FDA Finalizes ICH Q7 Questions and Answers on GMPs for APIs

Regulatory NewsRegulatory News | 19 April 2018 |  By 

The US Food and Drug Administration (FDA) on Thursday finalized the International Council for Harmonisation’s (ICH) Q7 question and answer guidance on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs).

The finalization of the 24-page guidance follows its endorsement by the regulatory agencies participating in 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.

“The ICH Q7 document should be read in its entirety regardless of the nature of the manufacturing activities being conducted to fully understand the linkages between certain sections and successfully implement appropriate good manufacturing practices (GMPs) at all stages of the active pharmaceutical ingredients (API) supply chain, including distribution,” the Q&A says.

The Q&A also notes that ICH Q7 should be applied in combination with the principles from development and manufacturing in ICH Q11, Quality Risk Management (ICH Q9), and Pharmaceutical Quality Systems (ICH Q10).

The finalization of the document follows Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in 2016 joining with FDA, the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of GMP inspections for sites producing APIs.

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


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy