The ICH Q7 "How to do Document" was developed by APIC, a sector group of the European Chemical Industry Council (CEFIC). CEFIC represents all major chemical industry companies in Europe. The paper interprets the ICH Q7 Guide’s GMP requirements manufacturers of active ingredients have to fulfil.
The Guide does not create a manual for accomplishing a 100% GMP compliance. Much rather it intends to support API producing sites with a guide comprising practical examples and recommendations for solving problems for which the ICH Q7 Guide does not provide concrete answers. Francois Vandeweyer, Director Global Compliance at Janssen Pharmaceutica, Belgium and Vice Chair of the GMP and Quality Assurance Working Group within APIC gave a presentation about the new Version 6 of the How to do Guide at the European API Conference on 27 - 29 October 2010 in Barcelona.
You can order a copy of the ICH Q7 "How to do Guide".
ECA and APIC are jointly organising the ICH Q7 week in Barcelona. The programme is available at www.ichq7-week.org.