GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

Working document September 2018. Draft document for comments 1. 2 GUIDELINES ON VALIDATION APPENDIX 4. 3 ANALYTICAL METHOD VALIDATION . 4. 5 (September 2018). 6. 7 DRAFT FOR COMMENTS. 8. 9. Please forward any comments you may have on the attached text to Dr Sabine Kopp, Group Lead, 10. 11. Medicines Quality Assurance, Technologies, Standards and Norms with a copy to Mrs Xenia Finnerty by 15 November 2018. 12. 13. Medicines Quality Assurance working documents will only be sent out electronically and will 14. 15. also be placed on the Medicines website for comments under Current projects . If you have 16. not already received our draft working documents, please send your email address (to 17. 18. and we will add it to our electronic mailing list. 19. 20. 21. 22. 23 World. Health Organization 2018. 24. 25 All rights reserved. 26. 27 This draft is intended for a restricted audience only, the individuals and organizations having received this draft.)

1.2 121 The manufacturer should demonstrate (through validation) that the analytical procedure is 122 suitable for its intended purpose. 123 1.3 Analytical methods,124 whether or not they indicate stability, should be validated. 125 1.4 126 The analytical method should be validated by research and development before being

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  Guidelines, Methods, Validation, Analytical, Analytical method

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