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Wednesday, August 28, 2013

21 CFR Part 11

New EU GMP Guide Annex 11 "Computerised Systems"  & Chapter 4 "Documentation" 

In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for GMP regarding IT systems in the pharmaceutical industry. The new version was issued on 3 January 2011 together with the EU GMP Guide Chapter 4 "Documentation". It will become effective on 30 June 2011.
Reasons for changes: the Annex has been revised in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide.
Deadline for coming into operation: 30 June 2011

Reasons for changes: the sections on "generation and control of documentation" and "retention of documents" have been revised, in the light of the increasing use of electronic documents within the GMP environment.
Deadline for coming into operation: 30 June 2011

The PIC/S Guide to Good Manufacturing Practices is the basis for GMP inspections. In particular its Annex 11, ‘Computerised Systems’ is used when inspecting such systems. 

Guidance document on part 11-Electronic signature & Electronic record & Computer System Validation(CSV)
NEW: Annex 1: Validation of computerised calculation systems: example of validation of in-house software - Spread sheet/Microsoft Excel
NEW: Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN)
NEW: Annex 3: Validation of computers as part of test equipment
GAMP 4 to GAMP 5 -Summary

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