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.

Quality control guidelines

The term “quality control” refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substances (e.g. thin layer chromatography, infrared spectroscopy, and so on), to more complicated requirements of pharmacopoeial monographs. Activities extend to the area of quality control laboratories (e.g. good laboratory management practices, models, for example for certificates of analysis and lists of laboratory equipment, and an external assessment scheme). 

15 April 2025

TRS 1060 - Annex 9: Guidance for the graphic representation of chemical structures of pharmaceutical substances in the publications of International Nonproprietary Names and The International Pharmacopoeia

15 April 2025

TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products

26 April 2024

TRS 1052 - Annex 5: WHO/UNFPA female condom generic specification

26 April 2024

TRS 1052 - Annex 4: WHO good practices for pharmaceutical quality control laboratories

30 September 2022

TRS 1044 - Annex 9: WHO/UNFPA guidance on natural rubber latex male condom stability studies

30 June 2022

TRS 1044 - Annex 10: WHO/UNFPA technical specification for TCu380A intrauterine device

10 October 2021

TRS 1033 - Annex 6: World Health Organization/United Nations Population Fund Guidance on testing of male latex condoms

20 May 2021

TRS 1025 - Annex 4: WHO good chromatography practices

1 October 2020

TRS 1025 - Annex 1: The International Pharmacopoeia: Procedure for the development of monographs and other texts

30 September 2020

TRS 1025 - Annex 10: UNFPA-WHO technical specifications for male latex condoms

30 September 2020

TRS 1025 - Annex 11: UNFPA-WHO specifications for plain lubricants

1 October 2018

TRS 1010 - Annex 6: WHO good pharmacopoeial practices: Chapter on compounding

30 September 2018

TRS 1010 - Annex 5: WHO guidance on testing of “suspect” falsified medicines

30 September 2018

TRS 1010 - Annex 7: WHO good pharmacopoeial practices: Chapter on herbal medicines

30 September 2018

TRS 1010 - Annex 3: WHO considerations for requesting analysis of medicines samples

30 September 2018

TRS 1010 - Annex 4: WHO model certificate of analysis

30 September 2017

TRS 1003 - Annex 2: The International Pharmacopoeia: Revised concepts and future perspectives

30 September 2017

TRS 1003 - Annex 1: WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines

30 September 2016

TRS 996 - Annex 1: WHO good pharmacopoeial practices

30 September 2015

TRS 992 - Annex 2: The International Pharmacopoeia: Updating mechanism for the section on radiopharmaceuticals

30 September 2015

TRS 992 - Annex 6: WHO recommendations for quality requirements when plant‑derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients

1 October 2013

TRS 981 - Annex 1: Release procedure for International Chemical Reference Substances

30 September 2011

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

30 September 2011

TRS 961 - Annex 2: WHO good practices for pharmaceutical microbiology laboratories

30 September 2007

TRS 943 - Annex 3: WHO general guidelines for the establishment, maintenance and distribution of chemical reference substances

30 September 2007

TRS 943 - Annex 1: The International Pharmacopoeia: Related substances tests - dosage form monographs guidance notes

1 October 2002

TRS 908 - Annex 1: WHO recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products