Publication Details

[PS-22] CGA Position Statement on Conforming with USP/NF Monographs for Medical Gases



Abstract:

USP is in the process of modifying the monographs for medical gases. This position statement defines the basic industry practices that will enable a medical gas manufacturer to be in compliance with FDA regulations during modifications to the USP/NF monographs.

This position statement sets forth acceptable industry test practices for products manufactured at ASU and cylinder filling operations. It also establishes the use of industry produced reference standards that are NIST traceable as an acceptable practice.


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