19 June 2015

The ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients reached Step 4 of the ICH Process in June 2015 and now enters the implementation period (Step 5).

Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 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 - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.

The final Guideline is now available for download under the Quality Guideline page.

The direct link to the Q7 Q&As document is here