Chinese GMP: Inspection Standard Checklist

In the Chinese regulatory system for pharmaceutical products, companies are issued certificates that show them to be GMP compliant. To receive such a certificate, a company must pass an inspection based on the current GMP regulations. This inspection is carried out against an official inspection checklist that is derived from the Chinese GMP regulations. In this supplement to their translation of the "Chinese Drug GMP" Li and Kuwahara have translated and annotated the most recent edition of this checklist. This new version of the checklist was issued by the Chinese State Food and Drug Administration as a part of their effort to increase the stringency of their GMP inspections. Since January 1, 2008, Chinese GMP inspections have been conducted by using this checklist, and the criteria for awarding a GMP certificate have been tightened.