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Risk assessment for tablet defects is a critical quality tool used in pharmaceutical manufacturing to 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
Risks with high RPN values should be prioritized for CAPA implementation.
✅ 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