sterile product
- Guideline or reference source
- FDASDP Sterile drug products produced by asceptic processing - CGMP
- Definition
- For purposes of this guidance, sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product.
- Broader Term
- sterile
- Related Term
- aseptic process
- sterility
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