ComplianceOnline

Current Good Manufacturing Practice for Medical Gases

  • By: Staff Editor
  • Date: February 14, 2017
Abstract:

Current Good Manufacturing Practice for Medical Gases

The FDA recently amended its CGMP (current good manufacturing practice) and labeling regulations for medical gases. The agency requires that portable cryogenic medical gas containers that are not manufactured with a permanent gas use outlet connection must have gas-specific use outlet connections that cannot be removed nor replaced, except by the manufacturer.

FDA also requires that portable cryogenic medical gas containers as well as high pressure medical gas cylinders adhere to stipulated naming, labelling, and color requirements.

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