FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory framework.
Colleen Nugent said the guidance applies to those manufacturers who provide the gas mixtures in a drug-delivery mechanism, such as high pressure cylinders. Nugent is Product Manager at Sparta Systems, a quality management software provider for major pharmaceutical companies across the globe.
Gasses used in medical applications include oxygen, carbon dioxide, nitrogen, nitrogen oxide, medical air, and helium. They are typically regulated as finished pharmaceuticals by FDA and are expected to meet certain GMP requirements.
However, Nugent said it’s critical to understand how the new guidance will impact the players across the gas and the various delivery manufacturers.
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