Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Inspections

Inspections are part of the overall quality management system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization to manufacture 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 falsified medicines. 

 

20 May 2021

TRS 1025 - Annex 4: WHO good chromatography practices

20 April 2020

TRS 1025 - Annex 6: Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance

20 April 2020

TRS 1025 - Annex 5: Quality management system requirements for national inspectorates

30 September 2018

TRS 1010 - Annex 9: WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions

30 September 2016

TRS 996 - Annex 4, Appendix 2: WHO good manufacturing practices inspection: Example of a risk category assessment of the site depending on level of compliance and inspection frequency

30 September 2016

TRS 996 - Annex 4, Appendix 1: WHO guidance on good manufacturing practices: Model inspection report

31 October 2015

TRS 992 - Annex 4: General guidance on hold-time studies

10 October 2014

TRS 986 - Annex 4: Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection

31 October 2011

TRS 961 - Annex 14: WHO guidelines for drafting a site master file

30 September 2011

TRS 961 - Annex 13: WHO guidelines for preparing a laboratory information file

30 September 2010

TRS 957 - Annex 7: WHO guidelines for the preparation of a contract research organization master file

30 September 2002

TRS 902 - Annex 7: WHO guidelines on pre-approval inspections

30 September 1992

TRS 823 - Annex 2: Inspection of pharmaceutical manufacturers