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GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

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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.

1.2 154 The manufacturer should demonstrate (through validation) that the analytical procedure is 155 suitable for its intended purpose. 156 157 1.3 Analytical methods, whether or not they indicate stability, should be validated. 158 159 1.4 The analytical method should be validated by research and development before being

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