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(May 2016) 3 DRAFT FOR COMMENTS - World Health …

(May 2016) 3 DRAFT FOR COMMENTS - World Health

www.who.int

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 cannot be inspected or …

  Draft, Health, 2016, World, Regulatory, World health, 3 draft for comments, Comments, Expectations, Regulatory expectations

(May 2016) 3 DRAFT FOR COMMENTS - WHO

(May 2016) 3 DRAFT FOR COMMENTS - WHO

www.who.int

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

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