Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 211  /  Sec. 211.87 Retesting of approved components, drug product containers,

Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with Sec. 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the component, drug product container, or closure.