China’s State Food and Drug Administration (SFDA) published the revised Health Food GMP on 30 September 2011. SFDA has adopted a new philosophy on GMP compliance, which emphasizes the applicable practices rather than using the stipulated technical standards as in the 1998 version.
The new version significantly heightened the requirements such as validation and control of ingredients, control of equipment and document, and cleanroom environment.
GMP 2011 contains nine chapters including General Provision, Organization and Personnel, Building and Premises, Equipment, Material and Finished Product, Production Control, Quality Control, Document Control and Definitions. There are 128 requirements stipulated in these nine chapters.
Lam Keng Siak, a Singapore-based independent GMP consultant, offers an English translation of the news regulations. Please contact him at [email protected] for more information.