Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH has issued a final version of its questions and answers relating to ICH Q7. According to ICH:

“The Guideline reached Step 4 of the ICH process on June 2015. 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.”

To access the document, go to: ICH.

Posted by Tim Sandle