GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
Working document QAS/16.671 page 3 90 Background information 91 92 The need for revision of the published Supplementary guidelines on good manufacturing practices: validation 93 (1) was identified by the Prequalification of Medicines Programme and a 94 draft document was circulated for comment in early 2013. The focus of the revision was the 95 Appendix on non-sterile process validation ...
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www.who.int6 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 tested into the product;
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