Reports Server (NTRS)

Swanson, Theodore; Stephenson, Timothy

2014-01-01

Reliable manufacturing requires that material properties and fabrication processes be well defined in order to insure that the manufactured parts meet specified requirements. While this issue is now relatively straightforward for traditional processes such as subtractive manufacturing and injection molding, this capability is still evolving for AM products. Hence, one of the principal challenges within AM is in qualifying and verifying source material properties and process control. This issue is particularly critical for applications in harsh environments and demanding applications, such as spacecraft.

Digital mammography. Why hasn't it been approved for U.S. hospitals?

PubMed

2000-01-01

Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

76 FR 71455 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-18

...EPA is taking final action to approve a request submitted on December 18, 2009, and supplemented on December 22, 2010, from the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (DAQ), to redesignate the Greensboro-Winston-Salem-High Point fine particulate matter (PM2.5) nonattainment area (hereafter the ``Greensboro Area'' or ``Area'') to attainment for the 1997 Annual PM2.5 National Ambient Air Quality Standards (NAAQS). The Greensboro Area is comprised of Davidson and Guilford Counties in their entireties. EPA's approval of the redesignation request is based on the determination that the State of North Carolina has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA or Act), including the determination that the Greensboro Area has attained the 1997 Annual PM2.5 NAAQS by its applicable attainment date of April 5, 2010. Additionally, EPA is approving a revision to the North Carolina State Implementation Plan (SIP) to include the 1997 Annual PM2.5 maintenance plan for the Greensboro Area that contains the new 2011 and 2021 motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) and PM2.5 for both Davidson and Guilford Counties. This action also approves the emissions inventory submitted with the maintenance plan. Further, EPA is correcting a typographical error for the citation associated with a previous adequacy finding the Agency made for the NOX and PM2.5 MVEBs for both Davidson and Guilford Counties.

49 CFR 178.69 - Responsibilities and requirements for manufacturers of UN pressure receptacles.

Code of Federal Regulations, 2014 CFR

2014-10-01

... manufacturers of UN pressure receptacles. 178.69 Section 178.69 Transportation Other Regulations Relating to... requirements for manufacturers of UN pressure receptacles. (a) Each manufacturer of a UN pressure receptacle marked with “USA” as a country of approval must comply with the requirements in this section. The...

49 CFR 178.69 - Responsibilities and requirements for manufacturers of UN pressure receptacles.

Code of Federal Regulations, 2011 CFR

2011-10-01

... manufacturers of UN pressure receptacles. 178.69 Section 178.69 Transportation Other Regulations Relating to... requirements for manufacturers of UN pressure receptacles. (a) Each manufacturer of a UN pressure receptacle marked with “USA” as a country of approval must comply with the requirements in this section. The...

49 CFR 178.69 - Responsibilities and requirements for manufacturers of UN pressure receptacles.

Code of Federal Regulations, 2013 CFR

2013-10-01

... manufacturers of UN pressure receptacles. 178.69 Section 178.69 Transportation Other Regulations Relating to... requirements for manufacturers of UN pressure receptacles. (a) Each manufacturer of a UN pressure receptacle marked with “USA” as a country of approval must comply with the requirements in this section. The...

49 CFR 178.69 - Responsibilities and requirements for manufacturers of UN pressure receptacles.

Code of Federal Regulations, 2012 CFR

2012-10-01

... manufacturers of UN pressure receptacles. 178.69 Section 178.69 Transportation Other Regulations Relating to... requirements for manufacturers of UN pressure receptacles. (a) Each manufacturer of a UN pressure receptacle marked with “USA” as a country of approval must comply with the requirements in this section. The...

The Manufacture, Shipping and Receiving and Quality Control of Rodent Bedding Materials

NASA Technical Reports Server (NTRS)

Kraft, Lisbeth M.

1980-01-01

The criteria for rodent bedding and nesting materials are discussed. The literature is reviewed regarding sources of bedding materials, manufacturing methods, quality control, procedures (microbiological, physical and chemical), storage, methods, shipment, methods of use and disposal, current knowledge concerning bedding effects on animals as related to research and testing and legal aspects. Future needs, especially with respect to the promulgation of standards, also are addressed.

75 FR 28802 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-24

... Approval; Comment Request; NESHAP for the Manufacture of Amino/Phenolic Resins AGENCY: Environmental... . Title: NESHAP for the Manufacture of Amino/Phenolic Resins (Renewal). ICR Numbers: EPA ICR Number 1869.... Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Manufacture of...

78 FR 5859 - Agency Information Collection Activities: Requests for Comments; Clearance of New Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... about our intention to request the Office of Management and Budget (OMB) approval for a new information... propeller critical parts by the manufacturer, and establish engineering, manufacture, and maintenance... their manuals to record engineering, manufacture, and maintenance processes for propeller critical parts...

77 FR 56124 - Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD and NSR Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... Promulgation of Air Quality Implementation Plans; Michigan; PSD and NSR Regulations AGENCY: Environmental... the prevention of significant deterioration (PSD) construction permit program for the purpose of... approving Michigan's request to revise its SIP to add rule R. 336.2816 to be consistent with Federal PSD...

76 FR 43149 - Approval and Promulgation of Air Quality Implementation Plans; State of California; Regional Haze...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2011-0131, FRL-9317-9] Approval and Promulgation of Air Quality Implementation Plans; State of California; Regional Haze State Implementation Plan and Interstate Transport Plan; Interference With Visibility Requirement Correction In rule document...

[Chinese medicine industry 4.0：advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

PubMed

Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

2016-01-01

A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.

Product quality considerations for mammalian cell culture process development and manufacturing.

