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GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
www.who.intWorking 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 ...
GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …
www.who.int1.2 154 The manufacturer should demonstrate (through validation) that the analytical procedure is 155 suitable for its intended purpose. 156 157 1.3 Analytical methods, whether or not they indicate stability, should be validated. 158 159 1.4 The analytical method should be validated by research and development before being