- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > African Medicines Regulatory Harmonization (AMRH)
- Palabras clave > Good Manufacturing Practices (GMP)
- Palabras clave > harmonization of medicines regulation
- Palabras clave > inspection - GMP
- Palabras clave > inspection of manufacturing sites
- Palabras clave > International Conference on Harmonisation (ICH)
- Palabras clave > medicines registration
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > regulatory harmonization
- Palabras clave > regulatory institutional capacity
(2014; 336 pages)
This Compendium has been prepared to enable effective implementation of Good Manufacturing Practices (GMP) inspection activities under the EAC Regulation Harmonization Programme. The Compendium will guide GMP inspectors in preparing for and performing GMP inspection activities of Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPP). It will serve as one-stop reference on GMP.
The Compendium highlights general conditions and other pertinent requirements that are necessary for carrying out GMP inspections. It is divided into various sections describing the types of inspections, qualifications, training and experience required for inspectors as well as code of ethics and conduct to be observed by inspectors when engaged in inspection activities.
In addition, the Compendium outlines procedures to be followed when preparing and planning for joint inspection, reporting requirements including format and classification system adopted for non-compliances observed during GMP inspection.
It is also expected that the Compendium shall help inspectors to conduct GMP inspection with integrity and diligence. The Code of Ethics and Conduct for Inspectors and confidentiality agreement for performance have also been outlined with the objective to remind inspectors on their ethical and moral obligations when engaged in GMP inspection activities.
Adherence to requirements outlined in this Compendium and the referenced complementary technical documents will enable consistent conduct of GMP inspections including uniform reporting and consequently amicable decision making that minimizes complaints from manufacturers. It is therefore anticipated that the GMP inspectors shall read this Compendium and diligently apply what has been documented.