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SFDA issues Requirements for the Certification of Good Manufacturing Practice



The State Food and Drug Administration (SFDA) issued on September 7, 2005 Requirements for the Certification of Good Manufacturing Practice, which will take effect on October 1, 2005 and its predecessor (Guo Yao Jian An [2002] No. 442) shall be abrogated simultaneously.

The newly released Requirements comprises seven chapters: General Provisions, Application and Review, On-site Inspection, Approval and Certificate Issuance, Follow-up Inspection, Inspector Management and Supplementary Provisions. The Requirements details  each step of the certification of Good Manufacturing Practice for pharmaceutical products.