News about GMP/cGMP


FDA Finalises ICH Q7 "Q&A on GMPs for APIs"

The FDA (US Food and Drug Administration) finalised the ICH Q7 Q&A Guidance on GMPs for APIs on Thursday April 19, 2018.

The finalisation of the 24-page guidance follows its endorsement by the regulatory agencies participating in the ICH in June 2015 and features questions and answers on quality management, personnel, buildings and facilities, process equipment, documentation and records, storage and distribution, among other topics.


FDA Guidance for Industry: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Q&A