---
kind: "section"
citation: "21 C.F.R. § 111.303"
title: "21"
number: "111.303"
heading: "What are the requirements under this subpart J for written procedures?"
url: "https://uscodex.org/cfr/21/111.303"
---

# §111.303. What are the requirements under this subpart J for written procedures?


You must establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met.


## 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.