21 C.F.R. § 211.115 Reprocessing.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F—Production and Process Controls
§ 211.115 Reprocessing.
