Description

CGA M-3 – Standard for the Manufacturer of Bulk Medical Gases

This publication is a standard for compliance with the applicable regulations of the U.S. Food and Drug Administration (FDA) for the manufacture of bulk medical gases classified as drugs as described in Title 21 of the U.S. Code of Federal Regulations (21 CFR). It outlines the requirements for manufacturing bulk medical gases classified as drugs; however, it may not contain all information necessary to comply with FDA regulations. It is the responsibility of each gas manufacturer to ensure that their standard operating procedures (SOP) comply with all applicable federal, state, and local regulations.

This publication applies to the bulk manufacturing of medical gases as follows:
bulk air separation (oxygen, USP and nitrogen, NF) manufacturing and distribution facilities;
bulk carbon dioxide, USP manufacturing and distribution facilities;
bulk helium, USP manufacturing and distribution facilities; and
bulk nitrous oxide, USP manufacturing and distribution facilities.