CONTINUOUS QUALITY VERIFICATION (CQV) G.K.Raju, Ph.D. Pharmaceutical Manufacturing Initiative (PHARMI), MIT Program on the Pharmaceutical Industry, Massachusetts Institute of Technology

7/20/01


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Table of Contents

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

Author: James C. Leung