• 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 2: Validation of water systems for pharmaceutical use – will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems

• Appendix 3: Cleaning validation – consensus to retain, will be republished

• 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

• Appendix 7: Non-sterile process validation –update published as Annex 3, WHO Technical Report Series, No. 992, 2015 – will be republished.

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.

Source:

WHO: TRS 1003, July 2017