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. The following appendices included in this Annex address specific aspects of validation and are intended to complement the general text on validation: Appendix 1.

WHO guidelines on quality risk management (8). 5.11 Where necessary, worst-case situations or specific challenge tests should be considered for inclusion in the qualification and validation. 6. Documentation. 6.1 Documents associated with qualification and validation may include: validation master plan;

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