GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL METHOD ...

Working document QAS/16.671 page 3 90 Background information 91 92 The need for revision of the published Supplementary guidelines on good manufacturing practices: validation 93 (1) was identified by the Prequalification of Medicines Programme and a 94 draft document was circulated for comment in early 2013. The focus of the revision was the 95 Appendix on non-sterile process validation ...

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