An NSF International Company ICH Q7 Implementation Working Group
Wednesday the 5th December 2012
At their last meeting the ICH Steering Committee approved a Concept Paper that recommended the setting up of an Implementation Working Group (IWG) to produce a Q&A document for Q7, the GMPs for APIs.
The need for this IWG was based on experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000, which shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines (Q8, 9, 10 & 11) - will be addressed in this Question and Answer document in order to harmonize expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.
A copy of the Concept Paper is attached.
