Transcription of GUIDELINES ON VALIDATION APPENDIX 5 VALIDATION OF ...
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GUIDELINES ON VALIDATION APPENDIX 5 VALIDATION OF ...
Working document May 2016 Draft document for comment 1 GUIDELINES ON VALIDATION APPENDIX 5 2 VALIDATION OF COMPUTERIZED SYSTEMS 3 (May 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. The draft 27 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any 28 form or by any means outside these individuals and organizations (including the organizations' concerned staff and member 29 organizations) without the permission of the world health organization .
Working document QAS/16.667 page 3 90 Background information 91 92 The need for revision of the published Supplementary guidelines on good manufacturing 93 practices: validation (World Health Organization (WHO) Technical Report Series, No. 937, 94 2006, Annex 4) (1) was identified by the Prequalification of Medicines Programme and a draft 95 document was …
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