Inspections
Inspections are part of the overall drug quality assurance system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization for the manufacture of specific pharmaceutical products, usually in relation to an application for marketing authorization. A further aspect of pharmaceutical inspection is monitoring the quality of pharmaceutical products in distribution channels, from the point of manufacture to delivery to the recipient, as a means of eliminating the hazard posed by the infiltration of counterfeit drugs.
Related documents
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Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
pdf, 5.51Mb
Volume 2, 2nd updated edition -
Quality system requirements for national GMP inspectorates
pdf, 114kb
Annex 8, WHO Technical Report Series 902, 2002 -
Pre-approval inspections
pdf, 88kb
Annex 7, WHO Technical Report Series 902, 2002 -
Inspection of pharmaceutical manufacturers
pdf, 602kb
Annex 2, WHO Technical Report Series 823, 1992 -
Inspection of drug distribution channels
pdf, 794kb
Annex 6, WHO Technical Report Series 885, 1999 -
Guidance on GMP: Inspection Report
pdf, 79kb
Annex 6, WHO Technical Report Series 908, 2003 -
Model Certificate of GMP
pdf, 66kb
Annex 5, WHO Technical Report Series 908, 2003