In the heavily regulated medical gases industry, every organisation has an obligation to take quality management seriously.

Every organisation involved with the manufacture of medical gases must comply with the basic principles and practices of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). GMP and GDP are part of the overall Quality Management System (QMS) – which covers all the regulatory requirements for the storage, distribution and supply of products.

When companies fall short of the required standards – they need to address these, by implementing corrective and preventative actions (CAPA).

As part of our work on Technical Sub Committee 7 – Medical Gases, for the British Compressed Gases Association (BCGA), our team was involved in the creation of Guidance Note 40: Medical Gases – Quality Management Systems Corrective and Preventative Actions. This provides guidance on the different CAPA for manufacturers of medical gases.

You can read Guidance Note 40 in full here.

Guidance Note 40 – An Overview

The guidance document is designed to help manufacturers of medicinal and medical device gases to incorporate the principles of corrective and preventative actions (CAPA) into their risk management process.

It covers:

  • Identifying non-conformities and non-fulfilments of requirements
  • Risk assessment of non-conformities
  • Measurement, analysis and improvement processes
  • Identifying corrective actions
  • Customer complaints
  • Auditing, self-assessment and inspection
  • Identifying preventive actions
  • Corrective and preventive action planning

Corrective and Preventative Actions in Medical Gases

There are three main ways of identifying issues that require corrective action:

  • Customer complaints
  • Auditing, self-assessment and inspections
  • Internal personal discovery

Customer complaints

Customer complaints are usually related to one or more of the following:

  • Valves (leaks, unable to open, flow rate)
  • Documentation (certificates or patient info leaflets)
  • Condition (painting, labelling, or cleanliness of cylinder)
  • Quantity (insufficient pressure in cylinder)
  • Adverse reactions to products

Corrective actions might include returning cylinders to the manufacturer for investigation, reviewing internal processes and controls, liaising with the customer to ensure the correct documentation is provided, conducting internal training and taking steps to identify and contain product.

Auditing, self-assessment and inspections

Deficiencies identified via audits, self-assessment or inspection include:

  • Documentation issues
  • Failure to follow processes and procedures
  • Data recording
  • Competence of personnel

Corrective actions might include reviewing, revising and reissuing documentation, reviewing the competence of staff and providing additional training, reviewing maintenance and calibration, recalling products and notifying the medical authorities.

Internal non-conformities raised by personnel

Personnel may identify the following defects and deficiencies:

  • Valves (leaks, unable to open, flow rate)
  • Documentation (certificates or patient info leaflets)
  • Condition (painting, labelling, or cleanliness of cylinder)
  • Quantity (insufficient pressure in cylinder)
  • Failed batches of product

Internal non-conformities should be investigated to identify causes and determine the appropriate corrective actions.

CAPA at AMS Composite Cylinders

At AMS Composite Cylinders, we believe strongly in the importance of quality management, and are continuously looking for ways to improve the quality of our service. As part of this, we utilise a process informed by the CAPA framework outlined in this Guidance Note as part of risk management.

Whenever we receive feedback from customers, internal audits or our own team, we undertake a full investigation to ensure that we identify the issue, and implement systems to mitigate the chances of this happening in the future.

Medical Oxygen Cylinders from AMS Composite Cylinders

AMS Composite Cylinders supplies state of the art, lightweight aluminium and carbon composite 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 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.