Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

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.

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers.Guidance for Industry