Transcription of QUALITY SYSTEMS APPROACH - Indian …
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QUALITY SYSTEMS APPROACH - Indian …
11 QUALITY SYSTEMS APPROACH FORCGMP IMPLEMENTATION Philosophy to Practice63rdIPC Bengaluru17thDecember Labs LimitedQUALITY SYSTEMS APPROACH FOR CGMP IMPLEMENTATION2 CONTENTS: QUALITY SYSTEMS ? -CURRENT ISSUES GMPs & QMS2. STRUCTURE & ELEMENTS OF PHARMACEUTICAL QUALITY SYSTEMS PQS (US FDA , ICH Q10) RESPONSIBILITY PQS REQUIREMENTS REGULATORY EXPECTATIONSQUALITY SYSTEMS APPROACH FOR CGMP IMPLEMENTATION3 In the recent years the Indian Pharmaceutical Sector has emerged as one of the world's leading and fastest growing markets. The industry has acquired a commendable position in the global pharma market as a supplier of high- QUALITY , low-cost generic drugsBACKGROUND: Indian Pharma Industry-A Success StoryQUALITY SYSTEMS APPROACH FOR CGMP IMPLEMENTATION4A leading global provider already World s 3rdlargest generics producer Over US$ 8 Billion exports to 200 countries : 41% to , EU & growing @ 20%+Growing Mfg. & Market 179 USFDA, 84 MHRA; 153 EDQM; 814 WHOcGMP;& 49 sites have CEP Approved facilitiesBACKGROUND: Indian Pharmaceutical Industry A Success StoryQUALITY SYSTEMS APPROACH FOR CGMP IMPLEMENTATION5 WHY QUALITY SYSTEMS ?
QUALITY SYSTEMS APPROACH FOR CGMP IMPLEMENTATION 3 In the recent years the Indian Pharmaceutical Sector has emerged as …
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