Transcription of GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
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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.
Working document QAS/16.671 page 5 180 tests for impurities. Other analytical procedures include dissolution testing and determination of 181 particle size. 182 183 2.5 The results of analytical procedures should be accurate, legible, contemporaneous, 184 original, reliable and reproducible. All results should be archived for an appropriate period of
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