News about GMP/cGMP


WHO: Technical Report Series 1019, 2019 published

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include all adopted guidelines in the form of Annexes.

With the publication of the 53nd Technical Report Series No. 1019 of the WHO, several new and revised Guidelines were adopted and recommended for use.

In the area of Quality Assurance – GMP:

  • Interpretation of guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems (Annex 2)
  • Good manufacturing practices for validation (revision) (Annex 3: Appendix 4 Analytical procedure validation, Appendix 5 Validation of computerized systems, Appendix 6 Guidelines on qualification)

In the area of Quality Assurance – distribution and supply chain:

  • Guidelines on import procedures for medicinal products (revision) (Annex 5)

Clicking here takes you directly to TRS 1019, that summarises and interprets all results of the 53nd WHO-Expert-Meeting of October 2018 in Geneva. The final guidelines are listed in form of annexes and will be published on the WHO website in form of single documents shortly.


WHO: Essential Medicines and Health Products