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, 4.82Mb
Volume 2, 2nd updated edition -
Quality system requirements for national GMP inspectorates [pdf 1Mb]
Annex 8, WHO Technical Report Series 902, 2002 -
Pre-approval inspections [pdf 1Mb]
Annex 7, WHO Technical Report Series 902, 2002 -
Inspection of pharmaceutical manufacturers [pdf 6.4Mb]
Annex 2, WHO Technical Report Series 823, 1992 -
Inspection of drug distribution channels [pdf 7Mb]
Annex 6, WHO Technical Report Series 885, 1999 -
Guidance on GMP: Inspection Report
Annex 6, WHO Technical Report Series 908, 2003 -
Model Certificate of GMP [pdf 632kb]
Annex 5, WHO Technical Report Series 908, 2003