Search results with tag "Guideline on submission of"
ASEAN GUIDELINE ON SUBMISSION OF …
www.hsa.gov.sg2 GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION 1. INTRODUCTION Process Validation is a means of ensuring that manufacturing processes are capable of consistently
GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR A ... …
www.who.intworking document qas/13.522/rev.1 page 2 36 37 schedule for the proposed adoption process of document 38 qas/13.522: 39 guidelines on submission of documentation for a multisource
GUIDELINE ON SUBMISSION OF …
www.pharmalytik.comworking document qas/10.373/rev.1 restricted 1 2 3 4 5 guideline on submission of documentation for a 6 multisource (generic) finished pharmaceutical 7 …
GUIDELINE ON SUBMISSION OF …
www.who.intWorking document QAS/10.375 page 4 69 70 1. INTRODUCTION 71 1.1 Background 72 73 WHO Technical Report Series, No. 953 (TRS No. 953), Annex 3 (2009) entitled Procedure 74 for Prequalification of Pharmaceutical Products outlines the procedure and considerations for 75 the process undertaken by WHO in providing United Nations …