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GUIDELINES ON VALIDATION APPENDIX 6 VALIDATION …

Working document June 2016 Draft document for comment 1 GUIDELINES ON VALIDATION APPENDIX 6 2 VALIDATION ON QUALIFICATION OF SYSTEMS, UTILITIES 3 AND EQUIPMENT 4 (June 2016) 5 DRAFT FOR COMMENTS 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 world health organization 2016 26 All rights reserved.

Working document QAS/16.673 page 3 91 Background information 92 93 The need for revision of the published Supplementary guidelines on good manufacturing 94 practices: validation (World Health Organization (WHO) Technical Report Series, No. 937, 2006, Annex 4) was95 identified by the Prequalification of Medicines Programme and a draft 96 document was circulated for …

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