FDA- Good Manufacturing Practice guidance for Active Pharmaceutical Ingredients

FDA- Good Manufacturing Practice guidance for Active Pharmaceutical Ingredients

The FDA has published a new set of questions and answers for its guidance. Since the ICH Q7 guidance was finalised, there were problems implementing the guidance worldwide which resulted in an increase of requests for clarification. This resulted in a Q&A document provided by the FDA.

See link: 

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