specification, shelf life
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug substance throughout its re-test period, or that a drug product should meet throughout its shelf life.
- Broader Term
- specification
- Related Term
- shelf life
- shelf life acceptance criteria
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