[ HOW-TO GUIDE ]
How to Rebase Medical Gas CGMP on Part 213
Move a medical gas operation’s procedures from Part 211 to Part 213 and close the gaps the new part names.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Since 18 December 2025, medical gases have their own CGMP part, and Part 211 no longer applies to them. Most firms’ procedures, quality agreements and batch records still cite Part 211. The work is a section-by-section rebase on Part 213, followed by the receipt, container and reporting controls written for gases.
- 1
Inventory every document that cites Part 211
List procedures, quality agreements, batch record templates, training material and specifications that cite Part 211 or its sections. Each one either moves to the matching Part 213 section, is rewritten where the gas provision differs, or is retired where the provision does not carry over.
- 2
Map section by section, not by title
Part 213 follows Part 211’s numbering in most places, but some provisions are adapted to sealed gas systems, such as equipment cleaning, and some are left out, such as time limitations on production. Record for each procedure which section it now implements and what changed.
- 3
Rebuild receipt of incoming gases
For each incoming designated medical gas, decide between full compendial testing and certificate-of-analysis verification, check that certificates carry every element §213.82(a)(1) lists, set up the supplier-reliability programme §213.82(a)(2) requires, and make the identity test on receipt part of the procedure.
- 4
Check containers and connections
Confirm container and closure specifications, testing and cleaning methods are written (213.94(d)), and that portable cryogenic containers have gas-specific use outlet connections that cannot readily be removed except by the manufacturer (213.94(e)(1)).
- 5
Confirm release testing and records
Make sure every batch has a laboratory determination of conformance to final specifications, including identity and strength, before release (213.165), with validated methods verified under actual conditions of use.
- 6
Set up Part 230 reporting
For designated medical gases, put the 45-day and 3-working-day field alert clocks (230.205), the 15-day ICSR clock (230.220), the 30-day certification supplement (230.70) and the annual report within 60 days of the new year (230.80) into the procedures and the calendar.
- !Replacing “211” with “213” in every document without checking whether the provision changed.
- !Accepting certificates of analysis without the supplier-reliability programme behind them.
- !Skipping the identity test on receipt because a certificate is on file.
- !Treating field alert timing as the general drug clock rather than the clocks Part 230 sets for designated medical gases.
How to Rebase Medical Gas CGMP on Part 213: frequently asked questions
Common questions on rebase medical gas cgmp on part 213.
Do we need to revalidate everything?
Not because of the renumbering alone. Validation evidence stays valid where the process has not changed; the rebase is a documentation and gap-closure exercise unless a gap requires a process change.
Which part covers certification and adverse event reporting?
Part 230, published in the same rule as Part 213, for designated medical gases.
What if a provision of Part 211 we followed is not in Part 213?
Record it as not required by Part 213 and decide whether to keep it as good practice. Removing a control is a change and goes through change control.
WHERE NEXT
- DO ITOpen the Medical Gas Part 213 Gap Assessment template →The structure these steps fill in.
- UNDERSTAND ITMedical Gases: CGMP, Certification and Reporting →The principles behind the procedure.
- ALL GUIDESBrowse all 127 how-to guides →
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