(2003; 148 pages)
7.1 Model certificate of GMP
The Committee was informed of the purpose of this certificate and that they were specific to manufacturing sites and the product categories and manufacturing activities undertaken at these sites. This will help to resolve the difficulties raised during the 1999 International Conference of Drug Regulatory Authorities, where it was indicated that GMP certificates often differ in layout and type of information provided.
The Committee adopted the document “Model certificate of good manufacturing practices” (Annex 5).