Quality risk management: principles and industry case studies

The Pharmaceutical Quality Research Institute Manufacturing Technology Committee (PQRI-MTC) commissioned a risk-management working group to assemble industry case studies for the purpose of advancing the understanding and application of the International Conference on Harmonization (ICH) Q9 Guidelin...

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Bibliographic Details
Published in:Pharmaceutical Technology 2011-07, Vol.35 (7), p.72
Main Authors: Frank, Ted, Brooks, Stephen, Murray, Kristin, Reich, Steve, Sanchez, Ed, Hasselbalch, Brian, Obeng, Kwame, Creekmore, Richard
Format: Magazinearticle
Language:English
Subjects:
Best practice
Case studies
Decision making
International conferences
Manufacturing
Methods
Pharmaceutical industry
Principles
Product development
Quality control
Quality management
Research centers
Risk assessment
Risk management
Working groups
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Summary:The Pharmaceutical Quality Research Institute Manufacturing Technology Committee (PQRI-MTC) commissioned a risk-management working group to assemble industry case studies for the purpose of advancing the understanding and application of the International Conference on Harmonization (ICH) Q9 Guideline on quality risk management. The working group was comprised of eight representatives from industry and FDA with risk-management experience and expertise. This paper represents the outcome of the PQRI working group and provides a summary of common risk-management principles and best practices, decision-making tools to foster consistency around the use of ICH Q9, and case-study examples of risk-management applications currently in use by major pharmaceutical firms. The first of eight case studies is included with this overview article. The remainder of the case studies will appear in future issues of Pharmaceutical Technology. [PUBLICATION ABSTRACT]
ISSN:1543-2521
2150-7376