Transcription of GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
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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.
92 Appendix 5 93 Validation of computerized systems – (update –see working document QAS/16.667). 94 95 Appendix 6 96 Qualification of systems and equipment – update in process. 97 98 Appendix 7 99 Non-sterile process validation – update already published as Annex 3, WHO Technical Report 100 Series, No. 992, 2015.
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