Transcription of GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
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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.
90 Analytical method validation ... 1.4 126 The analytical method should be validated by research and development before being ... 148 particle size. 149 150 2.5 The results of analytical procedures should be accurate, legible, contemporaneous, 151 ...
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