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).

Appendix 5. Validation of computerized systems (adopted, subject to the changes discussed by the Expert Committee) Appendix 6. Guidelines on qualification (adopted, subject to a review of the comments received by a subgroup of the Expert Committee) Appendix 7. Non-sterile process validation (as published in TRS 992,

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  Guidelines, Validation, Annex, Appendix, Annex 3, Appendix 5

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