part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "H"
subpart_subject: "Production and Process Control System: Requirements for the Master Manufacturing Record"
section_number: "111.205"
section_subject: "What is the requirement to establish a master manufacturing record?"
cfr_reference: "21 CFR 111.205"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 100 to 169"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.
(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.