WHO TRS (Technical Report Series) 908, 2003 Annex 5

Model certificate of Good Manufacturing Practices

A model certificate of Good Manufacturing Practices (GMP) for a manufacturing site is suggested (see below). This is not part of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce but is intended to serve in situations where a specific GMP certificate is requested by importers, exporters, procurement agencies and regulatory authorities. It is suggested that the certificate should remain valid for a period of 2 years from the date of issue, but not exceeding 3 years after the inspection was carried out. 

It is recommended that, where possible, GMP certificates should have, e.g. security seals, watermarks or holograms, to help prevent counterfeiting, tampering and other fraudulent activities.

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WHO TRS (Technical Report Series) 908, 2003 Annex 5: