Transcription of STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
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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.
Working document QAS/17.694 page 4 78 conditions for hot and humid regions. Due to this divergence in global stability 79 testing requirements, the ICH Steering Committee has decided to withdraw ICH 80 Q1F and to leave definition of storage conditions in Climatic Zones III and IV to the respective regions and WHO [web81 link to the WHO guidelines](1).
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