Conformance to specifications definition
Conformance to specifications means that the API and/or FPP, 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.
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.
Conformance to specifications means that the API and / or FPP, when tested according to the