GMP Inspection of pharmaceutical manufacturing facilities is conducted to assess compliance with the requirements of Good Manufacturing Practice (GMP) as prescribed in the East African Community (EAC) GMP compendium for human medicines and the Good Manufacturing Practices Guidelines for Veterinary Medicinal Products manufacturing facilities.
The inspection aims to ensure that medicines that are manufactured by domestic facilities and those imported from other countries are of acceptable quality, safety and efficacy. According to Section 51 of the Tanzania Medicines and Medical Devices Act, Cap 219, registration is only granted to products that are manufactured by a GMP-compliant facility.
To effectively utilize the limited resources available, TMDA participate in joint GMP inspections organized through the East African Community Medicines Harmonization Initiatives (EAC – AMRH) and SADC – AMRH) - ZAZIBONA.
In some cases, GMP compliance can also be assessed through a desk review based on criteria prescribed in the Guidelines on Submission of Documentation for the Establishment of Compliance to GMP practice through Desk Assessment.
Foreign manufacturing facilities must be registered by their respective National Medicines Regulatory Authorities (NMRA) before applying to be inspected by TMDA. The application should be submitted by filling out the GMP Inspection application form. The application should be online (Click here to apply). The application must be accompanied by proof of payment of GMP inspection fees and the current site master file.
Application for GMP inspection of domestic manufacturing facilities
All domestic manufacturing facilities are inspected at least once per year. Applications for renewal of business permits are processed by the TMDA zone offices through an online portal.
For detailed information and application for establishing new manufacturing please click here.
Hospitals and Pharmacies compounding Medicinal Products
The compliance to GMP for hospitals and pharmacies involved in compounding Medicinal Products shall be assessed based on requirements prescribed in Guidelines for Production of Extemporaneous Formulations and Hospital-Based Sterile Preparations (Click here to access it). Interested health facilities and pharmacies are required to submit their applications for compounding to TMDA in writing.