What is Quality Risk Management (QRM)?
The ICH 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 simple terms QRM is a systematic, risk-based approach to quality management, composed of 4 key elements:
- Assessment
- Control
- Communication
- And Review of Quality Risks
QRM is a preventative approach that helps companies avoid being reactive to potential issues that may arise at any stage of the product lifecycle.
QRM also increases quality by increasing productivity and information exchange. This can significantly minimize the amount of catch-up effort required to mitigate the effects of poor quality.
QRM gives a reason for focusing resources and time on truly important things, instead of focusing resources and time on low-risk activities, process events, or systems.
Risk management helps companies make better, more informed decisions. It also gives regulators more confidence in a company’s ability to deal with possible hazards and influences the scope and level of direct regulatory monitoring.
