WHO QAS 20.865 《研发设施GxP规范》2020草案(中英文对照版).pdfVIP

WHO QAS 20.865 《研发设施GxP规范》2020草案(中英文对照版).pdf

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Working document QAS/20.865 November 2020 DRAFT WORKING DOCUMENT FOR COMMENTS: Good practices for research and development facilities 研发设施良好规范 Please send your comments to Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technical Standards and Specifications (kopps@), with a copy to Ms Claire Vogel (vogelc@) before 6 January 2021. Please use the attached “Table of Comments” document for this purpose. Our working documents are sent out electronically and they will also be placed on the WHO Medicines website (/teams/health-product-and-policy-standards/standards-and- specifications/pharmaceuticals/current-projects) for comments under the “Working documents in public consultation” link. If you wish to receive all our draft guidelines, please send your email address to jonessi@ and your name will be added to our electronic mailing list. © World Health Organization 2020 All rights reserved. This is a draft. The content of this document is not final, and the text may be subject to revisions before publication. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means without the permission of the World Health Organization. Please send any request for permission to: Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technical Standards and Specifications, Department of Health Products Policy and Standards, World Health Organization, CH-1211 Geneva 27, Switzerland, email:

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