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Labcompliance News, September 2000

Sept 18, 2000

GAMP Releases Part 11 Draft Guidelines and Expands to America

The Good Automated Manufacturing Practices (GAMP) Forum exists to promote the understanding of the regulation and use of computer and control systems within the pharmaceutical manufacturing industry. The forum has done an excellent job on developing industry guidelines for software and computer validation. These guidelines have been successfully used throughout the world in preparation for US FDA and European regulatory inspections and for vendor audits. Now this forum has developed draft guidelines on how to implement FDA's 21 CFR Part 11 on e-records&signatures and the forum expands its activities to North America. The first meeting has been held on Sept 12, 2000. .

September 18, 2000

Is the Scope of Part 11 Changing?

We always have been told that FDA's 21 CFR Part 11 on electronic records and signatures applies when three criteria apply: 1) the work is done in an FDA regulated environment, 2) computers are used to create, evaluate, maintain, archive and transmit data and 3) records are saved to a durable storage device. There seems to be change to #3 to "records saved to tangible media and retrievable for re-evaluation". This would be more in line with the US E-sign Act from Nov 9, 1999. This change has been indicated by FDA's Paul Motise several times and reflects technological changes. Tangible media also include modern storage devices like flash discs. The impact for the pharmaceutical industry and on pharmaceutical analytical laboratories will be discussed on Oct 5/6, 2000 in Copenhagen at the conference: FDA 21 CFR Part 11 Compliant Electronic Signatures and Records in Pharmaceutical Laboratories in Copenhagen and in IVT's conference on e-records and signatures in Dublin, Ireland.

September 17, 2000

Keynote Address at the annual IDMA convention: Recent Developments and Trends in US FDA and International GLP/GMP and other Regulations

 Dr. Ludwig Huber from Agilent Technologies presented this presentation as keynote address at the annual convention of the Indian Drug Manufacturer Association (IDMA). The presentation started with mega trends, international harmonization efforts through the ICH and OECD and new contents of the updated US cGMP regulations. After that Ludwig Huber went into details about contents, consequences and inspection and enforcement practices of the US FDA draft guidelines on Handling Out of Specification situations (OOS) and FDA's 21 CFR Part 11 on Electronic Records and Signatures. At this convention Ludwig Huber also received the International GLP Award for his excellent work on validation and GLP/GMP compliance.