Risk Assessment—Representative Non-Sterile Drug Product (Compressed Tablet) during COVID-19 Pandemic
| Manufacturing Process | Risk Identification | Risk Rating | Risk Mitigation/Critical Process Controls |
|---|---|---|---|
| Incoming material sampling and testing | Sampling is an invasive process | Moderate | Sampling booths; Personal protective equipment (PPE) |
| Warehousing | Limited environmental control | Low | Improved environmental control |
| Ingredient weighing | Weighing is an invasive process | Low to Moderate | Evaluate weighing booths and PPE |
| Excipient size reduction | Equipment cleaning | Low | Upgrade COP and CIP operations |
| Blending | Equipment cleaning | Low | Upgrade COP and CIP operations |
| Granulation— Dry Granulation—Wet | Equipment cleaning | Low | Upgrade COP and CIP operations |
| Compression | Equipment cleaning | Low | Upgrade COP and CIP operations |
| Bulk Tablet Storage | None | Low | None |
| Packaging and labeling | Packaging operations are labor intensive | Low to Moderate | Evaluate HVAC Systems; Automation of component handling; PPE |
| Finished goods warehousing | Poor environmental control | Low | Improved environmental control |
| Shipping | Lack of chain of custody | Low | Dedicated carriers |
Clean Out-of-Place (COP) and Clean In-Place (CIP).