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Labcompliance News, December 1999

December 20, 1999

Free Validation Master Plan

Validation master plans are not specifically required by the FDA. However, the FDA wants to know your approach towards validation. A master plan is the ideal tool. You can get a free Equipment Validation Master Plan when you purchase any of Ludwig Huber's Validation Reference Books until the end of January 2000. The master plan is both concise and comprehensive. Whether you use it as it is or as a template: it saves time and increases confidence for inspections.

December 15, 1999

New ICH documents published on the EMEA web site.

There are a number of new ICH documents on the EMEA web site
CPMP/ICH/2887/99 (Topic M4, Step 2) Common Technical Document: Module V Efficacy, Module III Quality, Modules IIA, IIB and IV Safety (released for consultation Nov. 99)
CPMP/ICH/2736/99 (Topic Q1A, Step 2) Note for Guidance on Stability Testing of New Drug Substances and Products (Revision of CPMP/ICH/380/95, released for consultation Nov. 99)
CPMP/ICH/2737/99 (Topic Q3A, Step 2) Note for Guidance on Impurities Testing: Impurities in New Drug Substances (Revision of CPMP/ICH/142/95, released for consultation Nov. 99)
CPMP/ICH/2738/99 (Topic Q3B, Step 2) Note for Guidance on Impurities in New Drug Products (Revision of CPMP/ICH/282/95, released for consultation Nov. 99) CPMP/ICH/365/96 Note For Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Adopted March 99)

These documents are intended to be identical to the ones on the same topics which are to be released in the US and Japan under the ICH procedure.

December 15, 1999

Part 11 FDA Industry Training - Video Available

On Oct 21, 1999, the FDA conducted a video training for the industry on 21 CFR Part 11. For those who could not attend a video of the training as available.

December 1, 1999

New Publication: 21 CFR Part 11: Security Aspects

The 2nd article of this series explains the practical and technical implications of "Part 11" with respect to access security, user rights and audit trail in data systems that are used in the analytical laboratories. Access security mechanisms are required to prevent unauthorized persons to access, alter or delete records in a system. Access security is typically ensured by a number of behavioral controls or policies that are backed up and enforced by appropriate security mechanisms implemented on a company’s information systems. The article covers the relevance of appropriate security settings such as security and password policies on laboratory computers and how today’s chromatographic data systems do or do not make use of them. If not well designed, the effort in maintaining the security model of the operating system may be replicated in each application.
Download draft version from LabCompliance User Club.

December 1, 1999

ICH Criteria for Biotechnology Products

ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products - 8/18/99 - (PDF), (Text)