Notice on the Adoption of the PIC/S Guide to GMP

Administrative Order (AO) No. 2012-008, or the rules on the “Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guide for Good Manufacturing Practice (GMP) for Medicinal Products”, directs all drug establishments to adopt the current version of PIC/S GMP Guide as the standard for Good Manufacturing Practice.

 

The AO likewise orders that all supplements and revisions related to the PIC/S GMP Guides shall be adopted automatically.

 

Notwithstanding, it is reiterated that the version of the PIC/S Guide to GMP being implemented at this juncture is PE009-13, which took effect on 1 January 2017, until further notice from FDA.

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