News about GMP/cGMP


WHO: Technical Report Series 1003 published

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has recently published its 51st report (Technical Report Series No. 1003). The WHO Technical Report Series covers the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on medical and public health subjects. TRS No. 1003 summarises the outcome of the Expert Committee Meeting of October 2016 in Geneva. In addition, the 252-page report contains all adopted guidances or draft guidances in the form of Appendices.

Chapter 7 Quality Assurance – Good Manufacturing Practices of the report sums up all updates in the area of GMP. The main focus lies on the guidance on validation and its appendices:

  • Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (Revised version of June 2017). This guideline circulated for public comments in 2015. Due to a large number of comments and the difficulty of maintaining specialised technical examples a revision was agreed on: The guidance was revised  to  reflect  the  main  principles,  including  details  on  validation,  for  presentation  to  the  Committee  at  its  fifty-second  meeting.  The  design  and  implementation  examples  will  be  published  separately in a Q&A document.
  • Appendix 4: Analytical method validation – adoption of revised main text with amendments, publication is pending
  • Appendix 5: Validation of computerized systems – adoption of revised main text with amendments, publication is pending
  • Appendix 6: Qualification of systems and equipment – adoption of revised main text with amendments, publication is pending

A complete guidance package on validation including all appendices and cross- references can be expected by the end oft he year.

Furthermore, a concept paper on the preparation of new guidance on good practices for desk review is in progress. As there is no general guidance on this topic the Committee recommended proceeding with its development. The intention is to make the best possible use of available resources and existing information on compliance of sites with relevant good practices (GXP) by relying, where appropriate, on desk review of inspectional information from reliable and trusted sources rather than conducting on-site inspections. Such reliance is currently practised, for example, by PQT–Inspections and the Therapeutic Goods Administration of Australia.


WHO: TRS 1003, July 2017