acceptance criteria
- Guideline or reference source
- ICHQ6A Specifications: new chemical drug substances and products
- ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- Numerical limits, ranges or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet.
- Used For
- acceptance criterion
- Narrower Term
- acceptance criteria for software
- acceptance criteria for specimens
- pre-determined acceptance criteria
- shelf life acceptance criteria
- Related Term
- analytical procedure
- specification
- specification, release
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