WHO临床试验用药品GMP 草案 中英文版.pdf

Working document QAS/20.863 Good Manufacturing Practices for Investigational Product DRAFT WORKING DOCUMENT FOR COMMENTS: Goodmanufacturing practices for investigationalproducts 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 “Table of Comments” attached to this email 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: kopps@. The designations employ