part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "J"
subpart_subject: "Production and Process Control System: Requirements for Laboratory Operations"
section_number: "111.325"
section_subject: "Under this subpart J, what records must you make and keep?"
cfr_reference: "21 CFR 111.325"
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 make and keep records required under this subpart J in accordance with subpart P of this part.
(1)Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;
(2)Documentation that laboratory methodology established in accordance with this subpart J is followed.
(i)The person who conducts the testing and examination must document, at the time of performance, that laboratory methodology established in accordance with this subpart J is followed.
(ii)The documentation for laboratory tests and examinations must include the results of the testing and examination.