A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance should conform to be considered acceptable for its intended use.
Conformance to specifications means that the drug substance, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.
Specifications are binding quality standards that are agreed to between the appropriate governmental regulatory agency and the applicant.
(ICH draft guidance Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances) »More terms