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.

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Quality Assurance

TRS 1033 - Annex 4: WHO Guideline on data integrity

10 October 2021

TRS 1033 - Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

17 February 2021

TRS 986 - Appendix 6: Interagency finished pharmaceutical product questionnaire

25 January 2019

TRS 1019 - Annex 3: Good manufacturing practices: guidelines on validation

10 October 2016

TRS 996 - Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials

10 October 2016

TRS 966 - Annex 7: Guidelines on the conduct of surveys of the quality of medicines

30 June 2015

Guidelines on the conduct of surveys of the quality of medicines - QAS/15.630

10 October 2014

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

30 September 2014

TRS 986 - Annex 3: WHO model quality assurance system for procurement agencies

Quality Assurance

TRS 1033 - Annex 4: WHO Guideline on data integrity TRS 1033 - Annex 4: WHO Guideline on data integrity

TRS 1033 - Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation TRS 1033 - Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

TRS 986 - Appendix 6: Interagency finished pharmaceutical product questionnaire TRS 986 - Appendix 6: Interagency finished pharmaceutical product questionnaire

TRS 1019 - Annex 3: Good manufacturing practices: guidelines on validation TRS 1019 - Annex 3: Good manufacturing practices: guidelines on validation

TRS 996 - Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials TRS 996 - Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials

TRS 966 - Annex 7: Guidelines on the conduct of surveys of the quality of medicines TRS 966 - Annex 7: Guidelines on the conduct of surveys of the quality of medicines

Guidelines on the conduct of surveys of the quality of medicines - QAS/15.630 Guidelines on the conduct of surveys of the quality of medicines - QAS/15.630

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

TRS 986 - Annex 3: WHO model quality assurance system for procurement agencies TRS 986 - Annex 3: WHO model quality assurance system for procurement agencies