Transcription of Annex 3 - WHO
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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 collection and evaluation of data, throughout the product life-cycle, which provides documented scientific evidence that a process is capable of consistently delivering quality products. prospective validation. Validation carried out during the development stage, on the basis of a risk analysis of the production process, which isbroken
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