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Labcompliance News, August 2001

Aug 14, 2001

Canada Issues Drug Validation Guidance

The new guidance from Health Canada deals with validation requirements of Canada’s good manufacturing practices and describes what Health Canada expects from domestic as well as foreign drug companies to meet GMP validation practices.

Aug 6, 2001

Update from FDA's McCormack on Part 11

At a Drug Information Assn (DIA) meeting in Washington on May 21 James McCormack from the US FDA gave an update on part 11. He talked about FDA's recent enforcement practices and gave a list of most 44 frequently found deviations from 26 warning letters: access security (13) audit trail (13)and validation (12). He also talked about topics and rollout of FDA's long awaited part 11 guidance documents. The first six will include a glossary and deal with validation, time stamps, archiving, e-copies of e-records and with audit trail. More details on contents of the guidance documents can be found in the presentation. User club members can download the presentation, for preview and ordering users club membership, click here

Aug 6, 2001

FDA Guide for Validation of Biological Incubator Incubation Time

The old "FDA Guide for validation of Biological Indicator Incubation Time" from 1986 was formerly available from the index of www.fda.gov/cdrh. This document will be replaced by Appendix H of the FDA Guidance for Industry and FDA Reviewers on "Biological indicators intended to monitor sterilizers used in health care facilities: FDA Guidance for validation of Biological Incubation Time".