In order to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the tenth experts’ forum on October 19. At this forum, Dr. -Ing.Stephan RÖnninger and Dinesh Khokal from Amgen, were invited to give a lecture on “GMP for APIs – ICH Q7 and Quality Risk Management (ICH Q9)”.

On the basis of introducing the scope, definitions and applicability of GMP for APIs – ICH Q7, Dr. RÖnninger explained in detail the biological API, distribution and other contents of the Q7 guideline, and elaborated the quality risk management process and regulatory guidance of the Q9 guideline. Dr. Khokal elaborated the quality system elements and API production contents of ICH Q7 guidelines from the specific chapters of quality management, staff, personnel, buildings and facilities. The lectures of the two experts improved the participants' understanding of ICH Q7 and Q9 guidelines, deepened the inspectors' understanding of the supervision of API production, and enhanced the inspectors' awareness of quality risk management.

The Office of Drug Supervision, the Chinese Pharmacopoeia Commission, CFDI, the Center of Beijing Drug Certification, the Center of Beijing Drug Review, and 21 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally more than 300 person participated in the training.