Risk Assessment—Testing of Incoming Pharmaceutical Ingredients, Packaging Components, Intermediates, and Finished Products during COVID-19 Pandemic
| Materials—Sampling and Testing | Risk Identification | Risk Rating | Risk Mitigation/Critical Process Controls |
|---|---|---|---|
| Sampling of incoming materials | Human intervention; Limited environmental controls in warehouses | Moderate | Personal protective equipment; sampling booths; labeling sampled containers |
| Transportation to the testing area | Transition through the facility | Low | Disinfection of the surface of containers, drums, shrink-wrap, and pallets |
| Sample testing | Personnel handling | Low | Personal protective equipment; limited access to testing area; environmental controls |
| Sample disposition | Disposal | Low | Controlled destruction of samples |