The quality and integrity of medical gas cylinders and the gases inside can be negatively affected by a lack of adequate controls during the supply chain.
It is therefore essential that companies who store and distribute medical gases hold the relevant qualifications, and meet specific GDP (Good Distribution Practice) requirements outlined by The Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
The high pressure contained within gas cylinder walls can result in a rapid release – causing personal injury and damage to property. When situated in the busy and temperamental environment of hospitals and other medical settings, it is crucial that they have been handled with the sufficient care to minimise the risk to staff, patients and surrounding equipment.
As part of our work on technical Sub Committee 7 – Medical Cases, for the British Compressed Gases Association (BCGA), the AMS Composite Cylinders team contributed to the creation of Guidance Note 32.
Entitled Medical Gases: Good Distribution Practice, this informative document interprets the specific GDP requirements for medical gas products and is intended to be used by the medical gas industry to ensure a consistent approach.
To read the original note in its entirety, please visit: INSERT LINK
Medical Gases: Good Distribution Practice – An Overview
Guidance Note 32 presents information relating to the correct storage, distribution and handling of medical gas cylinders to ensure that suppliers of this product are compliant with the principles of GDP, and are operating within a safe way.
It has been put together for all company and Agent-employed staff involved in the supply of medical gas products to customers from UK facilities, Agent operated stores and medical gas product manufacturing, distribution and storage locations.
- An overview of key terminology and definitions
- An explanation of legislative requirements (including quality management system principles and license requirements)
- A chapter dedicated to GDP responsibilities
- An overview of training and the appropriate premises for medical gas cylinders
- An identification of the best practices in operations
- How to correctly dispose of faulty or recalled products
- An overview of the correct self-inspection and audit procedure
Guidance Note 32 contains important information that has been put together to help keep providers of medical gas cylinders safe and legally compliant with industry standards and regulations.
Key terminology and definitions
In order to understand and comply with specific GDP principles it is necessary to be aware of the key terminology and definitions frequently used and referred to.
This document features a list of some key definitions – explaining what they mean and their relevance to Wholesale Distribution Authorisation (WDA) and GDP.
Legislative Requirements – Why They Matter
GDP is part of the overall Quality Management System, which covers the regulatory requirements for the storage, distribution, and supply of medical gas products to company approved customers. Risk Management is a fundamental principle of this, so there is a clear set of legislative requirements that must be met and adhered to.
Guidance Note 32 covers why such legislative requirements are necessary and lists the relevant license requirements. It also explains the duties of the named Responsible Person and what their role is on a site.
The Importance of Premises
Premises used for the storage and distribution of medical gas products must be secure and of sufficient capacity to allow for safe handling and segregation.
It is imperative for suppliers to know what their legal obligations are regarding this, and what the correct storage arrangements are to ensure that product quality and appearance standards are not compromised.
Guidance Note 32 covers this, and also outlines possible design options for suitable storage facilities.
Operations – An Overview
Poor product management can result in stock waste, damaged or hazardous products and unhappy customers.
Guidance Note 32 explains the correct operations procedures to ensure that medical gas products and the information they carry regarding their identity and status are not adversely affected by transport and storage activities.
Medical Oxygen Cylinders from AMS Composite Cylinders
AMS Composite Cylinders supplies state of the art, lightweight gas cylinders for a wide range of healthcare, homecare, breathing gas and medical gas applications.
We supply clients across the UK, Europe, the Middle East and Latin America, providing industry leading quality, reliable service and short lead times.
Producing cylinders to a wide range of recognised global standards, we hold accreditations in all major markets worldwide. We manufacture to ISO and EN standards (including ISO-11119-2, ISO 11119-1, EN 12245, EN 12257, ISO 7666, ISO 11118 and EN12245) and to the requirements of UN PED/TPED, DOT (USA) and TC (Canada).
For additional information AMS Composite Cylinders, our medical gas cylinders and our accreditations, please contact us today.