Appendix 7 of the WHO guidelines provides support with regard to non-sterile process validation. Although this appendix was revised at the end of 2015, it is apparent that further changes to WHO guidelines are in sight. One of these changes concerns the draft guideline on process validation, which was available for comments until 12 July 2016. The key elements of the guideline are summarised here.
The draft contains 21 pages divided into 13 chapters, plus a references section. It is an umbrella guideline as it cross-references other appendices of the WHO Technical Report Series, and it is expected to replace Annex 4 of WHO Technical Report Series No. 937 from 2006. The appendices referenced include:
- Appendix 1: Validation of HVAC systems
- Appendix 2: Validation of water systems for pharmaceutical use
- Appendix 3: Cleaning validation
- Appendix 4: Analytical method validation
- Appendix 5: Validation of computerized systems
- Appendix 6: Qualification of systems and equipment
The draft guideline re-emphasises that validation is an essential part of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP), encompassing qualification and a lifecycle comprising an “ongoing review” for continuous improvement. The necessity, scope and depth of validation activities should be based on quality risk management principles.
In addition, the document addresses the relationship between validation and qualification. “Qualification and validation are essentially the same”, whereby qualification is normally used in relation to equipment and utilities, and validation in relation to systems and processes.
Furthermore, the document emphasises that a concise and clear Validation Master Plan is a GMP requirement and should be available. The validation master plan should be regularly reviewed and the GMP status should be kept up to date.
The minimum requirements for validation and qualification protocols are also fairly detailed. The document points out that there should be a description of how results will be analysed, including statistical analyses where appropriate. For qualification and validation reports, the focus of reporting is put on statistical analyses where possible. Final approval of reports should be given by the quality assurance department.