PubMed

Gramer, Michael J

2014-01-01

The manufacturing of a biologic drug from mammalian cells results in not a single substance, but an array of product isoforms, also known as variants. These isoforms arise due to intracellular or extracellular events as a result of biological or chemical modification. The most common examples related to biomanufacturing include amino acid modifications (glycosylation, isomerization, oxidation, adduct formation, pyroglutamate formation, phosphorylation, sulfation, amidation), amino acid sequence variants (genetic mutations, amino acid misincorporation, N- and C-terminal heterogeneity, clipping), and higher-order structure modifications (misfolding, aggregation, disulfide pairing). Process-related impurities (HCP, DNA, media components, viral particles) are also important quality attributes related to product safety. The observed ranges associated with each quality attribute define the product quality profile. A biologic drug must have a correct and consistent quality profile throughout clinical development and scale-up to commercial production to ensure product safety and efficacy. In general, the upstream process (cell culture) defines the quality of product-related substances, whereas the downstream process (purification) defines the residual level of process- and product-related impurities. The purpose of this chapter is to review the impact of the cell culture process on product quality. Emphasis is placed on studies with industrial significance and where the direct mechanism of product quality impact was determined. Where possible, recommendations for maintaining consistent or improved quality are provided.

A Novel Method for Fabricating Additive Manufactured Lightweight, Optical Quality Metallic Mirrors

DTIC Science & Technology

2016-01-04

lighter  mirrors  can  lead to great reductions of mass in full systems [3,4].    The state of the art in this industry is ULE™,  Zerodur ™, or beryllium...1    A Novel Method for Fabricating Additive Manufactured  Lightweight, Optical Quality Metallic  Mirrors   Michael Stern, Joseph Bari  Distribution A...metallic  mirrors  fabricated by growing an additive manufactured blank, post  processing the faces, coating with electroless nickel, and diamond turning

Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

PubMed Central

Morrison, Robert J.; Kashlan, Khaled N.; Flanangan, Colleen L.; Wright, Jeanne K.; Green, Glenn E.; Hollister, Scott J.

2015-01-01

Abstract Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device. PMID:26243449

30 CFR 28.21 - Certificates of approval; contents.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROTECTION FOR TRAILING CABLES IN COAL MINES Approval and Disapproval § 28.21 Certificates of approval... protection for trailing cables. (c) Each certificate of approval shall be accompanied by a reproduction of... certificate of approval shall also contain the approved quality control plan as specified in § 28.31. ...

30 CFR 28.21 - Certificates of approval; contents.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROTECTION FOR TRAILING CABLES IN COAL MINES Approval and Disapproval § 28.21 Certificates of approval... protection for trailing cables. (c) Each certificate of approval shall be accompanied by a reproduction of... certificate of approval shall also contain the approved quality control plan as specified in § 28.31. ...

30 CFR 28.21 - Certificates of approval; contents.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROTECTION FOR TRAILING CABLES IN COAL MINES Approval and Disapproval § 28.21 Certificates of approval... protection for trailing cables. (c) Each certificate of approval shall be accompanied by a reproduction of... certificate of approval shall also contain the approved quality control plan as specified in § 28.31. ...

30 CFR 28.21 - Certificates of approval; contents.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROTECTION FOR TRAILING CABLES IN COAL MINES Approval and Disapproval § 28.21 Certificates of approval... protection for trailing cables. (c) Each certificate of approval shall be accompanied by a reproduction of... certificate of approval shall also contain the approved quality control plan as specified in § 28.31. ...

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein.

PubMed

McCue, J; Osborne, D; Dumont, J; Peters, R; Mei, B; Pierce, G F; Kobayashi, K; Euwart, D

2014-07-01

Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing process utilized a transferable and scalable platform approach established for therapeutic antibody manufacturing and adapted for production of the rFIXFc molecule. rFIXFc was produced using a process free of human- and animal-derived raw materials and a host cell line derived from human embryonic kidney (HEK) 293H cells. The process employed multi-step purification and viral clearance processing, including use of a protein A affinity capture chromatography step, which binds to the Fc portion of the rFIXFc molecule with high affinity and specificity, and a 15 nm pore size virus removal nanofilter. Process validation studies were performed to evaluate identity, purity, activity and safety. The manufacturing process produced rFIXFc with consistent product quality and high purity. Impurity clearance validation studies demonstrated robust and reproducible removal of process-related impurities and adventitious viruses. The rFIXFc manufacturing process produces a highly pure product, free of non-human glycan structures. Validation studies demonstrate that this product is produced with consistent quality and purity. In addition, the scalability and transferability of this process are key attributes to ensure consistent and continuous supply of rFIXFc. © 2014 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

75 FR 23263 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-03

... Approval; Comment Request; NSPS for Lead Acid Battery Manufacturing (Renewal) AGENCY: Environmental... electronic docket, go to http://www.regulations.gov . Title: NSPS for Lead Acid Battery Manufacturing... Battery Manufacturing (40 CFR part 60, subpart KK) were proposed on January 14, 1980, and promulgated on...

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.

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

24 CFR 3282.203 - DAPIA services.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Requirements § 3282.203 DAPIA services. (a) Each manufacturer shall have each manufactured home design and each... is free to choose which DAPIA will evaluate and approve its designs and quality assurance materials manufacturer may obtain design and quality assurance manual approval from a single DAPIA regardless of the...

77 FR 16937 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Regional Haze State...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... Promulgation of Air Quality Implementation Plans; West Virginia; Regional Haze State Implementation Plan AGENCY... limited disapproval of West Virginia's Regional Haze State Implementation Plan (SIP) revision. EPA is... mandatory Class I areas through a regional haze program. EPA is also approving this revision as meeting the...

75 FR 57186 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-0203-201035; FRL-9202-9] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes... determination that the Birmingham, Alabama, nonattainment area has attained the 24-hour fine particulate matter...

76 FR 31239 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... 40 CFR 52.1004(c), suspends the requirements for this area to submit an attainment demonstration... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2011-0084-201135; FRL- 9312-5] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning...

75 FR 21197 - Approval and Promulgation of Air Quality Implementation Plans; New Mexico; Revisions to New...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-23

... Promulgation of Air Quality Implementation Plans; New Mexico; Revisions to New Mexico Transportation Conformity... approve revisions to the New Mexico State Implementation Plan (SIP) concerning the State transportation... action on SIP revisions pertaining to the State of New Mexico. We have published a direct final rule...

