News about GMP/cGMP


WHO: Three Draft Documents for Comments

The WHO has released three interesting documents on its website for public comments:

Inquiry regarding production of “Water for Injection”

Several pharmacopoeias (e. g. Japanese and the US Pharmacopeia), including the European Pharmacopoeia, during the past years and months adopted revised monographs on water for injections (WFI) allowing production by non-distillation technologies.

Up until now, the production of WFI had been limited to distillation only in many countries.
The monograph revisions in the context of several pharmacopoeias were the result of extensive consultations with stakeholders.
They newly allow for production of WFI by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques.

At an informal WHO consultation on good practices for health products manufacture and inspection held in April 2017, it was noted that new technologies were being adopted for the manufacture of WFI internationally, as outlined above.

This was reported to the 52nd the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The Expert Committee members noted the report and recommended that the WHO Secretariat should collect feedback on whether to revise the WHO specifications and GMP in relation to the production of WFI.

“In light of the above, feedback is being sought on whether the WHO specifications and GMP text (s):
should be revised in relation to the production of WFI allowing other purification processes as well

  • and if yes, if details on additional requirements should be added,
  • and if yes, which additional requirements should be added.”

The inquiry is now open for comments and a feedback shall be presented to the WHO Expert Committee in October 2018.

Additionally the WHO published a draft document on GMP for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms: Part 2; Interpretation of Part 1 – GMP for HVAC systems.

The document represents Part 2 of the HVAC systems guidelines. It contains non-binding examples, drawings, technical representations and interpretation in support of Part 1 of the HVAC systems guidelines.

The draft is open for comments until May 2018. A final version of the guideline shall then be presented to the WHO Expert Committee in October this year.

The third document released for public comments is a draft on Validation Appendix 6, Guidelines on Qualification.

The revision of Validation Appendix 7 non-sterile process validation which had been released in October 2014 shall now be followed by a revision of Appendix 6, Guidelines on Qualification.

A brief background:

  • There was some confusion regarding the title. It is therefore suggested to change the title to GUIDELINES ON QUALIFICATION. In this way, the general principles in qualification are addressed which can be applied for systems, equipment, etc.
  • Based on the comments, the general chapters on objective and scope were written to make it clear that the guidelines address principles of qualification that can be applied, as appropriate, to premises, systems, utilities and equipment and to include the application of risk management principles.
  • Moreover, duplication was removed, logical flow of concepts addressed and aligned with international texts and the comments.
  • The V Model has been removed based on the feedback received.
  • In the former published text on qualification, protocol formats were included. These protocol formats were extracted from training materials and were intended to serve as examples. In view of the feedback that seemingly manufacturers took them as absolute examples to be used, these examples have been removed in the current version.

The draft is open for comments until end of April 2018 and will also be presented to the Expert Committee in October 2018.


WHO "Wasser für Injektionszwecke"

WHO "GMP for HVAC systems Part 2"

WHO "Validation Appendix 6, Guidelines on Qualification"