Risk Assessment—Representative Sterile Drug Products (Liquid-filled Stoppered Glass Vials) during COVID-19 Pandemic

Manufacturing ProcessRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
Incoming material sampling and testingSampling is an invasive process in a warehouseModerateSampling booths and personal protective equipment (PPE)
WarehousingLimited environmental controlLowImproved environmental control (IEC)
Ingredient weighingWeighing is a labor-intensive processLow to ModerateEvaluate weighing booths and PPE
Bulk solution preparationSolution preparation is a potentially invasive processLow to ModerateUse of Restricted Access Barrier Systems (RABS) and isolators
Packaging component preparationComponent loading and unloading is a potentially invasive processLowAutomation of component handling; Depyrogenation and sterilization of vials and stoppers
Sterile filtration and aseptic filling and SealingAseptic processing is a potentially invasive processLowUse of RABS and isolators
Visual inspectionInspection is an invasive processLowHandling automation; IEC; PPE
Packaging and labelingPackaging is an invasive processLowHandling automation;IEC; PPE