Adoption and Implementation of the World Health Organization Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products, and Annex 9 Guide to Good Storage Practices for Pharmaceuticals

In order to maintain the original quality of the product, every active in the distribution of pharmaceutical products should be carried out in the principles of Good Manufacturing Practice (GMP), Good Storage Practice (GSP) and Good Distribution Practice (GDP).

The Mutual Recognition Agreement (MRA) created by the ASEAN member States adopted the Pharmaceutical Inspectorate Cooperation Scheme - Good Manufacturing Practice (PIC/s-GMP) as a standard for inspection.  Originally, the PIC/s-GMP Guide was derived from the WHO-GMP Guide and was further developed in order to comply with stringent manufacturing and health requirements in PIC/S countries, to cover new areas (e.g. biologicals, radiopharmaceuticals, etc.) and to adapt to the changing scientific and industrial technology (e.g. biotech, parametic release etc.)  The aim of such improvements was to ensure that high quality medicines were produced in line with the PIC Convention and then the PIC Scheme.

 

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