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STABILITY TESTING OF ACTIVE PHARMACEUTICAL …

Working document January 2017 Draft document for comment STABILITY TESTING OF ACTIVE 1 PHARMACEUTICAL INGREDIENTS AND 2 FINISHED PHARMACEUTICAL PRODUCTS 3 (January 2017) 4 DRAFT FOR COMMENT 5 6 World Health Organization 2017 7 All rights reserved. 8 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. 9 The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in 10 part or in whole, in any form or by any means outside these individuals and organizations (including the 11 organizations' concerned staff and member organizations) without the permission of the World Health Organization. 12 The draft should not be displayed on any website. 13 Please send any request for permission to: 14 Dr Sabine Kopp, Group Lead, Medicines Quality assurance , Technologies Standards and Norms, Department of 15 Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.

96 the medicines quality assurance group and the prequalification of medicines 97 team – assessment group held in Copenhagen on 8–9 July 2016, this analysis 98 report was discussed in detail and feedback provided by the participants to the 99 report as well as the various sections of the current guidelines. In conclusion, the

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