[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.113]

[Page 243]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control
 
Sec.  111.113  What quality control operations are required for a material review and disposition decision?

    (a) Quality control personnel must conduct a material review and 
make a disposition decision if:
    (1) A specification established in accordance with Sec.  111.70 is 
not met;
    (2) A batch deviates from the master manufacturing record, including 
when any step established in the master manufacturing record is not 
completed and including any deviation from specifications;
    (3) There is any unanticipated occurrence during the manufacturing 
operations that adulterates or may lead to adulteration of the 
component, dietary supplement, or packaging, or could lead to the use of 
a label not specified in the master manufacturing record;
    (4) Calibration of an instrument or control suggests a problem that 
may have resulted in a failure to ensure the quality of a batch or 
batches of a dietary supplement; or
    (5) A dietary supplement is returned.
    (b)(1) When there is a deviation or unanticipated occurrence during 
the production and in-process control system that results in or could 
lead to adulteration of a component, dietary supplement, or packaging, 
or could lead to the use of a label not specified in the master 
manufacturing record, quality control personnel must reject the 
component, dietary supplement, packaging, or label unless it approves a 
treatment, an in-process adjustment, or reprocessing to correct the 
applicable deviation or occurrence.
    (2) When a specification established in accordance with Sec.  111.70 
is not met, quality control personnel must reject the component, dietary 
supplement, package or label, unless quality control personnel approve a 
treatment, an in-process adjustment, or reprocessing, as permitted in 
Sec.  111.77.
    (c) The person who conducts a material review and makes the 
disposition decision must, at the time of performance, document that 
material review and disposition decision.