40 CFR 52.1623 - Conditional approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1623 Conditional approval. (a) General Conformity. (1) A letter, dated April 22, 1998, from the Chief of Air Quality Bureau New Mexico... to withdraw its approval. The FAA had commented that New Mexico was more stringent than EPA, since...

40 CFR 52.1623 - Conditional approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1623 Conditional approval. (a) General Conformity. (1) A letter, dated April 22, 1998, from the Chief of Air Quality Bureau New Mexico... to withdraw its approval. The FAA had commented that New Mexico was more stringent than EPA, since...

78 FR 75342 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-11

... Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Lime Manufacturing (Renewal... Agency has submitted an information collection request (ICR), ``NESHAP for Lime Manufacturing (40 CFR... required semiannually. Form Numbers: None. Respondents/affected entities: Lime manufacturing plants...

49 CFR 107.807 - Approval of non-domestic chemical analyses and tests.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 2 2013-10-01 2013-10-01 false Approval of non-domestic chemical analyses and... Requalifiers, and Non-domestic Chemical Analyses and Tests of DOT Specification Cylinders § 107.807 Approval of non-domestic chemical analyses and tests. (a) General. A person who seeks to manufacture DOT...

76 FR 71452 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-18

...EPA is taking final action to approve a request submitted on December 18, 2009, and supplemented on December 22, 2010, from the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (DAQ), to redesignate the Hickory-Morganton-Lenoir fine particulate matter (PM2.5) nonattainment area (hereafter the ``Hickory Area'' or ``Area'') to attainment for the 1997 Annual PM2.5 National Ambient Air Quality Standards (NAAQS). The Hickory Area is comprised of Catawba County in its entirety. EPA's approval of the redesignation request is based on the determination that the State of North Carolina has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA or Act), including the determination that the Hickory Area has attained the 1997 Annual PM2.5 NAAQS by its applicable attainment date of April 5, 2010. Additionally, EPA is approving a revision to the North Carolina State Implementation Plan (SIP) to include the 1997 Annual PM2.5 maintenance plan for the Hickory Area that contains the new motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) for the years 2011 and 2021 for Catawba County and the mobile insignificance determination for direct PM2.5 for the Hickory Area. This action also approves the emissions inventory submitted with the maintenance plan. Further, EPA is correcting a typographical error for the citation associated with a previous adequacy determination the Agency made for the NOX MVEBs for Catawba County and the mobile source insignificance determination for direct PM2.5 for the Hickory Area.

78 FR 59841 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; West Virginia's...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-30

...EPA is approving a redesignation request and State Implementation Plan (SIP) revision submitted by the State of West Virginia. The West Virginia Department of Environmental Protection (WVDEP) requested that the West Virginia portion of the Wheeling, WV-OH fine particulate matter (PM2.5) nonattainment area (``Wheeling Area'' or ``Area'') be redesignated as attainment for the 1997 annual PM2.5 national ambient air quality standard (NAAQS). In this rulemaking action, EPA is approving the 1997 annual PM2.5 redesignation request for the West Virginia portion of the Area. EPA is also approving the maintenance plan SIP revision that the State submitted in conjunction with its redesignation request. The maintenance plan provides for continued attainment of the 1997 annual PM2.5 NAAQS for 10 years after redesignation of the West Virginia portion of the Area. The maintenance plan includes a comprehensive emissions inventory that EPA is approving in this rulemaking. The maintenance plan also includes an insignificance determination for the onroad motor vehicle contribution of PM2.5, nitrogen oxides (NOX), and sulfur dioxide (SO2) for the West Virginia portion of the Area for purposes of transportation conformity. EPA is also approving West Virginia's insignificance determination for transportation conformity. In addition, EPA is also finding that the Area continues to attain the standard. This rulemaking action approving the 1997 annual PM2.5 NAAQS redesignation request, maintenance plan, comprehensive emissions inventory, and insignificance determination for transportation conformity for the West Virginia portion of the Area is based on EPA's determination that the Area has met the criteria for redesignation to attainment specified in the Clean Air Act (CAA).

76 FR 36873 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-23

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-1036-201138; FRL-9322-4] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes... Atlanta, Georgia 1997 8-hour ozone nonattainment area has attained the 1997 8- hour ozone national ambient...

76 FR 31858 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... accordance with 40 CFR 52.1004(c), suspends the requirements for this area to submit an attainment... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2011-0055-201136; FRL-9313-8] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes...

75 FR 6336 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Removal of NOX

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... Promulgation of Air Quality Implementation Plans; West Virginia; Removal of NOX SIP Call Rules AGENCY... Implementation Plan (SIP) revision submitted by the State of West Virginia that removes West Virginia's nitrogen oxides (NOx) SIP Call rules. In the Final Rules section of this Federal Register, EPA is approving the...

75 FR 18142 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2006-0988; FRL-9135-5] Approval and Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution From Motor Vehicles AGENCY... (TAC), Chapter 114, Control of Air Pollution from Motor Vehicles. The State submitted these revisions...

76 FR 13569 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the Open...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2010-0903; FRL-9278-6] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the Open Burning Regulations AGENCY... burning regulations which are currently in the Virginia SIP. There are no substantive changes to the rule...

75 FR 32857 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to Clean Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-10

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2009-0599; FRL-9125-2] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to Clean Air Interstate Rule Sulfur Dioxide Trading Program Correction In final rule document 2010-5105 beginning on page 11738 in the issue...

78 FR 73524 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

... Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Rubber Tire Manufacturing... Protection Agency has submitted an information collection request (ICR), ``NSPS for Rubber Tire Manufacturing.../dockets . Abstract: Respondents are owners or operators of rubber tire manufacturing plants which include...

77 FR 429 - Clarification and Further Guidance on the Fireworks Approvals Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-05

...) and the American Pyrotechnic Association (APA) Standard 87-1. PHMSA understands that it is a common... approval is requested conforms to the APA Standard 87-1, and the descriptions and technical information... manufacturer must sign and certify that the device for which the approval is requested conforms to the APA...

