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.
This publication describes the processes, procedures, and documentation typically recognized by the HRC industry as the minimum regulatory requirements needed for compliance.
More Standards PDF
CIE 205:2013
$46.00 $92.00
CSA 12.52-2014 (R2018) / ANSI NGV 4.2-2014 (R2019)
$172.00 $344.00
CLSI QMS15-A
$90.00 $180.00
CSA ANSI HPRD 1-2013 (R2018)
$172.00 $344.00