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STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
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.
Working document QAS/17.694 page 6 1.141 Introduction 142 1.1 Objectives of these guidelines 143 These guidelines seek to exemplify the core stability data package 144 required for registration of active pharmaceutical ingredients (APIs) and 145 finished pharmaceutical products (FPPs), replacing the previous WHO 146 guidelines in this area (1).
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