RECORDREFERENCE OUTLINE

Medical Gas Part 213 Gap Assessment

Assessment that moves a medical gas operation from Part 211 to Part 213: the documents that still cite Part 211 and where each now maps, the Part 213 controls from the quality unit to receipt, containers and release, the Part 230 reporting clocks for designated medical gases, and an action plan routed through change control.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

Checking your access…

HOW TO FILL THIS IN
How to Rebase Medical Gas CGMP on Part 213, step by step →
REGULATIONS MAPPED
21 CFR Part 21321 CFR Part 23021 CFR Part 211
DOCUMENT TYPE
Record
LAST UPDATED
October 2026
PURPOSE

The record of a medical gas operation’s move onto 21 CFR Part 213, which has applied to medical gases since 18 December 2025 while Part 211 no longer does. It maps every document that still cites Part 211, checks the Part 213 controls written for gases, and, for designated medical gases, the Part 230 reporting clocks.

What's Inside

✓The operation, its gases and the certifications it holds
✓A map from each Part 211 citation to its Part 213 section
✓The Part 213 controls, with current procedure, gap and owner
✓The Part 230 obligations for designated medical gases
✓An action plan tied to change control

How to Use It

1Record the activities and gases first; the Part 230 section applies only to designated medical gases.
2List every document that cites Part 211 before judging any gap.
3For each Part 213 control, name the procedure that meets it or record the gap.
4Send each gap to change control, including removal of any control Part 213 no longer requires.
5Check certificate-of-analysis practice against the seven elements §213.82(a)(1) lists, and confirm the identity test on receipt is performed whether or not a certificate is relied on.
6Put each Part 230 clock into the complaint-handling and regulatory calendar with a named owner, and test it with a recent complaint or change.
7Repeat the assessment when activities, gases or certifications change.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Operation and Scope
2Documents Citing Part 211
3Part 213 Controls
4Part 230 Obligations
5Action Plan
AAppendix A — Approval
REGULATORY CONTEXT

21 CFR 211.1(a) excludes medical gases from Part 211. 21 CFR Part 213 sets their CGMP, including the quality unit (213.22), receipt of incoming designated medical gases (213.82), containers and closures (213.94) and release testing (213.165). 21 CFR Part 230 sets certification and postmarketing reporting for designated medical gases, including field alert reports (230.205) and ICSRs (230.220), supplements within 30 calendar days of a change (230.70) and an annual report within 60 calendar days of each new year (230.80).

MAPPED STANDARDS
21 CFR Part 21321 CFR Part 23021 CFR Part 211
Browse the standards catalog →

WHERE NEXT

  1. FILL IT INHow to Rebase Medical Gas CGMP on Part 213 →The procedure this template records, one step at a time.
  2. ALL TEMPLATESBrowse all 122 templates →

A free account keeps what you save, remembers where you are across devices, and can send you the weekly regulatory briefing. Create a free account