China Initiates Foreign GMP Inspections

China’s State Food and Drug Administration (SFDA) is planning to start a new drug GMP inspection program. Under the pilot program, officials from SFDA’s GMP department will visit a total of 10 overseas manufacturing facilities, concentrating on vaccines, biologics, and active pharmaceutical ingredients.

The program is part of the Chinese SFDA’s ongoing efforts to strength its GMP regulations and to align its GMP practices with international standards. In 2010, SFDA revised the Measures for Drug GMP Certification and set new requirements for appointing and evaluating drug GMP inspectors. It has also set down new contract-manufacturing requirements and standardized its inspection and certification procedures.

Under SFDA’s new GMP regulations, existing drug manufacturing facilities have until a 2015 or 2016 deadline, depending on the type of product produced, to apply to the new standards.

For more information regarding the revised drug GMP regulations released in March, 2011, please see PBM’s eNewsletters or publications.