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Code · CFR · Title 21 — Food and Drugs · Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals · § 211.115

§ 211.115. Reprocessing.

59 words·~1 min read·/us/cfr/t21/s§ 211.115·

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(a)Written procedures shall be established and followed prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics.
(b)Reprocessing shall not be performed without the review and approval of the quality control unit.
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