Transcription of GUIDELINES ON VALIDATION APPENDIX 4 …
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GUIDELINES ON VALIDATION APPENDIX 4 …
Working document June 2016 Draft document for comment 1 GUIDELINES ON VALIDATION APPENDIX 4 2 ANALYTICAL METHOD VALIDATION 3 (June 2016) 4 DRAFT FOR COMMENTS 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 World Health Organization 2016 25 All rights reserved. 26 This draft is intended for a restricted audience only, the individuals and organizations having received this draft.
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 …
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