Under this subpart J, what records must you make and keep?
21 C.F.R. § 111.325
in effectEffective: 2024-07-01(a) You must make and keep records required under this subpart J in accordance with subpart P of this part.
(b) You must make and keep the following records:
(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026