---
kind: "section"
citation: "21 C.F.R. § 213.110"
title: "21"
number: "213.110"
heading: "Sampling and testing of in-process materials."
url: "https://uscodex.org/cfr/21/213.110"
---

# §213.110. Sampling and testing of in-process materials.

- (a) In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality unit during the production process.
- (b) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes.
- (c) Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374.

### Source

Source: 89 FR 51770, June 18, 2024, unless otherwise noted.