Transcription of Quality by Design ISPE Pacific Rim08JUL2013.ppt
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Quality by Design ISPE Pacific Rim08JUL2013.ppt
Applying Quality by Design to Generic Drug ManufacturingBikash Chatterjee President & CTO Pharmatech Associates12 Agenda What is QbD? Why it has become important What companies need to know, overview How to set up a team to develop QbD Process understanding Knowledge space Design space Required statistical processes Practical application of the ideas-Case Study Review of past records to determine CPP-Case Study Development of acceptable operation range Benefits Cost savings3 QbD s Proposition QbD concerns the making of drug substances and drug products QbD is the new pharmaceutical Quality system that: Replaces current GMP concepts Does not depend on the trial and error approach of drug substance and drug product development & production Is a systemic, knowledge and risk-based Quality methodology Complies with the general purpose of product Quality .
Applying Quality by Design to Generic Drug Manufacturing Bikash Chatterjee President & CTO Pharmatech Associates 1 2 Agenda • What is …
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