International collaboration in the inspection of manufacturers of active pharmaceutical ingredients has been beneficial over the last few years (1). It has enabled more efficient use of inspectional resources for participating authorities and facilitated a broader inspectional coverage as well as risk-based inspection planning, thereby benefitting public health and patients by focusing on sites of highest identified risk.
Building on the successes and experiences gained from this collaboration, WHO is participating in the launch of a pilot program alongside the Australia Therapeutic Goods Administration (TGA), Health Canada (HC), the European Medicines Agency (EMA), France’s Agence Nationale de Sécurité du Médicament et des produits de Santé (ANSM), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the United States’ Food and Drug Administration (FDA), to increase their cooperation in the inspection of manufacturers of sterile medicinal products for human use.
The terms of reference document for this initiative is available through the following: Pilot Programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use
Note: Products in scope are marketed sterile pharmaceutical medicinal products for human use of chemical origin and certain marketed therapeutic biotechnology-derived biological products (such as monoclonal antibodies and recombinant proteins). Products currently out of scope of this pilot are vaccines, cell and gene therapies and plasma derived pharmaceuticals.
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