Risk Assessment—Representative Sterile Drug Products (Liquid-filled Stoppered Glass Vials) 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 in a warehouse | Moderate | Sampling booths and personal protective equipment (PPE) |
| Warehousing | Limited environmental control | Low | Improved environmental control (IEC) |
| Ingredient weighing | Weighing is a labor-intensive process | Low to Moderate | Evaluate weighing booths and PPE |
| Bulk solution preparation | Solution preparation is a potentially invasive process | Low to Moderate | Use of Restricted Access Barrier Systems (RABS) and isolators |
| Packaging component preparation | Component loading and unloading is a potentially invasive process | Low | Automation of component handling; Depyrogenation and sterilization of vials and stoppers |
| Sterile filtration and aseptic filling and Sealing | Aseptic processing is a potentially invasive process | Low | Use of RABS and isolators |
| Visual inspection | Inspection is an invasive process | Low | Handling automation; IEC; PPE |
| Packaging and labeling | Packaging is an invasive process | Low | Handling automation;IEC; PPE |