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GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

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Working document QAS/16.671/Rev.1 page 3 57 BACKGROUND INFORMATION 58 59 The need for revision of the published Supplementary guidelines on good manufacturing 60 practices: validation (1) was identified by the Prequalification of Medicines Programme and a draft document was circulated for comments61 in early 2013. The focus of the revision was the

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