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GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT …

Working document September 2015 Draft document for comment GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES (SEPTEMBER 2015) DRAFT FOR COMMENT World Health Organization 2015 All rights reserved. This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and member organizations) without the permission of the World Health Organization.

Working document QAS/15.624 page 3 BACKGROUND During an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines’ manufacturing held by the World Health Organization

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