Risk Assessment—Testing of Incoming Pharmaceutical Ingredients, Packaging Components, Intermediates, and Finished Products during COVID-19 Pandemic

Materials—Sampling and TestingRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
Sampling of incoming materialsHuman intervention; Limited environmental controls in warehousesModeratePersonal protective equipment; sampling booths; labeling sampled containers
Transportation to the testing areaTransition through the facilityLowDisinfection of the surface of containers, drums, shrink-wrap, and pallets
Sample testingPersonnel handlingLowPersonal protective equipment; limited access to testing area; environmental controls
Sample dispositionDisposalLowControlled destruction of samples