[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: 21CFR111.105]

[Page 242]
 
                        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.  111.105  What must quality control personnel do?

    Quality control personnel must ensure that your manufacturing, 
packaging, labeling, and holding operations ensure the quality of the 
dietary supplement and that the dietary supplement is packaged and 
labeled as specified in the master manufacturing record. To do so, 
quality control personnel must perform operations that include:
    (a) Approving or rejecting all processes, specifications, written 
procedures, controls, tests, and examinations, and deviations from or 
modifications to them, that may affect the identity, purity, strength, 
or composition of a dietary supplement;
    (b) Reviewing and approving the documentation setting forth the 
basis for qualification of any supplier;
    (c) Reviewing and approving the documentation setting forth the 
basis for why meeting in-process specifications, in combination with 
meeting component specifications, will help ensure that the identity, 
purity, strength, and composition of the dietary supplement are met;
    (d) Reviewing and approving the documentation setting forth the 
basis for why the results of appropriate tests or examinations for each 
product specification selected under Sec.  111.75(c)(1) will ensure that 
the finished batch of the dietary supplement meets product 
specifications;
    (e) Reviewing and approving the basis and the documentation for why 
any product specification is exempted from the verification requirements 
in Sec.  111.75(c)(1), and for why any component and in-process testing, 
examination, or monitoring, or other methods will ensure that such 
exempted product specification is met without verification through 
periodic testing of the finished batch;
    (f) Ensuring that required representative samples are collected;
    (g) Ensuring that required reserve samples are collected and held;
    (h) Determining whether all specifications established under Sec.  
111.70(a) are met; and
    (i) Performing other operations required under this subpart.