In Europe, the implementation of GMP is laid down in Directive 2003/94 and in the EU GMP Guide (incl. Annexes). Annex 11 "Computerised Systems" was revised in January 2011 together with Chapter 4 of the EU GMP Guide. Both documents must be implemented by the pharmaceutical industry by 30 June 2011.
The EMA (European Medicines Agency) has just published answers to questions on computerised systems under "Q&A: Good Manufacturing Practices (GMP)".
Here are the main topics:
Please see the detailed questions and answers.
Dr Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)