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Labcompliance News, April 1999

Apr 1, 1999

Article Series on Implementation of 21CFR part 11

A series of articles is being developed that will provide background information on 21 CFR 11 and an overall strategy with specific examples for analytical laboratories on how to implement the new rule most efficiently. There are still some discussions going on between the industry and the FDA about the details of specific issues like time stamped audit trails; global time vs. local time and archiving of intermediately obtained and re-evaluated final results. In light of this the first few articles may raise more questions than they can give answers. However, as time goes by, the articles will be more specific with detailed guidelines. All the findings are also being presented and discussed in conferences and industry meetings dedicated to this topic.
Download draft version of article #1 from LabCompliance User Club.

Apr 1, 1999

Mutual Recognition Agreement between the US and the EU

The March 9, 1999 issue of the Federal Register contained an announcement of Implementation of the Mutual Recognition Agreement between the United States and the European Community; Pharmaceutical GMP's and Medical Devices; Establishment of a Public Docket and FDA Contact Points.Download as txt or as pdf file


Apr 1, 1999

PhRMA Comments on Draft FDA Guidance: OOS results

Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production.
Comments are made on: who should/can do failure investigations, who can/should do retesting, OOS related to specifications versus trends, "aggregating additional data" versus "testing into compliance", outlier tests not only for biological assays.