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CONTINUOUS QUALITY VERIFICATION (CQV) G.K.Raju, Ph.D. Pharmaceutical Manufacturing Initiative (PHARMI), MIT Program on the Pharmaceutical Industry, Massachusetts Institute of Technology
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DESCRIBING THE OPPORTUNITY IN ROUTINE MANUFACTURING
WHICH PROCESSES?
PROCESS A WITH QC TESTS
PROCESS A WITH CYCLE TIMES
PROCESS B WITH QC TESTS
PROCESS B WITH CYCLE TIMES
PROCESS C WITH QC TESTS
PROCESS C WITH CYCLE TIMES
PROCESS D WITH QC TESTS
PROCESS D WITH CYCLE TIMES
PROCESS D WITH QC TESTS: Cycle Times including BULK ACTIVE
PROCESS D WITH QC TESTS Cycle Times
WHAT DRIVES THE QC TESTING TIMES?
WHICH PROCESSES?
PROCESS E WITH QC TEST POINTS
PROCESS E WITH QC TEST TIMES
WHICH PROCESSES?
PROCESS F: LIQUID LINE
PROCESS F: LIQUID LINE WITH CYCLE TIMES
PERCEIVED PROCESS CYCLE TIMES: SUMMARY
CYCLE TIME COMPONENTS
ON-LINE TECHNOLOGY IMPACTS DOMINANT CYCLE TIMES
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DESCRIBING THE OPPORTUNITY IN PROCESS DEVELOPMENT
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WHICH PROCESSES?
FOCUS
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PROCESS D: BLENDING PROCESS DEVELOPMENT
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APPROACH TO LEARNING:
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WHAT ARE THE IMPLICATIONS?
Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP)
PROCESS A WITH CURRENT QC TESTS AND NEW POSSIBILITIES
Need to Focus on Both Material Flow and Information Flow
Manufacturing Information Management: Has Hardware and Software Components
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CQV: BENEFITS
Learning Curve: Cycle Times
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PRODUCT LIFE CYCLE: OPPORTUNITIES
Pharmaceutical Manufacturing: Opportunity Areas
ACKNOWLEDGEMENTS
NOTE ON CONTEXT
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