---
kind: "section"
citation: "21 C.F.R. § 111.325"
title: "21"
number: "111.325"
heading: "Under this subpart J, what records must you make and keep?"
url: "https://uscodex.org/cfr/21/111.325"
---

# §111.325. Under this subpart J, what records must you make and keep?

- (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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.