Transcription of STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
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Working document January 2017. Draft document for comment 1 STABILITY TESTING OF ACTIVE . 2 PHARMACEUTICAL ingredients AND. 3 finished PHARMACEUTICAL PRODUCTS. 4 (January 2017). 5 DRAFT FOR COMMENT. Should you have any comments on the attached text and the STABILITY conditions for WHO Member States (MS) by Region, appendixed to the previous version of this guidance ( ), please send these to: Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, World Health Organization, 1211 Geneva 27, Switzerland; email: fax: (+41 22) 791 4730;. and to Mrs Ksenia Finnerty by 15 March 2017. In line with the recommendations of the WHO Expert Committee on Specifications for PHARMACEUTICAL Preparations the list of MS STABILITY conditions is maintained as a living document. Comments received after the indicated date will also be considered. Working documents are sent out electronically and they will also be placed on the Medicines website for comment.
Working document QAS/17.694 page 5 102 Stability testing of active pharmaceutical ingredients and 103 finished pharmaceutical products 104 1. Introduction 1.1 Objectives of these guidelines105 106 1.2 Scope of these guidelines 107 1.3 General principles 108 2. Guidelines 109 2.1 Active pharmaceutical ingredient 2.1.1 …
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