Quality Risk Management (QRM)

Abstract

Risk assessment is a critical process that involves identifying, analyzing, and evaluating potential hazards and risks associated with the drug substance or product throughout the product development and manufacturing process. Quality by design (QbD) principles and quality risk management (QRM) are encouraged by the US FDA for consistent adherence to predefined quality attributes and specifications. QRM should be applied during various stages of product development to identify and mitigate potential risks, using technical risk assessment methodology to facilitate science-based decision-making in a systematic, objective, and efficient manner. Semi-quantitative risk assessment (SQRA) can help speed decision-making in fast-paced industrial environments by prioritizing projected product risks that may impact end users. In pharmaceutical manufacturing, it is often challenging to identify and define failures, making product and process risk more relevant and practical to assess. The use of software with an audit trail can efficiently update a risk assessment platform for a specific quality attribute, reducing the need for additional time for rework or repeat risk assessments for complex multiunit operations. Modern quality systems and risk assessment tools that utilize product and process knowledge can simplify regulatory approval requirements for post-approval changes to facilities, equipment, and processes.