Transcription of (May 2016) 3 DRAFT FOR COMMENTS - WHO | …
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(May 2016) 3 DRAFT FOR COMMENTS - WHO | …
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 .)
6 Working document QAS/16.666 page 6 130 equipment, utilities and systems, and analytical methods) are included. 131 132 1.3 The following principles apply: 133 134 the execution of validation should be in compliance with 135 regulatory expectations; 136 quality, safety and efficacy must be designed and built into the 137 product; 138 quality …
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