Risk Assessment—Management of Manufacturing Materials during COVID-19 Pandemic

MaterialsRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
Pharmaceutical ExcipientsExcipients derived from plant, animal, or mineral origin; Excipients of synthetic or semisynthetic originLowSupplier awareness of potential COVID-19 risk; Standard duration of transit and hold times
Drug SubstancesDrug substance of synthetic or semisynthetic originLowStandard duration of transit and hold times
Packaging ComponentsGlass vials, stoppers and seals (Sterile products)Plastic container, heat induction seals and caps (non-sterile products)LowStandard duration of transit and hold times; automation of component handling; washing, depyrogenation and sterilization (sterile products)
Labeling MaterialsLabels and package insertsLowReduce handling during label identification and reconciliation
Incoming Potable WaterGround or surface waterLowCommunication with local water authority