The PQRI–MTC Risk Management Working Group solicited and formatted a series of best-practice case studies aligned with ICH
Q9 principles. The collected case studies demonstrate that there is a wide range of applications for the use of structured
risk-management analysis to facilitate effective quality-decision activities. The studies demonstrate the baseline needed
to choose the appropriate risk methodology for the targeted need, taking into account the degree of complexity and risk involved
for the specific subject of concern. It is equally important to predefine the potential resulting risk categorizations so
as to not be influenced by the assessment results in defining appropriate response actions. Finally, once risks have been
appropriately assessed and prioritized, clear risk-mitigating actions must be defined, communicated, implemented and monitored
Ted Frank is with Merck & Co; Stephen Brooks, Kristin Murray* and Steve Reich are with Pfizer; Ed Sanchez is with Johnson & Johnson; Brian Hasselbalch is with the FDA Center for Drug Evaluation and Research; Kwame Obeng is with Bristol Myers Squibb; and Richard Creekmore is with AstraZeneca.
*To whom all correspondence should be addressed, firstname.lastname@example.org
1. FDA Global Harmonization Task Force, "Implementation of Risk Management Principles andActivities within a Quality Management
System" (Rockville, MD, 2000).
2. ICH, Q9 Quality Risk Management, 2005.
3. FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (Rockville, MD, 2006).
4. FDA, "Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites–A Pilot Risk Ranking
Model," (Rockville, MD, 2004).