GUIDELINE FOR GMP INSPECTIONS
Good Manufacturing Practice (GMP) is referred to as the minimum standards that must be fulfilled by the manufacturing facility to ensure consistent production of quality products. Pharmaceutical GMP Inspection is performed to assess compliance with the GMP requirements as set out in the currently applied guidelines. Section 52(c) of the ZFDC Act No. 2/2006, requires a pharmaceutical manufacturing facility to comply with the GMP for its products to be registered in Zanzibar. Pharmaceutical GMP Inspection is performed on both local and overseas pharmaceutical manufacturing facilities.
As a participating member of the East African Community Medicine Regulatory Harmonization Initiative (EAC-MRH), Zanzibar Food and Drug Agency (ZFDA) ensures effective utilization of the limited resources as well strengthening capacity of its regulatory workforce through knowledge sharing. The initiative harmonizes the medicine registration procedures for its member states including the area of GMP Inspection among others and provides for Community aligned guidelines and joint inspections. The guidance document is aimed to highlight the requirements for GMP and effective execution of Inspection whereas the joint inspections end with recommendation for granting a certificate of GMP Compliance by member states.
The current version of the guidance document released on April 2014 by the EAC-MRH was compiled by the East African Community (EAC) Technical Working Group (TWG) on GMP based on their experience and knowledge on pharmaceutical manufacturing including GMP requirements of their individual Countries, World Health Organization (WHO) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) and other available literature.
To ensure alignment with the EAC GMP guidelines, ZFDA hereby adopt the COMPENDIUM OF GOOD MANUFACTURING PRACTICES (GMP) TECHNICAL DOCUMENTS FOR HARMONIZATION OF MEDICINES REGULATION IN THE EAST AFRICAN COMMUNITY, 2014 to be utilized as a guidance document with regards to Pharmaceutical GMP and Pharmaceutical GMP Inspections performed by ZFDA. Moreover, ZFDA comprehends that the guidance is subjected to periodic revisions based on new available knowledge and experience. Hence, it is hereby acknowledged that ZFDA shall have a final decision on the utilization of revised versions of the guidance document at the time of their effective release.
The guideline is accessible through the provided link.