GMP - Traceability of Medicinal Gases.pptx

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1. OF MEDICINAL GASES Traceability

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 defective products.

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 particular in relation to the use and maintenance of these components. 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 maintenance performed on the valve. … 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 on the transport route, handling procedures, and any deviations from standard protocols.

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 number of finished product batches in order to establish the extent of any recall.

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.

11. BY Hossam Khayyal PSAU NO. 445620004 THANK YOU