Gas process validation guidelines from the FDA have changed significantly. Now is the time to get to grips with new validation expectations for your medical gas equipment, says Ron Ball.
The FDA published a revised guidance document covering process validation in January of 2011. The content of this publication is driving an evolution in how validation protocols are developed and executed throughout the pharmaceutical industry, even within the medical gas industry. Under FDA’s latest thinking validation is transitioning from an activity performed only once or infrequently such as when process changes occur, into an on-going activity that needs to be pro-actively managed on a routine basis. This article will look at how this is changing expectations for validation in the gases industry.
Validation – why & what
When it comes to explaining why firms must validate, that is relatively easy – the law says so. The FDA routinely cites section 501(a)(2)(B) of the Food Drug and Cosmetic act as the foundational authority for validation. It further cites sections of 21 CFR, specifically section 211.110(a) as additional authority for validation requirements. The section of the regulation the FDA cites simply states that firms are responsible to: “…monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of the process material and drug product…” This is one of the very few references to process validation anywhere in 21 CFR. From this singular reference we are left to interpret what kind of medical gas fill systems are required to be validated, which is significantly more difficult.
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