Rx-360 Summary ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A

The ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for active pharmaceutical ingredients (APIs) (dated 10 June 2015) reached Step 4 of the ICH Process in June 2015 and now enters the implementation period (Step 5). ICH made the Q&A document available on 19 June 2015.

Experience gained with the implementation of the ICH Q7 Guideline since its finalization in 2000 shows that uncertainties related to the interpretation of some sections existed. 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 harmonize expectations during inspections, to remove ambiguities and uncertainties and also to harmonize the inspections of both small molecules and biotech APIs.  Note that Q&As have been developed for all sections of ICH Q7.

To view or download the ICH Q7 Q&A, click here