GOOD MANUFACTURING PRACTICES FOR HEATING, …

Working document February 2018 Draft document for comment 1 2 GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION 3 AND AIR- conditioning SYSTEMS FOR NON-STERILE 4 PHARMACEUTICAL DOSAGE FORMS: PART 2 5 6 INTERPRETATION OF PART 1 GMP FOR HVAC SYSTEMS 7 8 (February 2018) 9 DRAFT FOR COMMENT 10 11 12 13 14 15 World Health Organization 2018 16 All rights reserved. 17 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The 18 draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, 19 in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and 20 member organizations) without the permission of the World Health Organization.

working document qas/18.759 page 2 41 42 schedule for the proposed adoption process of document qas/18.757: 43 good manufacturing practices for heating, ventilation and air- conditioning systems44 for non-sterile pharmaceutical dosage forms: part 2 45 46 47 interpretation of part 1 – gmp for hvac systems 48 49 preparation of document by dr a. j. van zyl,

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