[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: 21CFR111.205]

[Page 247-248]
 
                        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.  111.205  What is the requirement to establish a master manufacturing record?


    (a) You must prepare and follow a written master manufacturing 
record for each unique formulation of dietary supplement that you 
manufacture, and for each batch size, to ensure uniformity in the 
finished batch from batch to batch.
    (b) The master manufacturing record must:

[[Page 248]]

    (1) Identify specifications for the 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; and
    (2) Establish controls and procedures to ensure that each batch of 
dietary supplement that you manufacture meets the specifications 
identified in accordance with paragraph (b)(1) of this section.
    (c) You must make and keep master manufacturing records in 
accordance with subpart P of this part.