76 FR 72675 - Foreign-Trade Zone 277, Temporary/Interim Manufacturing Authority, Sub-Zero, Inc., (Refrigerators...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-25

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Docket T-5-2011] Foreign-Trade Zone 277, Temporary/Interim Manufacturing Authority, Sub-Zero, Inc., (Refrigerators), Notice of Approval On October 3... manufacturing (T/IM) authority, on behalf of Sub- Zero, Inc., to manufacture refrigerators under FTZ procedures...

75 FR 59973 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

...; Cleaning of high precision optics; Stripping; Janitorial cleaning; cleaning of resin, coating, ink, and... laboratories; Cleaning operations in medical device or pharmaceutical manufacturing; and Cleaning operations related to performance or quality assurance testing of coatings, inks, or adhesives. COMAR 26.11.19.09-1...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

Arizona Air Quality State Implementation Plans; Final Approval; Douglas, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plan

EPA Pesticide Factsheets

EPA is taking final rulemaking action to approve, as part of the State Implementation Plan (SIP) for the State of Arizona, the second 10-year maintenance plan for the Douglas maintenance area for the 1971 National Ambient Air Quality Standards for SO2.

78 FR 45135 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Dayton...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

...EPA is proposing to approve the State of Ohio's request to redesignate the Dayton-Springfield nonattainment area (Dayton) to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). EPA is also proposing to approve the related elements including emissions inventories, maintenance plans, and the accompanying motor vehicle budgets. EPA is proposing to approve a comprehensive emissions inventory that meets the Clean Air Act (CAA) requirement. EPA is proposing that the inventories for nitrogen oxides (NOX), direct PM2.5, sulfur dioxide (SO2), ammonia, and volatile organic compounds (VOC) meet the CAA emissions inventory requirement. In the course of proposing to approve Ohio's request to redesignate the Dayton area, EPA addresses a number of additional issues, including the effects of two decisions of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court): (1) The Court's August 21, 2012, decision to vacate and remand to EPA the Cross-State Air Pollution Control Rule (CSAPR) and (2) the Court's January 4, 2013, decision to remand to EPA two final rules implementing the 1997 PM2.5 standard.

76 FR 18650 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

... determination, in accordance with 40 CFR 52.1004(c), suspends the requirements for this area to submit an... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-0798-201048; FRL-9288-8] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes...

77 FR 73313 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-10

... Promulgation of Air Quality Implementation Plans; Maryland; The 2002 Base Year Inventory for the Baltimore, MD... approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the State of... Department of the Environment (MDE), on June 6, 2008 for Baltimore, Maryland. The emissions inventory is part...

75 FR 50711 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Final Approval and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-17

... conditional approval of portions of OAC rule 3745-21-09. You can learn more information about the rule...). ACTION: Final rule. SUMMARY: Under section 110(k)(3) of the Clean Air Act (CAA), EPA is disapproving an...) of the CAA, we are also conditionally approving a revision of paragraph (BBB)(1) of OAC 3745-21-09...

Pharmaceutical product development: A quality by design approach

PubMed Central

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Pharmaceutical product development: A quality by design approach.

PubMed

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

77 FR 3691 - Approval and Promulgation of Air Quality Implementation Plans; Commonwealth of Virginia; Regional...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

...EPA is proposing a limited approval and a limited disapproval of six revisions to the Virginia State Implementation Plan (SIP) submitted by the Commonwealth of Virginia, through the Department of Environmental Quality (VADEQ), that address regional haze for the first implementation period. These revisions address the requirements of the Clean Air Act (CAA or Act) and EPA's rules that require states to prevent any future and remedy any existing anthropogenic impairment of visibility in mandatory Class I areas (national parks and wilderness areas) caused by emissions of air pollutants from numerous sources located over a wide geographic area (also referred to as the ``regional haze program''). States are required to assure reasonable progress toward the national goal of achieving natural visibility conditions in Class I areas. EPA is proposing a limited approval of these SIP revisions to implement the regional haze requirements for Virginia on the basis that the revisions, as a whole, strengthen the Virginia SIP. Also in this action, EPA is proposing a limited disapproval of these same SIP revisions because of the deficiencies in the Commonwealth's regional haze SIP submittal arising from the remand by the U.S. Court of Appeals for the District of Columbia (DC Circuit) to EPA of the Clean Air Interstate Rule (CAIR). EPA is also proposing to approve this revision as meeting the infrastructure requirements relating to visibility protection for the 1997 8-Hour Ozone National Ambient Air Quality Standard (NAAQS) and the 1997 and 2006 fine particulate matter (PM2.5) NAAQS.

77 FR 76415 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Redesignation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-28

...EPA is approving a redesignation request and State Implementation Plan (SIP) revision submitted by the State of West Virginia. The West Virginia Department of Environmental Protection (WVDEP) requested that the West Virginia portion of the Huntington- Ashland, WV-KY-OH fine particulate matter (PM2.5) nonattainment area (``Huntington-Ashland Area'' or ``Area'') be redesignated as attainment for the 1997 annual PM2.5 national ambient air quality standard (NAAQS). In this rulemaking action, EPA is approving the 1997 annual PM2.5 redesignation request for the West Virginia portion of the Area. EPA is also approving the maintenance plan SIP revision that the State submitted in conjunction with its redesignation request. The maintenance plan provides for continued attainment of the 1997 annual PM2.5 NAAQS for 10 years after redesignation of the West Virginia portion of the Area. The maintenance plan includes an insignificance determination for the onroad motor vehicle contribution of PM2.5, nitrogen oxides (NOX), and sulfur dioxide (SO2) for the West Virginia portion of the Area for purposes of transportation conformity. EPA is approving West Virginia's insignificance determination for transportation conformity. EPA is also finding that the Area continues to attain the standard. This rulemaking action approving the 1997 annual PM2.5 NAAQS redesignation request, maintenance plan, and insignificance determination for transportation conformity for the West Virginia portion of the Area is based on EPA's determination that the Area has met the criteria for redesignation to attainment specified in the Clean Air Act (CAA).

