Risk Assessment—Representative Non-Sterile Drug Product (Compressed Tablet) during COVID-19 Pandemic

Manufacturing ProcessRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
Incoming material sampling and testingSampling is an invasive processModerateSampling booths; Personal protective equipment (PPE)
WarehousingLimited environmental controlLowImproved environmental control
Ingredient weighingWeighing is an invasive processLow to ModerateEvaluate weighing booths and PPE
Excipient size reductionEquipment cleaningLowUpgrade COP and CIP operations
BlendingEquipment cleaningLowUpgrade COP and CIP operations
Granulation— Dry Granulation—WetEquipment cleaningLowUpgrade COP and CIP operations
CompressionEquipment cleaningLowUpgrade COP and CIP operations
Bulk Tablet StorageNoneLowNone
Packaging and labelingPackaging operations are labor intensiveLow to ModerateEvaluate HVAC Systems; Automation of component handling; PPE
Finished goods warehousingPoor environmental controlLowImproved environmental control
ShippingLack of chain of custodyLowDedicated carriers
  • Clean Out-of-Place (COP) and Clean In-Place (CIP).