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. 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.)
Working document QAS/16.671/Rev.1 page 5 145 2.4 The most common analytical procedures include identification tests, assay of drug 146 substances and pharmaceutical products, quantitative tests for content of impurities and limit 147 tests for impurities. Other analytical procedures include dissolution testing and determination of 148 particle size.
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