BOC Healthcare complies with the strict requirements and standards for the manufacture and quality control of medical gases stipulated by the appropriate regulatory bodies.
Documentation of pre-clinical and clinical aspects
In documenting the pre-clinical and clinical aspects of our medical gases, we have followed the TGA guidelines. In the case of traditional medical gases such as oxygen, HELIOX28® or ENTONOX® our documentation refers to publicly available scientific literature, in accordance with guidelines set out by the Therapeutic Goods Administration (TGA).
Directives and Quality Management Systems (QMS) standards
The following legislation is applicable for the manufacture, distribution and marketing of gases classified as a medicinal product :
CPIC/s Code of Good Manufacturing Practice
Relevant Codes, Guides and Orders
Licenses to Manufacture, Package & Sell Medicines
European Pharmacopoeia Monographs
Relevant NZ, NZ/AUS and ISO Industry Standards
Dangerous Goods Legislation
Scheduled Medicine Licences
Schedule Medicine Legislation (SUSMP)