FDA’s medical gas guidance offers clarity to manufacturers

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By Heather Thompson, September, 2017

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003.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.

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