Transcription of GUIDELINES ON VALIDATION APPENDIX 6 VALIDATION …
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Working document June 2016 Draft document for comment 1 GUIDELINES ON VALIDATION APPENDIX 6 2 VALIDATION ON QUALIFICATION OF SYSTEMS, UTILITIES 3 AND equipment 4 (June 2016) 5 DRAFT FOR COMMENTS 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 World Health Organization 2016 26 All rights reserved. 27 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft 28 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any 29 form or by any means outside these individuals and organizations (including the organizations' concerned staff and member 30 organizations) without the permission of the World Health Organization.
12.155 Qualification of “in use” systems and equipment 156 157 1. PRINCIPLE 158 159 1.1 Systems, utilities and equipment should be appropriately designed, located, installed, operated, cleaned and maintained160 to suit their intended purpose. 161 162 1.2 Products should be manufactured on qualified equipment to ensure batch-to-batch
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