Standard

CGA/GAS M-3

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Omfang

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. This publication is intended to address current good manufacturing practice (CGMP) requirements for: • Designated medical gases as defined in Section 575(1) of the Federal Food, Drug, and Cosmetic Act (Act) or combinations thereof; and • Other medical gases as defined in Section 575(2) of the Act that may be approved via a new drug application (NDA) or abbreviated new drug application (ANDA) for which the sponsor has shown through a science based risk management plan that this standard provides appropriate CGMPs [2]. Throughout this publication the terms medical gas or medical gases are used to refer to these categories of products. This publication does not apply to: • Firms that engage in the filling, repackaging, transfilling, mixing, and/or relabeling of compressed medical gas (CMG) classified as drugs. See CGA M-2, Standard for the Manufacture of Medical Gases Classified as Drugs [3]; • Refrigerated liquid oxygen USP that is filled at a patient’s residence or is filled, repackaged, transfilled, and/or relabeled by home respiratory care companies; and • Drugs that are defined as Investigational New Drug Applications. See the United States Pharmacopeia and National Formulary (USP—NF) for information on the USP and NF designations for medical gases [4].

Dokumentinformasjon

  • Standard fra CGA/GAS_AC
  • Publisert:
  • Versjon: 0
  • Varetype: IS
  • Tilleggsinformasjon
    • FIFTH EDITION