Medical Gases Regulations & Classifications

Guidance on regulations & classifications and cylinder storage and handling for a safer workplace

Medical Gases Regulations & Classifications
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You can depend on receiving top quality gases from BOC Healthcare. All our medical gases are fully compliant with IMB requirements. Our manufacturing sites are audited by the IMB Inspectorate every 2 years. In addition, our Quality Management System is also registered to ISO 9000- 2008 (audited by NSAI).

European Directive 2001/83 is the prime legislation that covers the requirements for the manufacture and supply of medicinal products – which includes the full range of medical gases supplied by BOC Healthcare.

The regulations cover the requirements for licensing the products and defines the use of Good Manufacturing Practice (GMP) to control its manufacture. The regulations are designed to protect patient safety, ensuring that the products are safe, efficacious and of an appropriate quality level.

Medicinal products are classified when licensed to define the control required when supplying the patient, ranging from those products available ‘over the counter’ without a prescription, to those which can only be supplied to under prescription to a named patient.

Pharmaceutical quality

Medical gases are essential to modern medicine and should be considered, prescribed and administered with the same precision and care as any other pharmaceutical products.

The medicinal products supplied by BOC Healthcare are licensed for use by the Irish Medicines Board (IMB) and satisfy the requirements stipulated by the European legislation. BOC were among the first companies to adopt these pharmaceutical standards for medical gases.

In addition to the requirements, for operating to a Quality Management System compliant with the requirements of the EC Good Manufacturing Practice (GMP) guide, the guidelines include detailed requirements for personnel, training, premises and equipment, documentation, production, quality control, storage and release (specifically detailed for medicinal gases through annex 6 of the general GMP guide).

Therefore, for all medical gases supplied, BOC Healthcare can offer to both patients and healthcare professionals a safe, reliable and simple application, meeting all the quality criteria of a registered pharmaceutical product.

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