Quality Risk Management (QRM) is a structured approach designed to assess, control, review, and communicate potential risks to the quality of pharmaceutical products throughout their lifecycle. It is especially critical during the introduction of new products, ensuring compliance, safety, and product effectiveness.
Key Steps in the QRM Process
The QRM process includes the following core phases:
- Risk Assessment – Identifying, analyzing, and evaluating potential risks.
- Risk Control – Implementing strategies for risk reduction or acceptance.
- Risk Review – Ongoing evaluation and improvement of the risk management process.
QRM relies on scientific tools and methodologies to make informed decisions. These tools can be used individually or in combination, based on the nature and severity of the risk. Proper tool selection is essential and should align with the specific risk level.
Commonly Used QRM Tools:
- FMEA (Failure Mode and Effects Analysis)
- Root Cause Analysis
- Cause and Effect Diagrams
- Preliminary Hazard Analysis
- Process Mapping
- Flowcharting
- Brainstorming Sessions
- HACCP (Hazard Analysis and Critical Control Points)
- FTA (Fault Tree Analysis)
- Decision Analysis
- Statistical Tools
Six Key Parameters for Risk Assessment During New Product Introduction
1. QRM Within Change Control
- Evaluates whether existing risk assessments are impacted.
- Identifies the need for new risk assessments.
2. Product Quality Risk Assessment (PQRA)
- Conducted using a Quality by Design (QbD) approach.
- Assesses product quality attributes and their severity.
- Performed before the first GMP pivotal manufacturing campaign.
- Reviewed during process transfers to new manufacturing sites.
3. Cross Contamination Risk Assessment
- Ensures appropriate facility, equipment, and environmental controls are in place.
- Determines controls required to prevent cross-contamination.
- Aids in selecting Environmental Monitoring (EM) locations and frequencies based on risk analysis.
4. Process Risk Assessment
- Identifies risks in the manufacturing process using tools like FMEA.
- Focuses on severity, likelihood, and detectability.
- Applies to activities such as filling, inspection, and interventions.
- Supported by comprehensive data and detection controls.
5. Quality Risk Assessment for Equipment and Automated Systems (QRAES)
- Follows a risk-based approach for equipment qualification.
- Defines control measures before equipment validation.
- Integrates procedural controls into process FMEA.
6. Raw Material Risk Assessment
- Evaluates all active GMP materials and components.
- Determines necessary manufacturing controls.
- Considers raw material characteristics (e.g., safety, complexity, contaminants, elemental impurities).
- Continuously reviewed throughout the product lifecycle.
Post-Assessment Actions
After risk assessments are completed, organizations implement appropriate risk mitigation and control strategies to address critical issues. Regular reviews and updates to risk assessments ensure ongoing compliance and product safety.
ALSO READ: Validation of CAPA through Risk Management
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