Storage of Non-Sterile HDs and APIs

This SOP establishes the requirements for storing non-sterile hazardous drugs (HDs) and active pharmaceutical ingredients (APIs)—including segregation of inventory, temperature and humidity controls, use of externally vented negative pressure rooms with at least 12 ACPH, dedicated refrigeration/freezers, surface requirements, and disaster preparedness precautions—to ensure product integrity, personnel safety, and compliance with USP <800>.

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