API MultiProduct QRA 20slides
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Vinay PatelAPI MultiProduct QRA 20slides
Uploaded by
Vinay PatelQuality Risk Assessment for
Active Pharmaceutical
Ingredients
(Multiple Product Manufacturing
Plant)
Based on ICH Q9 Quality Risk
Management Principles
Introduction
• Overview of QRA for API manufacturing plants
producing multiple products.
Purpose of QRA
• - Identify, evaluate, and control risks
• - Ensure compliance with cGMP
• - Minimize cross-contamination
• - Assure product quality, safety, and efficacy
Scope
• - Covers processes, equipment, facilities,
utilities, personnel
• - Addresses changeovers, cleaning validation,
material handling
ICH Q9 Principles
• Risk management framework for
pharmaceutical manufacturing.
Methodology Step 1: Identification
• List all potential hazards impacting product
quality.
Methodology Step 2: Analysis
• Assess severity, probability, and detectability
of risks.
Methodology Step 3: Evaluation
• Determine RPNs and rank risks.
Methodology Step 4: Control
• Implement engineering, procedural, and
administrative measures.
Methodology Step 5: Review
• Ensure continuous monitoring and
reassessment.
Risk Example: Cross-Contamination
• Hazard: Product residues between batches
• Control: Dedicated equipment, validated
cleaning
Risk Example: Label Mix-up
• Hazard: Incorrect labeling
• Control: Barcoding, line clearance
Risk Example: Cleaning Validation
• Hazard: Ineffective cleaning
• Control: Validation protocols, revalidation
Risk Example: Equipment Failure
• Hazard: Downtime and contamination
• Control: Preventive maintenance
Risk Example: Personnel Gowning
• Hazard: Contamination from personnel
• Control: Training, supervision
Risk Ranking
• Severity (S) × Probability (P) = RPN
• Higher RPN = Higher Priority
Risk Control Measures
• - Engineering controls
• - Administrative controls
• - Procedural improvements
Risk Review Frequency
• Annual review or after significant change in
processes
Benefits of QRA
• - Enhanced compliance
• - Reduced contamination risk
• - Improved safety and quality
Conclusion
• Proactive QRA implementation ensures
consistent product quality.
Final Note
• Risk management is a continuous
improvement process.
