2. 1
OUTLINE Introduction
Production and Packaging
Storage & Distribution
Batch Tracking
Recalls
Conclusion
3. 2
Introduction
Traceability of medicinal gases refers to the ability to
accurately track and document the movement of these
gases from their production or acquisition through to
their use in patient care.
This process is crucial for ensuring patient safety,
quality control, regulatory compliance, and
accountability throughout the healthcare system.
The data recorded should allow efficient investigation in
case an incident occurs and should allow recalls of
4. 3
Traceability begins with the production of medicinal
gases.
Manufacturers must maintain detailed records of the
production process, including quality control measures,
source materials, and any relevant certifications or
testing.
In the case of packaged medicinal gases, the
packaging components (shells & valves) are reusable.
It is necessary to record additional information, in
Production & Packaging
5. 4
Sells are individually identified. The date of the last
hydrostatic pressure test should be recorded.
Valves are individually identified. Mostly have only a
serial number corresponding to a group of valves.
Valves are also submitted to periodic preventive
maintenance operations.
In terms of risk, more serious incidents have been
reported with cylinders having this type of valve.
… Production & Packaging
6. 5
For simple valves, the type of valve should be
recorded, the name of the manufacturer and the serial
number, if one is available.
For integrated valves, traceability should be ensured for
each valve. Records should include in particular the
type of integrated valve (including the version), the
individual identification reference of the valve, the name
of the manufacturer, the date of the last (or next)
preventive maintenance and details of any preventive
… Production & Packaging
7. 6
Storage & Distribution
Healthcare facilities must maintain accurate records of
their medicinal gas inventory, including quantities on
hand, expiration dates, and batch numbers. This helps
prevent stockouts and ensure that expired or recalled
gases are not used on patients.
During transportation, it's essential to maintain
traceability to ensure that gases are handled properly
and remain within the appropriate temperature and
pressure ranges. Records should include information
8. 7
Batch Tracking
In practice, depending on the scale of operation it may
be difficult to ensure effective traceability without a
computerised system.
Use of bar codes or electronic chips on the cylinders
may facilitate this.
Any computerised system used to ensure traceability
should conform to the requirements of Annex 11 of the
EU GMP Guide.
9. 8
Recalls
The manufacturer of a medicinal gas receive a serious
complaint relating to the quality of the medicinal gas
itself or the packaging components, the system in place
should allow the identification of the affected cylinders
and, where necessary, the recall of any affected
cylinders from the market place.
A defect relating to packaging components may require
identification of specific cylinders within a finished
product batch or identification of cylinders present in a
10. 9
Conclusion
Traceability is essential for ensuring the safety, efficacy,
and quality of medicinal gases throughout the
healthcare supply chain.
By maintaining accurate records and tracking the
movement of gases from production to patient care,
healthcare stakeholders can enhance patient safety,
comply with regulatory requirements, and mitigate risks
associated with the use of these critical therapeutic
agents.
