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Labcompliance News, September 2006

September 1, 2006

Record Retention for Hybrid Systems

This discussion has been going on as long as computer systems have been used in FDA regulated laboratories. Records are generated with a computer, printed and signed and electronic records are deleted: Is this practice compliant wit FDA regulations. Part 11 did not really help to clarify and even not the Part 11 guidance "Scope and Applications". The guide has some general statements and always refers to predicate rules. The situation will go on especially since the FDA has "Electronic raw data not saved" cited in a recent warning letter. The answer depends on each individual situation: predicate rule requirements and how complete electronic records can be converted to paper. Attend the Labcompliance Audio Seminar to learn more about this.

September 1, 2006

IVT Conferences Come to Singapore

The Institute for Validation and Technology (IVT), a division of Advanstar communication is a leading publisher and conference provider for validation and compliance. While IVT conferences have been focusing in the past on North America and Europe, now the company is is expanding its offering to Asia. The first conference will take place in Singapore from October 3-5, 2006. It will be the Asian Validation and Compliance Summit. Targeted to (Bio)Pharmaceutical Manufacturing and Laboratory operations the conference will offer three parallel tracks for Validation, Laboratory Controls and Quality Systems. Attendees can design their own programs as the interactive sessions and workshops fit their needs. There is a high interest in this conference. "Early registrations indicate that this could become IVT's Event of the Year", said John Kirchner, president of IVT.

September 1, 2006

New FDA Industry Guidance: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols

The guidance has been announced on June 1, 2006. According to the FDA the guidance should assist manufacturers of biological products in submitting lot release protocols in electronic format to CBER’s Product Release Branch. The new guidance finalizes the draft guidance entitled “Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research”, dated May 1998. In a discussion section the FDA encourages electronic submission: "Regulatory submissions in electronic formats, consistent with lot release requirements applicable to your product, will facilitate our review of your submission, provided that you submit your data to us in an electronic format that we can readily access."