Wednesday, 5 September 2018

FDA - Guidance for Active Pharmaceutical Ingredients


The FDA recently released a new set of questions and answers for its guidance, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. 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. The question and answer (Q&A) document is intended to respond to those requests.

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.

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM605076.pdf

Posted by Dr. Tim Sandle

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