News about GMP/cGMP


WHO: Three new draft guidelines published

The World Health Organisation (WHO) has published three new draft guidelines, which are currently available for comments. In September 2020, all comments will be consolidated and reviewed. The documents will then be prepared for discussion and presented at the 55th virtual meeting of the ECSPP (WHO Expert Committee on Specifications for Pharmaceutical Preparations). It is scheduled to take place from 12 to 16 October 2020.

In August 2020 the WHO published a third revision of the document Good regulatory practices for regulatory oversight of medical products containing 46 pages. The document is intended to reflect Member States with widely-recognized principles of Good Regulation Practice (GRP). The nine principles outlined are: 

  • Legality  
  • Consistency  
  • Independence  
  • Impartiality  
  • Proportionality  
  • Flexibility  
  • Clarity  
  • Efficiency  
  • Transparency   

They are the result of a comprehensive review of public documents developed by governments and multilateral organisations and concern all authorities responsible for the regulatory oversight of medicinal products.


The document Good manufacturing practices: water for pharmaceutical use containing 30 pages was published in July 2020 as a second revised draft for the next round of public consultation. In short, the following changes were made:  

  • The chapter on "Highly Purified Water (HPW)" was omitted.  
  • The chapter on "Biocontamination control techniques" is also no longer available.  
  • The chapter on "System Sanitisation and bioburden control" is more comprehensive now,  
  • as well as the chapter "Bulk water for injections".  
  • The chapter "Good practices for water systems" now distinguishes between drinking water and purified water/WFI. 


The third document is the second draft revision of the Guideline on data integrity from June 2020 containing 29 pages. In its final version it will replace the WHO Guidance on good data and record management practices (Annex 5, WHO Technical Report Series, No 996, 2016) (1). The document has been harmonised with existing DI guidelines, e. g. the US FDA, as far as possible. In terms of content, the wheel might not be reinvented in this draft, but a clear structure and language speak for the document. The examples of quality risk management and data integrity assessments are well worth mentioning, as well as the ten examples of good documentation practices in data integrity.