Annex 3 - WHO

119 Annex 3 Good manufacturing practices: guidelines on validation Background The need for revision of the published World Health Organization (WHO) Supplementary guidelines on good manufacturing practices: validation (1) was identified by the Prequalification of Medicines Programme and a first draft document was circulated for comment in early 2013. The focus, at that time, was revision of the appendix on Non-sterile process validation (Appendix 7) (2), which had been revised and was adopted by the ECSPP at its Forty-ninth meeting in October 2014 (3). The overarching text presented in this Annex constitutes the general principles of the new guidance on validation .

Cleaning validation (as published in TRS and TRS 937, Annex 4, 2006 and as cross-reference to TRS 970, Annex 2, 2012 (5) Appendix 4. Analytical procedure validation (adopted, subject to ... when changes are made, depending on the outcome of risk assessment; where necessary or indicated, based on the outcome ofperiodic

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  Assessment, Validation, Annex, Risks, Cleaning, Risk assessment, Annex 3, Cleaning validation

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