[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: 21CFR111.80]

[Page 240]
 
                        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 E_Requirement to Establish a Production and Process Control 
                                 System
 
Sec.  111.80  What representative samples must you collect?

    The representative samples that you must collect include:
    (a) Representative samples of each unique lot of components, 
packaging, and labels that you use to determine whether the components, 
packaging, and labels meet specifications established in accordance with 
Sec.  111.70(b) and (d), and as applicable, Sec.  111.70(a) (and, when 
you receive components, packaging, or labels from a supplier, 
representative samples of each unique shipment, and of each unique lot 
within each unique shipment);
    (b) Representative samples of in-process materials for each 
manufactured batch at points, steps, or stages, in the manufacturing 
process as specified in the master manufacturing record where control is 
necessary to ensure the identity, purity, strength, and composition of 
dietary supplements to determine whether the in-process materials meet 
specifications established in accordance with Sec.  111.70(c), and as 
applicable, Sec.  111.70(a);
    (c) Representative samples of a subset of finished batches of each 
dietary supplement that you manufacture, which you identify through a 
sound statistical sampling plan (or otherwise every finished batch), 
before releasing for distribution to verify that the finished batch of 
dietary supplement meets product specifications established in 
accordance with Sec.  111.70(e), and as applicable, Sec.  111.70(a);
    (d) Representative samples of each unique shipment, and of each 
unique lot within each unique shipment, of product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier) to determine whether the 
received product meets specifications established in accordance with 
Sec.  111.70(f), and as applicable, Sec.  111.70(a); and
    (e) Representative samples of each lot of packaged and labeled 
dietary supplements to determine whether the packaging and labeling of 
the finished packaged and labeled dietary supplements meet 
specifications established in accordance with Sec.  111.70(g), and as 
applicable, Sec.  111.70(a).

[[Page 241]]