[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: 21CFR111.123]

[Page 243-244]
 
                        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.  111.123  What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?

    (a) Quality control operations for the master manufacturing record, 
the batch production record, and manufacturing operations must include:
    (1) Reviewing and approving all master manufacturing records and all

[[Page 244]]

modifications to the master manufacturing records;
    (2) Reviewing and approving all batch production-related records;
    (3) Reviewing all monitoring required under subpart E;
    (4) Conducting any required material review and making any required 
disposition decision;
    (5) Approving or rejecting any reprocessing;
    (6) Determining whether all in-process specifications established in 
accordance with Sec.  111.70(c) are met;
    (7) Determining whether each finished batch conforms to product 
specifications established in accordance with Sec.  111.70(e); and
    (8) Approving and releasing, or rejecting, each finished batch for 
distribution, including any reprocessed finished batch.
    (b) Quality control personnel must not approve and release for 
distribution:
    (1) Any batch of dietary supplement for which any component in the 
batch does not meet its identity specification;
    (2) Any batch of dietary supplement, including any reprocessed 
batch, that does not meet all product specifications established in 
accordance with Sec.  111.70(e);
    (3) Any batch of dietary supplement, including any reprocessed 
batch, that has not been manufactured, packaged, labeled, and held under 
conditions to prevent adulteration under section 402(a)(1), (a)(2), 
(a)(3), and (a)(4) of the act; and
    (4) Any product received from a supplier for packaging or labeling 
as a dietary supplement (and for distribution rather than for return to 
the supplier) for which sufficient assurance is not provided to 
adequately identify the product and to determine that the product is 
consistent with your purchase order.