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PubMed
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History
- Published online June 20, 2011.
Copyright & Usage
© PDA, Inc. 2011
Author Information
- Beth Junker,
- Mike Kosinski,
- David Geer,
- Rajiv Mahajan,
- Michel Chartrain,
- Brian Meyer,
- Peter Dephillips,
- Yang Wang,
- Randy Henrickson,
- Katie Ezis and
- Mark Waskiewicz
- Bioprocess Development, Vaccines Research and Pre-Clinical Development, Biologics Manufacturing Sciences & Commercialization, Global Vaccines Technology and Engineering/Global Biologics Quality, Merck and Co, Inc.
- Corresponding author: Beth Junker, RY80Y-130, PO Box 2000, Merck & Co, Rahway NJ 07065, 1-732-594-7010, beth.junker{at}merck.com
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- Article
- Abstract
- Introduction
- Related Initiatives
- QbD Project Approach
- Concept Phase Project Charter
- Concept Phase Current State Assembly
- Concept Phase House-of-Quality (HOQ) Development & Critical-to-Quality (CTQ) Summary
- Design/Optimize Phase Approach
- Design/Optimize Phase Outcome
- Verify Phase Identification of Gaps from the Design/Optimize Phase
- Internal Pilots and Mentoring Approach to Verify Detailed Design
- Implementation Planning
- Implementation Control Mechanisms
- Summarized Efforts Towards QbD Success
- Acknowledgements
- Footnotes
- References
- Figures & Data
- References
- Info & Metrics
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