Component Handling, Spill, and Disposal (Sterile Compounding)

This SOP establishes the requirements for handling, storing, and disposing of sterile compounding components—including inspection and verification before use, proper storage conditions with monitoring, prevention of contamination or mix-ups, documentation and quarantine of rejected components, spill management with trained personnel and spill kits, and disposal through reverse distributors—to ensure safety, product integrity, and compliance with USP <797>.

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