21 C.F.R. § 211.87

Current through September 30, 2024
Section 211.87 - Retesting of approved components, drug product containers, and closures

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 § 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.

21 C.F.R. §211.87