GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

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. 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.

95 Appendix on non-sterile process validation (Appendix 7), which had been revised and was 96 adopted by the Committee at its forty-ninth meeting in October 2014. 97 98 The main text was sent out for consultation as Working document QAS/15.639 entitled 99 “Guidelines on Validation” which constitute the general principles of the new guidance on

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