ABSTRACT
A specifi cation is defi ned as a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described (1). As such, a specifi cation defi nes a quality standard to confi rm the quality of products and establishes the set of criteria to which a drug substance, drug product, or materials at other stages of its manufacture should conform in order to be considered acceptable for its intended use (2). “Conformance to specifi cation” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifi cations are critical quality “standards” that are proposed and justifi ed by the manufacturer and approved by regulatory authorities as conditions of approval. Specifi cations not only apply at the release of drug substances and drug products, but are also required as part of stability studies that occur during product development (to assure material used in the clinic remains safe and effi cacious for the lifetime of the studies) as well as ongoing annual stability studies that are required post-approval.
