The I.C.H. Q9 defines Quality Risk Management (or QRM) as:
“A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.”
In plain language QRM is:
A systematic, risk-based approach to quality management, composed of 4 elements:
- Assessment
- Control
- Communication
- Review of quality risks
QRM is especially critical in the pharmaceutical industry, where product quality can have serious effects on consumer health and safety.
QRM principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience.
Regulatory agencies expect that QRM is inherently built into the backbone of the Quality Management System (or Q.M.S.) by using a lifecycle approach.
An excellent Quality Risk Management program can be created to reduce risk to a manageable level and deliver high-quality products to protect consumers’ health.