---
kind: "section"
citation: "21 C.F.R. § 213.189"
title: "21"
number: "213.189"
heading: "Batch production and control records."
url: "https://uscodex.org/cfr/21/213.189"
---

# §213.189. Batch production and control records.

- (a) Batch production and control records shall be prepared for each batch of medical gas produced.
- (b) These records shall include documentation that each significant step in the manufacture, processing, packing, or holding of the medical gas produced was accomplished, including:
  - (1) Dates of each significant step, including in-process and laboratory tests as applicable;
  - (2) A description of the container for the medical gas, including the number and size of the containers filled as applicable;
  - (3) Specific identification of each component and its source or in-process material used as applicable;
  - (4) Measures of components used in the course of processing as applicable;
  - (5) Testing results, including any in-process test results and finished product test results;
  - (6) Dated signature or initials of the persons performing and directly supervising or checking each significant step in the operation;
  - (7) Inspection of the packaging and labeling area before and after use;
  - (8) Complete labeling control records, including specimens or copies of all labeling used and label application and reconciliation records as appropriate; and
  - (9) Any investigation made according to [§ 213.192](/cfr/21/213.192.md).

## 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.