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Labcompliance News, November 2006

November 16, 2004

Current Status and Future Directions of Part 11

Joe Famulare, Director of the Division of Manufacturing and Product Quality, CDER Office of Compliance gave a presentation at the Joint PDA/FDA meeting on September 21 about Part 11. Most interesting was on outlook into the future Currently the FDA is requesting comments on the re-examination of Part 11 in areas where part 11 most likely will change: These are areas that could be less prescriptive and detailed, possible elimination of the distinction made between 'open' and 'closed' systems, possible additional requirements for investigation and follow up when security breaches occur, and risk mitigation for legacy systems. Famulare also gave specific information and examples of systems that are now outside of the scope of Part 11 and for changes of legacy systems that will not effect Part 11 legacy system status.

November 15, 2004

FDA Citations for Quality System Violations

Violations of the FDA's quality system regulation (QSR) are amongst the most frequently cited deviations of medical device manufacturering inspections. Quality systems are also always subject to drug CGMP nspections, in addition to one or more other manufacturing systems as defined in the FDA Compliance policy guide for drug GMP inspections. With the release of FDA's quality system guide for drug CGMPs we expect that FDA inspectors will pay an even closer look at quality systems in drug manufacturing and quality control laboratories. Therefore it is a good advice to pay attention to most frequently citations from inspections according to the of QS regulation.

November 15, 2004

FDA Answers Frequently Asked Questions About the 21st CGMP Initiative

As part of the cGMP initiative announced in August of 2002, and to help FDA be more transparent with cGMP policy, the FDA has developed a question and answer resource with guidance on Current Good Manufacturing Practices. The FDA intends to use the format to provide timely answers to questions about the meaning and application of cGMPs for human, animal, and biological drugs, and to share these widely. These questions and answers generally clarify statements of existing requirements or policy, and as such, are considered Level 2 guidance. Currently the resource has sections on: Organization and Personnel, Buildings and Facilities, Equipment, Control of Components and Drug Product Containers and Closures, Production and Process Controls, Packaging and Labeling Control, Holding and Distribution, Laboratory Controls, Records and Reports, Returned and Salvaged Drug Products. .

November 15, 2004

FDA Issues Final Report on Its “21 st Century” Initiative on the Regulation of Pharmaceutical Manufacturing

Following the second anniversary of the launch of its Pharmaceutical Manufacturing Initiative, the Food and Drug Administration (FDA) today issued a final report that highlights specific steps the agency has taken and will take to develop and implement quality systems management and a risk-based product quality regulatory system.

The report describes the accomplishments and plans for the future resulting from FDA’s completed assessment of the current good manufacturing practice (CGMP) regulations, current practices, and the new tools in manufacturing science that will enable a progression to controls based on quality systems and risk management. T

November 15, 2004

Links to 23 FDA 'Predicate Rules'

Predicate rules are the requirements that can be found in part 21 CFR Food and Drugs regulations. They are basically promulgated under the authority of the Food Drug and Cosmetic Act or under the authority of the Public Health Service Act. The most well-known FDA regulations are the GLP and GMP regulations but there are many more. All FDA regulations can be downloaded from the FDA website but sometimes they are not easy to find. Labcompliance has a new site with a list of and links to 23 FDA regulations.