14 CFR 21.617 - Issue of letters of TSO design approval: import appliances.

Code of Federal Regulations, 2010 CFR

2010-01-01

...: import appliances. 21.617 Section 21.617 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... Order Authorizations § 21.617 Issue of letters of TSO design approval: import appliances. (a) A letter of TSO design approval may be issued for an appliance that is manufactured in a foreign country with...

75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-29

..., and Approval of Mining Products AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION..., evaluating, and approving mining products as provided by 30 CFR part 5. MSHA charges applicants a fee to... materials manufactured for use in the mining industry. The new fee schedule, effective January 1, 2011, is...

40 CFR 82.160 - Approved equipment testing organizations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction § 82.160 Approved.... The application shall be mailed to: Section 608 Recycling Program Manager; Global Programs Division... verifying the performance of certified recycling and recovery equipment manufactured over the long term...

40 CFR 82.160 - Approved equipment testing organizations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction § 82.160 Approved.... The application shall be mailed to: Section 608 Recycling Program Manager; Global Programs Division... verifying the performance of certified recycling and recovery equipment manufactured over the long term...

40 CFR 82.160 - Approved equipment testing organizations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction § 82.160 Approved.... The application shall be mailed to: Section 608 Recycling Program Manager; Global Programs Division... verifying the performance of certified recycling and recovery equipment manufactured over the long term...

40 CFR 82.160 - Approved equipment testing organizations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction § 82.160 Approved.... The application shall be mailed to: Section 608 Recycling Program Manager; Global Programs Division... verifying the performance of certified recycling and recovery equipment manufactured over the long term...

40 CFR 82.160 - Approved equipment testing organizations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction § 82.160 Approved.... The application shall be mailed to: Section 608 Recycling Program Manager; Global Programs Division... verifying the performance of certified recycling and recovery equipment manufactured over the long term...

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Additive Manufacturing Infrared Inspection

NASA Technical Reports Server (NTRS)

Gaddy, Darrell; Nettles, Mindy

2015-01-01

The Additive Manufacturing Infrared Inspection Task started the development of a real-time dimensional inspection technique and digital quality record for the additive manufacturing process using infrared camera imaging and processing techniques. This project will benefit additive manufacturing by providing real-time inspection of internal geometry that is not currently possible and reduce the time and cost of additive manufactured parts with automated real-time dimensional inspections which deletes post-production inspections.

46 CFR 160.072-09 - Manufacturer notification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Manufacturer notification. 160.072-09 Section 160.072-09 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Distress Signals for Boats, Orange Flag § 160.072-09...

77 FR 50608 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Hot Mix Asphalt Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... and Promulgation of Air Quality Implementation Plans; New Hampshire; Hot Mix Asphalt Plants AGENCY... is approving a revision to New Hampshire's regulation Env-A 2703.02 for hot mix asphalt plants. This rule establishes and requires limitations on visible emissions from all hot mix asphalt plants. This...

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

78 FR 54891 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

... Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for the Manufacture of Amino... Manufacture of Amino/Phenolic Resins (40 CFR Part 63, Subpart OOO) (Renewal)'' (EPA ICR No. 1869.07, OMB... the Manufacture of Amino/Phenolic Resins were proposed on December 14, 1998, and promulgated on...

Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

PubMed Central

Chollet, John L.; Jozwiakowski, Michael J.

2012-01-01

The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

40 CFR 1065.12 - Approval of alternate procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... POLLUTION CONTROLS ENGINE-TESTING PROCEDURES Applicability and General Provisions § 1065.12 Approval of... individual engine manufacturer may request to use an alternate procedure. This also means that an instrument... show that your engines comply with all applicable emission standards. (3) Any relevant factors...

40 CFR 1065.12 - Approval of alternate procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... POLLUTION CONTROLS ENGINE-TESTING PROCEDURES Applicability and General Provisions § 1065.12 Approval of... individual engine manufacturer may request to use an alternate procedure. This also means that an instrument... show that your engines comply with all applicable emission standards. (3) Any relevant factors...

40 CFR 1065.12 - Approval of alternate procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... POLLUTION CONTROLS ENGINE-TESTING PROCEDURES Applicability and General Provisions § 1065.12 Approval of... individual engine manufacturer may request to use an alternate procedure. This also means that an instrument... show that your engines comply with all applicable emission standards. (3) Any relevant factors...

Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

77 FR 50651 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Hot Mix Asphalt Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... and Promulgation of Air Quality Implementation Plans; New Hampshire; Hot Mix Asphalt Plants AGENCY.... Specifically, EPA is proposing to approve amendments to the New Hampshire Hot Mix Asphalt Plant Rule at Env-A 2703.02(a). This rule establishes and requires limitations on visible emissions from all hot mix...

77 FR 75933 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Emissions Inventory for the...: Proposed rule. SUMMARY: EPA is proposing to approve the 2002 base year emissions inventory portion of the... inventory is part of a SIP revision that was submitted to meet West Virginia's nonattainment requirements...

77 FR 37000 - Proposed Extension of Approval of Information Collection; Comment Request-Baby Bouncers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection... of 3 years from the date of approval by the Office of Management and Budget (OMB), of information... walker- jumpers. The collection of information consists of requirements that manufacturers and importers...

Medical devices manufactured from latex: European regulatory initiatives.

PubMed

De Jong, W H; Geertsma, R E; Tinkler, J J B

2002-05-01

In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be fulfilled by using the relevant harmonized European standards. These standards are regularly under revision to incorporate the latest scientific developments. For certain devices, for example, latex medical (examination and surgical) gloves, specific standards have been published. Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate type allergy) and against chemicals added during processing (type IV or delayed type hypersensitivity) present as residues in the latex products. So, besides requirements for product quality in terms of barrier properties, strength, and sterility, the main focus consists of the allergy-inducing properties of the latex products. Recent developments have reopened the discussion on the value of total protein versus allergen determination in latex medical gloves. However, as long as minimal levels needed for both sensitization and elicitation have not been established, a safe maximum level for leachable proteins/allergens in latex products cannot be determined. A European Commission guidance document on the latex allergy problem is currently being drafted by experts from Competent Authorities. Copyright 2002 Elsevier Science (USA).

