CGA M-5 PDF

CGA M-5 – Guide for Home Respiratory Care Firms Filling or Distributing Liquid Oxygen USP, Second Edition

The information in this guide is an aid for complying with the applicable regulations of the U.S. Food and Drug Administration (FDA) and Health Canada for filling, packaging, testing, labeling, and holding liquid oxygen USP by home respiratory care (HRC) firms to ensure that product is manufactured and distributed in accordance with United States and Canadian current good manufacturing practices (CGMP) and meets all United States Pharmacopoeia (USP) specifications.

This publication describes the processes, procedures, and documentation typically recognized by the HRC industry as the minimum regulatory requirements needed for compliance.