Guideline for Suspension and Revocation of GMP Certification of Manufacturers

Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent GMP inspectors with requisite education and appointed by the NMRA. GMP is used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. The purpose of GMP inspection is to assess the GMP compliance status of a manufacturer. Upon compliance of a manufacturer to GMP standards GMP compliance certificate is issued. The compliance certification will remain in force for such a period as prescribed in the regulations. None the less if the conditions of issuance of the compliance certification changes then the issuing authority can suspend or revoke the compliance certificate. This guidance document spells out the procedure and conditions of suspension/revocation of GMP certificate. The guidance also provides for cancellation of suspension and revocation and provides steps taken to appeal the suspension/revocation.