A Process Management System for Networked Manufacturing

NASA Astrophysics Data System (ADS)

Liu, Tingting; Wang, Huifen; Liu, Linyan

With the development of computer, communication and network, networked manufacturing has become one of the main manufacturing paradigms in the 21st century. Under the networked manufacturing environment, there exist a large number of cooperative tasks susceptible to alterations, conflicts caused by resources and problems of cost and quality. This increases the complexity of administration. Process management is a technology used to design, enact, control, and analyze networked manufacturing processes. It supports efficient execution, effective management, conflict resolution, cost containment and quality control. In this paper we propose an integrated process management system for networked manufacturing. Requirements of process management are analyzed and architecture of the system is presented. And a process model considering process cost and quality is developed. Finally a case study is provided to explain how the system runs efficiently.

78 FR 9046 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Ammonium Sulfate..., go to www.regulations.gov . Title: NSPS for Ammonium Sulfate Manufacturing Plants (Renewal). ICR... operator of ammonium sulfate manufacturing plants. Estimated Number of Respondents: 2. Frequency of...

75 FR 20838 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-21

... Collection Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Wood Furniture... electronic docket, go to http://www.regulations.gov . Title: NESHAP for Wood Furniture Manufacturing.... Respondents/Affected Entities: Wood furniture manufacturing operations. Estimated Number of Respondents: 750...

77 FR 37900 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-25

... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Semiconductor...: NESHAP for Semiconductor Manufacturing (Renewal). ICR Numbers: EPA ICR Number 2042.05, OMB Control Number... the owners or operators of semiconductor manufacturing plants. Estimated Number of Respondents: 1...

76 FR 61342 - Foreign-Trade Zone 72 Temporary/Interim Manufacturing Authority Brevini Wind USA, Inc., (Wind...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Docket T-3-2011] Foreign-Trade Zone 72 Temporary/Interim Manufacturing Authority Brevini Wind USA, Inc., (Wind Turbine Gear Boxes); Notice of Approval On... manufacturing (T/IM) authority, on behalf of Brevini Wind USA, Inc., to manufacture wind turbine gear boxes...

40 CFR 1065.12 - Approval of alternate procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... POLLUTION CONTROLS ENGINE-TESTING PROCEDURES Applicability and General Provisions § 1065.12 Approval of... individual engine manufacturer may request to use an alternate procedure. This also means that an instrument... allow. (2) The degree to which the alternate procedure affects your ability to show that your engines...

78 FR 52087 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Disapproval of PM2.5

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

...] Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Disapproval of PM 2.5 Permitting...: EPA published a final rule in the Federal Register on July 25, 2013, disapproving a Wisconsin State... document on July 25, 2013, (78 FR 44881) disapproving revisions to Wisconsin rules NR 400, 404, 405, 406...

Impact of blood manufacturing and donor characteristics on membrane water permeability and in vitro quality parameters during hypothermic storage of red blood cells.

PubMed

Alshalani, Abdulrahman; Howell, Anita; Acker, Jason P

2018-02-01

Several factors have been proposed to influence the red blood cell storage lesion including storage duration, blood component manufacturing methodology, and donor characteristics [1,18]. The objectives of this study were to determine the impact of manufacturing method and donor characteristics on water permeability and membrane quality parameters. Red blood cell units were obtained from volunteer blood donors and grouped according to the manufacturing method and donor characteristics of sex and age. Membrane water permeability and membrane quality parameters, including deformability, hemolysis, osmotic fragility, hematologic indices, supernatant potassium, and supernatant sodium, were determined on day 5 ± 2, day 21, and day 42. Regression analysis was applied to evaluate the contribution of storage duration, manufacturing method, and donor characteristics on storage lesion. This study found that units processed using a whole blood filtration manufacturing method exhibited significantly higher membrane water permeability throughout storage compared to units manufactured using red cell filtration. Additionally, significant differences in hemolysis, supernatant potassium, and supernatant sodium were seen between manufacturing methods, however there were no significance differences between donor age and sex groups. Findings of this study suggest that the membrane-related storage lesion is initiated prior to the first day of storage with contributions by both blood manufacturing process and donor variability. The findings of this work highlight the importance of characterizing membrane water permeability during storage as it can be a predictor of the biophysical and chemical changes that affect the quality of stored red blood cells during hypothermic storage. Copyright © 2017 Elsevier Inc. All rights reserved.

Quality Tools and TRIZ Based Quality Improvement Case Study at PT ‘X’ A Plastic Moulding Manufacturing Industry

NASA Astrophysics Data System (ADS)

Wirawan, Christina; Chandra, Fory

2016-02-01

Theory of Inventive Problem Solving (TRIZ) is a creative encouraging problem solving method. TRIZ is prepared by Altshuller for product design. Altshuller prepared contradiction matrix and suggestion to solve contradictions usually occur in product design. This paper try to combine TRIZ with quality tools such as Pareto and Fault Tree Analysis (FTA) to solve contradiction in quality improvement problem, neither than product design problem. Pareto used to identify defect priority, FTA used to analysis and identify root cause of defect. When there is contradiction in solving defect causes, TRIZ used to find creative problem solving. As a case study, PT ’X’, a plastic molding manufacturing industry was taken. PT ‘X’ using traditional press machine to produce plastic thread cone. There are 5 defect types that might occur in plastic thread cone production, incomplete form, dirty, mottle, excessive form, rugged. Research about quality improvement effort using DMAIC at PT ‘X’ have been done by Fory Candra. From this research, defect types, priority, root cause from FTA, recommendation from FMEA. In this research, from FTA reviewed, contradictions found among causes troublesome quality improvement efforts. TRIZ used to solve the contradictions and quality improvement effort can be made effectively.

