Posted 28 June 2017
By Michael Mezher
The US Food and Drug Administration (FDA) on Wednesday issued a revised draft guidance detailing the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003.
Medical gases are typically regulated as finished pharmaceuticals by FDA and must meet certain GMP requirements. In the late 1990s and 2000s, renewed attention was brought to medical gases after mix-ups where the wrong gas was used to treat a patient led to at least eight deaths between 1996 and 2004.
According to FDA, the revised guidance is expected to reduce the regulatory burden for medical gas manufacturers "by providing clear, up-to-date, detailed recommendations regarding cGMP issues." The guidance is also trimmed down considerably from the earlier version, down to just 28 pages compared to 45 previously.
FDA says it developed the draft guidance after determining that updated guidance would be useful to medical gas manufacturers following a 2015 review of its regulations required under the Food and Drug Administration Safety and Innovation Act (FDASIA). In the review, FDA concluded that its existing regulatory framework is sufficient to regulate medical gases and would only require minor changes, though it noted that updated guidance and inspector training may be warranted.
In the guidance, FDA lays out its expectations for GMP requirements for medical gas manufacturers, including recommendations for quality control systems; buildings and facilities; equipment; production, process, packaging, labeling and laboratory controls; and recommendations for record keeping and reporting.