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Risk-Assessment-for-Tablet-Defects-in-Pharma
Risk assessment identify, evaluate, and control potential sources of failure that could impact tablet quality, patient safety, and regulatory compliance. These defects may arise due to issues in raw materials, equipment, process parameters, environmental conditions, or human errors.
⚠️ Common Tablet Defects
Defect Type Examples Physical Capping, lamination, chipping, sticking, picking, cracking, mottling Dimensional Weight variation, thickness issues Performance Hardness failure, disintegration delay, dissolution failure Visual Color variation, foreign particles, specks
🧭 Risk Assessment Methodology (6M or FMEA Based)
🔍 6M Analysis:
Factor Potential Risk Contribution Man Operator error, lack of training, manual handling faults Machine Poor tablet press condition, worn tooling, vibration Material Granule inconsistency, high moisture, poor compressibility Method Inadequate SOPs, inconsistent compression parameters Measurement Faulty hardness testers, uncalibrated balances Mother Nature (Environment) Humidity/temperature fluctuations affecting granule flow
⚙️ FMEA Sample Parameters
Potential Failure Mode Cause Effect Severity Occurrence Detection RPN Capping Air entrapment during compression Tablet splits 7 6 4 168 Sticking Moisture in granules Defective tablet 6 5 3 90 Weight Variation Granule segregation Dosage variation 8 4 3 96
RPN = Severity × Occurrence × Detection
✅ Control Measures
Use of validated equipment and calibrated instruments
In-process controls (e.g., weight, hardness, friability, visual inspection)Proper granulation and drying parameters
Tooling inspection and preventive maintenance
Operator training and SOP adherence
Environmental control (humidity, temperature)
📋 Documentation and Review
Risk assessment report should be part of the batch manufacturing documentation
Periodic review and update of risk based on trend data, deviations, and complaints
Link to CAPA and change control system for long-term control