A new chapter in pharmaceutical manufacturing: 3D-printed drug products.

PubMed

Norman, James; Madurawe, Rapti D; Moore, Christine M V; Khan, Mansoor A; Khairuzzaman, Akm

2017-01-01

FDA recently approved a 3D-printed drug product in August 2015, which is indicative of a new chapter for pharmaceutical manufacturing. This review article summarizes progress with 3D printed drug products and discusses process development for solid oral dosage forms. 3D printing is a layer-by-layer process capable of producing 3D drug products from digital designs. Traditional pharmaceutical processes, such as tablet compression, have been used for decades with established regulatory pathways. These processes are well understood, but antiquated in terms of process capability and manufacturing flexibility. 3D printing, as a platform technology, has competitive advantages for complex products, personalized products, and products made on-demand. These advantages create opportunities for improving the safety, efficacy, and accessibility of medicines. Although 3D printing differs from traditional manufacturing processes for solid oral dosage forms, risk-based process development is feasible. This review highlights how product and process understanding can facilitate the development of a control strategy for different 3D printing methods. Overall, the authors believe that the recent approval of a 3D printed drug product will stimulate continual innovation in pharmaceutical manufacturing technology. FDA encourages the development of advanced manufacturing technologies, including 3D-printing, using science- and risk-based approaches. Published by Elsevier B.V.

California State Implementation Plan; Final Approval of Revision; Yolo-Solano Air Quality Management District; Reasonably Available Control Technology Requirements for 1997 8-hour Ozone NAAQS

EPA Pesticide Factsheets

EPA is taking final action to approve a revision to the Yolo-Solano Air Quality Management District (YSAQMD) portion of the California SIP concerning YSAQMD regarding RACT)requirements the 1997 8-hour ozone NAAQS and approve negative declarations into SIP.

Transformation in the pharmaceutical industry: transformation-induced quality risks--a survey.

PubMed

Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J; Mouzughi, Yusra

2013-01-01

This paper is the fourth in a series that explores ongoing transformation in the pharmaceutical industry and its impact on pharmaceutical quality from the perspective of risk identification. The aim of this paper is to validate proposed quality risks through elicitation of expert opinion and define the resultant quality risk model. Expert opinion was obtained using a questionnaire-based survey with participants with recognized expertise in pharmaceutical regulation, product lifecycle, or technology. The results of the survey validate the theoretical and operational evidence in support of the four main pharmaceutical transformation triggers previously identified. The quality risk model resulting from the survey indicated a firm relationship between the pharmaceutical quality risks and regulatory compliance outcomes during the marketing approval and post-marketing phases of the product lifecycle and a weaker relationship during the pre-market evaluation phase. In this paper through conduct of an expert opinion survey the proposed quality risks carried forward from an earlier part of the research are validated and resultant quality risk model is defined. The survey results validate the theoretical and operational evidence previously identified. The quality risk model indicates that transformation-related risks have a larger regulatory compliance impact during product approval, manufacturing, distribution, and commercial use than during the development phase.

77 FR 23652 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Leisure Properties LLC/D...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-20

... Promulgation of Air Quality Implementation Plans; Illinois; Leisure Properties LLC/D/B/A Crownline Boats... Properties LLC/D/B/A Crownline Boats (Crownline) at its West Frankfort, Illinois facility. On June 10, 2011... to emissions of volatile organic matter (VOM) from Crownline's manufacturing facility. The adjusted...

10 CFR 32.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 32.8 Section 32.8 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER...) The Nuclear Regulatory Commission has submitted the information collection requirements contained in...

10 CFR 32.8 - Information collection requirements: OMB approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 32.8 Section 32.8 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER...) The Nuclear Regulatory Commission has submitted the information collection requirements contained in...

Manufacturing Aids

NASA Astrophysics Data System (ADS)

1983-01-01

Contractor's work for Lewis Research Center on "thermal barrier" coatings designed to improve aircraft engine efficiency resulted in two related but separate spinoffs. The Materials and Manufacturing Technology Center of TRW, Inc. invented a robotic system for applying the coating, and in the course of that research found it necessary to develop a new, extremely accurate type of optical gage that offers multiple improvements in controlling the quality of certain manufactured parts.

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

PubMed Central

Tu, Pei-Weng; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

PubMed

Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

Manufacturing Process Applications Team (MATeam)

NASA Technical Reports Server (NTRS)

1978-01-01

The activities of the Manufacturing Process Applications Team concerning the promotion of joint Industry/Federal Agency/NASA funded research and technology operating plan (RTOP) programs are reported. Direct transfers occurred in cutting tools, laser wire stripping, soldering, and portable X-ray unit technology. TROP program funding approval was obtained for the further development of the cutting tool Sialon and development of an automated nondestructive fracture toughness testing system.

Quality by design approach: application of artificial intelligence techniques of tablets manufactured by direct compression.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Ozer, Ozgen; Güneri, Tamer; York, Peter

2012-12-01

The publication of the International Conference of Harmonization (ICH) Q8, Q9, and Q10 guidelines paved the way for the standardization of quality after the Food and Drug Administration issued current Good Manufacturing Practices guidelines in 2003. "Quality by Design", mentioned in the ICH Q8 guideline, offers a better scientific understanding of critical process and product qualities using knowledge obtained during the life cycle of a product. In this scope, the "knowledge space" is a summary of all process knowledge obtained during product development, and the "design space" is the area in which a product can be manufactured within acceptable limits. To create the spaces, artificial neural networks (ANNs) can be used to emphasize the multidimensional interactions of input variables and to closely bind these variables to a design space. This helps guide the experimental design process to include interactions among the input variables, along with modeling and optimization of pharmaceutical formulations. The objective of this study was to develop an integrated multivariate approach to obtain a quality product based on an understanding of the cause-effect relationships between formulation ingredients and product properties with ANNs and genetic programming on the ramipril tablets prepared by the direct compression method. In this study, the data are generated through the systematic application of the design of experiments (DoE) principles and optimization studies using artificial neural networks and neurofuzzy logic programs.

