QbD and Process Validation - Complementary Lifecycle Approaches (single user digital version)

Feb 2011
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This chapter is taken from the book Quality By Design: Putting Theory Into Practice

This subject matter expert discusses the QbD process as it applies to successful integration of this method with newer concepts such as Critical Quality Attributes (CQA), Critical Process Parameters (CPP) and design space in an organized, risk-based, focused approach. He also describes how to apply them to pharmaceutical manufacturing including analytical methods and quality systems.

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Format: PDF (1 file 336 KB)

About the Authors

About the Author

Paul L. Pluta, Ph.D., is a pharmaceutical scientist with extensive industrial development, manufacturing, and management experience. He has been involved in nearly all phases of product development and manufacturing for small molecule dosage forms. His validation experience includes manufacturing process validation, cleaning validation, and qualification of associated support systems. Dr. Pluta is also Adjunct Associate Professor at the University of Illinois at Chicago (UIC) College of Pharmacy with involvement in undergraduate and graduate student teaching and mentoring. He is also editor-in-chief of the Journal ofValidation Technology and the Journal of GXP Compliance, both publications of the Institute of Validation Technology/Advanstar Communications.