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.

120 Cleaning validation – consensus to retain 121 ... 190 2.7 Trend analysis and risk assessment should be considered at intervals to ensure that the 191 method is appropriate for its intended application. 192 2.8 193 Changes to methods should be managed in accordance with the authorized change control

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  Assessment, Guidelines, Validation, Risks, Appendix, Cleaning, Risk assessment, Guidelines on validation appendix 4, Cleaning validation

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