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.

94 2006, Annex 4) (1) was identified by the Prequalification of Medicines Programme and a draft 95 document was circulated for comment in early 2013. The focus of the revision was the Appendix 96 on non-sterile process validation (Appendix 7), which had been revised and was adopted by the 97 Committee at its forty-ninth meeting in October 2014 ...

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  Guidelines, Validation, Appendix, Prequalifications, Guidelines on validation appendix 5

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