21 CFR § 213.186 - Master production and control records.

---
identifier: "/us/cfr/t21/s213.186"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 213.186 - Master production and control records."
title_number: 21
title_name: "Food and Drugs"
section_number: "213.186"
section_name: "Master production and control records."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "213"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374."
regulatory_source: "89 FR 51770, June 18, 2024, unless otherwise noted."
cfr_part: "213"
---


# 213.186 Master production and control records.

(a) To assure uniformity from batch to batch, master production and control records for each medical gas shall be prepared, dated, and signed. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed.

(b) Master production and control records shall include:

(1) The name and strength of the medical gas;

(2) A complete list of components and any incoming designated medical gases used in manufacturing designated by names or codes sufficiently specific to indicate any special quality characteristic;

(3) A description of the medical gas containers and closures, packaging materials, and labels; and

(4) Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.