[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.115]

[Page 124]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
               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.