[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: 21CFR111.210]

[Page 248]
 
                        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 H_Production and Process Control System: Requirements for the 
                       Master Manufacturing Record
 
Sec.  111.210  What must the master manufacturing record include?

    The master manufacturing record must include:
    (a) The name of the dietary supplement to be manufactured and the 
strength, concentration, weight, or measure of each dietary ingredient 
for each batch size;
    (b) A complete list of components to be used;
    (c) An accurate statement of the weight or measure of each component 
to be used;
    (d) The identity and weight or measure of each dietary ingredient 
that will be declared on the Supplement Facts label and the identity of 
each ingredient that will be declared on the ingredients list of the 
dietary supplement;
    (e) A statement of any intentional overage amount of a dietary 
ingredient;
    (f) A statement of theoretical yield of a manufactured dietary 
supplement expected at each point, step, or stage of the manufacturing 
process where control is needed to ensure the quality of the dietary 
supplement, and the expected yield when you finish manufacturing the 
dietary supplement, including the maximum and minimum percentages of 
theoretical yield beyond which a deviation investigation of a batch is 
necessary and material review is conducted and disposition decision is 
made;
    (g) A description of packaging and a representative label, or a 
cross-reference to the physical location of the actual or representative 
label;
    (h) Written instructions, including the following:
    (1) Specifications for each point, step, or stage in the 
manufacturing process where control is necessary to ensure the quality 
of the dietary supplement and that the dietary supplement is packaged 
and labeled as specified in the master manufacturing record;
    (2) Procedures for sampling and a cross-reference to procedures for 
tests or examinations;
    (3) Specific actions necessary to perform and verify points, steps, 
or stages in the manufacturing process where control is necessary to 
ensure the quality of the dietary supplement and that the dietary 
supplement is packaged and labeled as specified in the master 
manufacturing record.
    (i) Such specific actions must include verifying the weight or 
measure of any component and verifying the addition of any component; 
and
    (ii) For manual operations, such specific actions must include:
    (A) One person weighing or measuring a component and another person 
verifying the weight or measure; and
    (B) One person adding the component and another person verifying the 
addition.
    (4) Special notations and precautions to be followed; and
    (5) Corrective action plans for use when a specification is not met.