By Robert G. Kieffer, PhD, RGK Consulting
Since the publication of ICH Q9: Quality Risk Management in 2005 (1), there has been much written about the application of risk management to the production process, product development and validation (2–5). Relatively little has been published about its application to some of production’s supporting processes that comprise an important part of the pharmaceutical quality system (PQS). Annex 2 of ICH Q9 outlines the application of Quality Risk Management (QRM) to some of these supporting processes—change management/ change control, quality defects, auditing/ inspection, documentation, training, calibration/preventive maintenance and periodic review. The use of QRM should result in more effective and more efficient processes.