Definition and Importance of Quality risk management
Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle.
It ensures that high-quality products are delivered to patients.
Principles of QRM
Scientific Knowledge: Decisions are based on scientific understanding.
Risk-Based Approach: Focus on critical areas that impact product quality.
Lifecycle Management: Continuous process throughout the product's life.
QRM Process Steps
Risk Identification: Determining what could go wrong.
Risk Analysis: Understanding the nature of the risk and its potential impact.
Risk Evaluation: Comparing the estimated risk against given risk criteria.
Risk Control:
Risk Reduction: Implementing actions to mitigate risk.
Risk Acceptance: Deciding whether residual risk is acceptable.
Risk Communication: Sharing information about risks and risk management between stakeholders.
Risk Review: Monitoring and reviewing risk over time.
Tools Used in QRM
Failure Mode and Effects Analysis (FMEA)
Hazard Analysis and Critical Control Points (HACCP)
Fault Tree Analysis (FTA)
Risk Ranking and Filtering
Application of QRM in Technology Transfer
Process Understanding: Identifying critical process parameters.
Equipment Qualification: Assessing equipment suitability and risks.
Analytical Method Transfer: Ensuring methods are robust and reliable.
Regulatory Compliance: Demonstrating control over risks to regulatory bodies.