The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage.

PubMed

Panzitta, Michele; Ponti, Mauro; Bruno, Giorgio; Cois, Giancarlo; D'Arpino, Alessandro; Minghetti, Paola; Mendicino, Francesca Romana; Perioli, Luana; Ricci, Maurizio

2017-01-10

Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain. Manufacturing Technology should be acknowledged as a R&D step and as a very important matter during University degree in Pharmacy and related disciplines, promoting collaboration between Academia and Industry, measured during HTA step and rewarded in terms of price and reimbursement. The above elements are not yet properly recognised, and manufacturing technology is taken in to consideration only when a shortage is in place. In a previous work, Panzitta et al. proposed to perform a full technology assessment at the Health Technological Assessment stage, evaluating three main technical aspects of a medicine: manufacturing process, physicochemical properties, and formulation characteristics. In this paper, we develop the concept of manufacturing appraisal, providing a technical overview of upcoming challenges, a risk based approach and an economic picture of shortage costs. We develop also an overall quality concept, not limited to GMP factors but broaden to all elements leading to a robust supply and promoting technical innovation. Copyright © 2016 Elsevier B.V. All rights reserved.

30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

The reliability-quality relationship for quality systems and quality risk management.

PubMed

Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M

2012-01-01

Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality

75 FR 17711 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-07

... Approval; Comment Request; NSPS for Ammonium Sulfate Manufacturing Plants (Renewal) AGENCY: Environmental... information about the electronic docket, go to http://www.regulations.gov . Title: NSPS for Ammonium Sulfate... (NSPS) for Ammonium Sulfate Manufacturing Plants (40 CFR part 60, subpart PP), were proposed on February...

76 FR 80927 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Glass Manufacturing Plants... information about the electronic docket, go to http://www.regulations.gov . Title: NESHAP for Glass... New Source Performance Standards (NSPS) for Glass Manufacturing Plants (40 CFR part 60, subpart CC...

78 FR 36772 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Lead-Acid Battery... the electronic docket, go to www.regulations.gov . Title: NSPS for Lead-Acid Battery Manufacturing...: Owners or operators of lead-acid battery manufacturing facilities. Estimated Number of Respondents: 52...

78 FR 38256 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

...EPA is issuing a supplement to its proposed approval of Ohio's request to redesignate the Ohio portion of the Parkersburg-Marietta, West Virginia-Ohio, area to attainment for the 1997 annual National Ambient Air Quality Standards (NAAQS or standard) for fine particulate matter (PM2.5). This supplemental proposal revises and expands the basis for proposing approval of the state's request, in light of developments since EPA issued its initial proposal on November 30, 2012. This supplemental proposal addresses the effects of a January 4, 2013, decision of the United States Court of Appeals for the District of Columbia (D.C. Circuit or Court) to remand to EPA two final rules implementing the 1997 PM2.5 standard. In this supplemental proposal, EPA is also proposing to approve a supplement to the emission inventories previously submitted by Ohio. EPA is proposing that the inventories for ammonia and volatile organic compounds (VOC), in conjunction with the inventories for nitrogen oxides (NOX), direct PM2.5, and sulfur dioxide (SO2) that EPA previously proposed to approve, meet the comprehensive emissions inventory requirements of the Clean Air Act (CAA or Act). EPA is seeking comment only on the issues raised in its supplemental proposal, and is not re-opening for comment other issues raised in its prior proposal.

77 FR 6743 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

...EPA is proposing to approve a request from Illinois to redesignate the Illinois portion of the Chicago-Gary-Lake County, Illinois-Indiana (IL-IN) ozone nonattainment area (the Greater Chicago area) to attainment of the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS or standard) because the request meets the statutory requirements for redesignation under the Clean Air Act (CAA). The Illinois portion of the Greater Chicago area includes Cook, DuPage, Kane, Lake, McHenry, and Will Counties and portions of Grundy (Aux Sable and Goose Lake Townships) and Kendall (Oswego Township) Counties. The Illinois Environmental Protection Agency (IEPA) submitted this request on July 23, 2009, and supplemented its request in a submittal on September 16, 2011. EPA is proposing to approve, as a revision of the Illinois State Implementation Plan (SIP), the State's plan for maintaining the 1997 8-hour ozone standard through 2025 in the Illinois portion of the Greater Chicago area. EPA is proposing to approve 2002 Volatile Organic Compound (VOC) and Nitrogen Oxides (NOX) emission inventories for the Illinois portion of the Greater Chicago area as a revision of the Illinois SIP because the emission inventories meet the requirements of section 182(a) of the CAA. Finally, EPA proposes to approve the State's 2008 and 2025 VOC and NOX Motor Vehicle Emission Budgets (MVEBs) for the Illinois portion of the Greater Chicago area.

78 FR 26255 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Approval of Texas Low...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-06

...EPA is granting direct final approval of a revision to the Texas State Implementation Plan (SIP) concerning the Texas Low Emission Diesel fuel rules. The revisions clarify existing definitions and provisions, revise the approval procedures for alternative diesel fuel formulations, add new registration requirements, and update the rule to reflect the current program status because the rule is now fully implemented. This SIP revision meets statutory requirements.

78 FR 26301 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Approval of Texas Low...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-06

...EPA is proposing approval of a revision to the Texas State Implementation Plan (SIP) concerning the Texas Low Emission Diesel (TxLED) Fuel rules. The revisions clarify existing definitions and provisions, revise the approval procedures for alternative diesel fuel formulations, add new registration requirements, and update the rule to reflect the current program status because the rule is now fully implemented. This SIP revision meets statutory requirements.

46 CFR 160.053-4 - Inspections and tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-4 Inspections and.... (b) Manufacturer's inspections and tests. Manufacturers of approved work vests shall maintain quality... samples from each lot to maintain the quality of their product. (c) Lot size. A lot shall consist of not...

46 CFR 160.053-4 - Inspections and tests.