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Labcompliance News, September 2003

September 26, 2003

Reconfirmed: GMP Training Records don't need to Comply with Part 11

At the a Life Video Conference on the New Scope of Part 11 FDA officials have been asked for examples where part 11 does not apply. The question has been answered by Scott MacIntire, Director of the Division of Compliance Information and Quality Assurance of ORA and Joseph Famulare, Director of the Division of Manufacturing and Product Quality, CDER Office of Compliance. After many discussions at conferences and in discussion groups, an FDA official has been asked again and he reconfirmed his statement. 

September 16, 2003

PIC/S Releases Final Guide on Computer Systems in GxP Environments

On August 20, 2003, the Pharmaceutical Inspection convention (PIC/S) has released the final guidance document: Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-1). The purpose of the document is to provide recommendations and background information that will be of assistance to inspectors and during GxP inspections of computerized systems. Information on 55 pages is quite detailed. The recommends L.Huber's Book on Validation of Computerized Analytical Systems for further reading. It is the only one on the list dedicated to laboratories and in the meantime has been updated. for more information and ordering the book, click here.

September 8, 2003

FDA Changes the Compliance Program Guide for Pre-Approval Inspections

The Implementation portion of Compliance program guide (CPGM) 7346.832 has been updated to incorporate a risk based approach consistent with the Agency's GMPs for the 21st Century Initiative in order to help reduce the number of pre-approval inspections and leverage pre-approval resources, where practical, for post approval and/or CGMP coverage. The FDA felt that these changes are needed to allow greater use of risk-based decisions in the assignment and conduct of pre-approval inspections

The strategy for assigning PAIs now includes two general categories, those that will regularly prompt an inspection request from CDER and categories where the district office may choose to perform an inspection. This revised inspection strategy provides ORA Field Offices greater flexibility in determining if a pre-approval inspection is necessary based on the most current knowledge and cGMP status of a firm. Additional changes include the deletion of the inspection categories for narrow therapeutic range drugs and generic versions of the top 200 most-prescribed drugs. These changes are effective immediately and have been incorporated into Compliance Program 7346.832

Labcompliance has developed a Best Practices reference book to better understand and prepare for FDA inspections. The book takes into account FDA's new approach for risk based system inspections.

September 8, 2003

FDA Issues Draft Guidance on Voluntary Process Analytical Technology

The draft guidance PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance is intended to describe a regulatory framework that should encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance technologies. It should help pharmaceutical manufacturers design, develop, and implement new efficient tools for use during product manufacture and quality assurance while maintaining or improving the current level of product quality assurance. It was developed through a collaborative effort involving CDER, the Center for Veterinary Medicine (CVM), and Office of Regulatory Affairs (ORA). The has two components: (1) a set of scientific principles and tools supporting innovation and (2) a strategy for regulatory implementation that will accommodate innovation. Among other things, the regulatory implementation strategy includes creation of a PAT Team approach to CMC review and CGMP inspections and joint training and certification of PAT review and inspection staff.

September 8, 2003

FDA's Progress Toward "21st Century" Regulation of Pharmaceutical Manufacturing

The Food and Drug Administration reported on the progress and outlined new steps in its strategic initiative to modernize the regulation of pharmaceutical manufacturing and product quality. Achievements and news steps include
First, the agency issued five new guidances designed to enhance the consistency and coordination of its drug quality regulatory programs
Second, the agency has collaborated with academia, industry and other government organizations to promote innovative approaches to drug development and regulation
Third, FDA has taken steps to streamline and improve its internal processes

September 3,2003

FDA Releases Final Part 11 Guidance on Scope and Applications

On September 3rd the FDA released it's long awaited final version of the part 11 guidance on scope and applications. The guidance states that the FDA is re-examining part 11 and anticipates initiating rulemaking to change part 11 as a result of that re-examination. It also states that the FDA does not intend to re-issue part 11 draft guidances as withdrawn in February 2003 but references existing FDA guidance documents on software and computerized systems. As expected by Labcompliance (see News from July) the final release is not much different from the draft. It is a more specific in some areas, e.g., related to legacy systems, but by no means as specific as suggested by some of the industry comments. In light of this the paper as published by BioPharm in May this year on implementing the new part 11 guidance is still up-to-date. To order a free copy, click here. The guidance reiterates the importance of implementing critical requirements based on 'justified and documented' risk assessment. An SOP and and a Risk Management Masterplan to address this are available from Labcompliance.