- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Mots-clés > GMP inspection
- Mots-clés > GMP inspectors and manufacturers
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > inspection - GMP
- Mots-clés > inspection of manufacturing sites
- Mots-clés > inspection of pharmaceutical products - standard operating procedures
- Mots-clés > regulatory institutional capacity
(2015; 29 pages)
Anisfeld, M. H., Kim, E.M., Aimiuwu, J., Thumm M., 2015. Assessment of the Good Manufacturing Practices (GMP) Inspection Program of the Bangladesh Directorate General of Drug Administration. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
As a part of its ongoing support to build the capacity of the DGDA, the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) team conducted a rapid assessment of the capacity of the Good Manufacturing Practices (GMP) inspection program at the Directorate General of Drug Administration (DGDA). GMP is part of the quality assurance system for medicines, which helps to ensure that medicinal products are consistently produced and controlled to meet the quality standards appropriate to their intended use, as required by national drug regulatory authorities. The GMP inspection is also a critical component of the medicines registration review process.
To assess the capacity of the GMP inspection program of the DGDA, the SIAPS team reviewed onsite inspection practices as well as relevant documents. To evaluate the legal framework and current tools used by the DGDA inspectorate, the SIAPS team reviewed the applicable laws, regulations, standard operating procedures (SOPs), guidance documents, checklists, and inspection reports of the DGDA. To assess the current GMP inspection practices of the DGDA inspectorate, the SIAPS team accompanied DGDA inspectors to observe inspection practices at two GMP-certified manufacturing sites.