Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.”The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. Since the ICH Q7 Guidance was finalized, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the interpretation of certain sections. This question and answer (Q&A) document is intended to respond to those requests. More information is available on the FDA’s website.