Risk Assessment—Management of Manufacturing Materials during COVID-19 Pandemic
| Materials | Risk Identification | Risk Rating | Risk Mitigation/Critical Process Controls |
|---|---|---|---|
| Pharmaceutical Excipients | Excipients derived from plant, animal, or mineral origin; Excipients of synthetic or semisynthetic origin | Low | Supplier awareness of potential COVID-19 risk; Standard duration of transit and hold times |
| Drug Substances | Drug substance of synthetic or semisynthetic origin | Low | Standard duration of transit and hold times |
| Packaging Components | Glass vials, stoppers and seals (Sterile products)Plastic container, heat induction seals and caps (non-sterile products) | Low | Standard duration of transit and hold times; automation of component handling; washing, depyrogenation and sterilization (sterile products) |
| Labeling Materials | Labels and package inserts | Low | Reduce handling during label identification and reconciliation |
| Incoming Potable Water | Ground or surface water | Low | Communication with local water authority |