(May 2016) 3 DRAFT FOR COMMENTS - World …

Working document May 2016 . DRAFT document for comment 1. 2 GUIDELINES ON VALIDATION. 3 (May 2016 ). 4 DRAFT FOR COMMENTS . Should you have any COMMENTS on the attached text, please send these to Dr S. Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms with a copy to Ms Marie Gaspard by 12 July 2016 . Medicines Quality Assurance working documents will be sent out electronically only and will also be placed on the Medicines website for comment under Current projects . If you do not already receive our DRAFT working documents please let us have your email address (to and we will add it to our electronic mailing list. 5. 6 World Health Organization 2016 . 7 . All rights reserved. 8 This DRAFT is intended for a restricted audience only, the individuals and organizations having 9 received this DRAFT . The DRAFT may not be reviewed, abstracted, quoted, reproduced, transmitted, 10 distributed, translated or adapted, in part or in whole, in any form or by any means outside these 11 individuals and organizations (including the organizations' concerned staff and member 12 organizations) without the permission of the World Health Organization.)

7 Working document QAS/16.666 page 7 171 2.3172 The general text in the main part of these guidelines may be 173 applicable to validation and qualification of premises, equipment, utilities,

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