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Code · CFR · Title 21 — Food and Drugs · Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals · § 211.87

§ 211.87. Retesting of approved components, drug product containers, and closures.

61 words·~1 min read·/us/cfr/t21/s§ 211.87·

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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.
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