TROUBLES DU DÉVELOPPEMENT
Chapitre C.3
Edition en français Traduction : Alice Guédon Sous la direction de : David Cohen Avec le soutien de la SFPEADA
Cureus 2024 Jan 16;16(1):e52358. doi: 10.7759/cureus.52358
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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