21 CFR 111.325
§ 111.325 Under this subpart J, what records must you make and keep?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 111.325, § 111.325 Under this subpart J, what records must you make and keep?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84186
- Permanent ID
ys:prov:84186@1- SHA-256
b1bcd9e16fb8521381e95e353be45007de57d374846abc3361d0ad4bfa3d1007
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.