(May 2016) 3 DRAFT FOR COMMENTS - WHO

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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.)

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, systems, processes and procedures.174

  Draft, 2016, 3 draft for comments, Comments