Hence, BOC Healthcare complies with the strict requirements and standards for the manufacture and quality control of pharmaceutical gases stipulated by the appropriate regulatory bodies.
Documentation of pre-clinical and clinical aspects
In documenting the pre-clinical and clinical aspects of our medicinal gases, we have followed the pharmaceutical guidelines set by the International Conference of Harmonization (ICH). In the case of traditional medicinal gases such as oxygen, HELIOX21® or ENTONOX® our documentation refers to publicly available scientific literature, in accordance with guidelines set out by the Medicines and Healthcare products Regulatory Agency (MHRA).
Directives and Quality Management Systems (QMS) standards
The following directives and QMS standards are applicable for the manufacture, distribution and marketing of gases classified as a medicinal product:
2001/83/EC Directive. Amended by 2004/27/EC Directive
75/318-319 EEC Regulatory
2003/94/EC Directive. 91/356/EEC GMP (Good Manufacturing Practice)
94/25/EEC GDP (Good Distribution Practice)
2001/20/EC Directive and 2005/28/EC Directive (Good Clinical Practice)
EC/726/2004 Regulation (Community procedures and EMEA)
To learn more about the requirements and standards for the manufacture, distribution and marketing of pharmaceutical gases, please click the links to the relevant regulatory body websites and/or regional regulatory bodies in the right sidebar.