After a relatively inactive two years where these gases are concerned, the Food and Drug Administration (FDA) is again focusing its attention on medical gas requirements.
Twenty years ago, the vast majority of bulk medical gas systems (BMGS) were installed at large hospitals. It was a simplistic supply chain as these systems received product shipments directly from the air separation unit...
Ten years ago, the Food and Drug Administration (FDA) did an about-face in their approach to electronic records and signatures to encourage a broader adoption of new record management technologies.
Since our last report on food safety (“The FDA Revises Proposed Rules for Food Safety,” CryoGas International, December 2014, pp. 48-49), activities related to food safety have continued their rapid evolution.
In 2010, the US Federal Drug Administration (FDA) revolutionized how drug manufacturers registered their facilities and listed their products.
Over the last few years B&R Compliance (brcompliance.com) has been providing CryoGas International subscribers with periodic status reports on the impending changes to FDA regulations related to the processing and packaging of foods. We have been predicting the FDA...
A predominant element of the corporate culture of global manufacturing firms, which include the major industrial and medical gas manufacturers, is an integrated safety and risk management program that forms a core element of their management philosophy. These companies religiously adhere...
Over the last 12 months the US Food and Drug Administration (FDA) has been stepping up their audit activity, including at medical gas facilities. B&R Compliance (br compliance.com) offers clients an analysis of the kinds of questions FDA inspectors are asking,...
