specification
- Guideline or reference source
- ICHQ6A Specifications: new chemical drug substances and products
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. "Conformance to specifications" means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.
- Narrower Term
- specification, release
- specification, shelf life
- Related Term
- acceptance criteria
- analytical procedure
- re-test date
- significant change
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