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[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.115]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F – Production and Process Controls
Sec. 211.115 Reprocessing.
(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.
As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.
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