FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003.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.
The medical gas industry is expected to continue to grow at a CAGR of 8% over the next several years. Given the potential growth of the market, Nugent believes the timing is right for FDA to clarify its position to device developers. The global medical gas equipment market share was dominated by Air Liquide and Linde Gas in 2015. These two companies account for 38% of industry revenue. The rest of the market includes larger chemical and gas supply companies.
The essential goal of the guidance, according to Nugent, is to clarify language of the quality control systems, the building and facilities production processes, labeling, and laboratory controls. They also include recommendations on reporting and record keeping.
“These manufacturers need to look at their quality department as the principle group that’s going to manage the medical gas,” Nugent said. “Testing alone can’t ensure product quality.”
Nugent said the quality control units within companies will need to monitor and implement governance over systems for managing medical gases, such as containers, closures, materials, packaging, and labeling.
“FDA is really leaning on the quality group to take responsibility and given them the authority to approve and reject the compounds.”
When FDA comes into a facility, it will look to ensure those quality controls are in place, along with written procedures to explain both the device systems and supply chain management.
“They will want to know how quality is interacting with production on the floor, and what the design controls are in place.”
The other part of FDA guidance outlines the need to collaborate with suppliers. Supply partners who provide the gas or mix the gases must be part of the collaboration. However, as Nugent put it: “The authorities are looking at finished product, they’re not looking about who made it or whose problem it is. They’re looking at the last person, the manufacturer, who made the product. If anything goes wrong, they’re being held accountable.”
For the most part, Nugent says manufacturers already have some part of the system in place to meet these new expectations.
“They likely have some automated processes in place, however, companies might need to consider automating the procedures globally, across all their enterprise facilities.” Nugent noted that fully automated systems can manage product quality and regulatory systems.
With the new guidance, said Nugent, FDA spells out that the medical supply company is legally liable for patient safety. “If you haven’t already, it’s time to automate.”