part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "I"
subpart_subject: "Production and Process Control System: Requirements for the Batch Production Record"
section_number: "111.255"
section_subject: "What is the requirement to establish a batch production record?"
cfr_reference: "21 CFR 111.255"
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 a batch production record every time you manufacture a batch of a dietary supplement;
(b)Your batch production record must include complete information relating to the production and control of each batch;
(c)Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and
(d)You must make and keep batch production records in accordance with subpart P of this part.