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. 27 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft 28 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any 29 form or by any means outside these individuals and organizations (including the organizations' concerned staff and member 30 organizations) without the permission of the world health organization .

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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