Compliance

Manufacturing Qualifications and Standards

ORION is a GMP (Good Manufacturing Practice) compliant manufacturer. A comprehensive Qualification and Validation Program is being carried out in the new facility to prove control of the critical aspects of the production operations.

All procedures used by ORION are regularly audited by means of internal audits for ongoing compliance and systematic improvement.

These independent audits plus a comprehensive and rigorous internal testing schedule form part of the intensive program that ORION undertakes as part of its commitment to attain continued improvements in all facets of its business.

Regulatory Licences

The company holds a Therapeutic Goods Administration (TGA) licence to manufacture, package and store non-sterile & terminally sterilised medicinal products for human use, and an Australian Pesticides and Veterinary Medicines Authority (APVMA) manufacturing licence for Category 2 & 4 veterinary products. All manufacturing is compliant with the the Code of Good Manufacturing Practice for Therapeutic Goods.


All therapeutic goods manufactured and marketed by ORION comply with the Therapeutic Goods Administration (TGA) and the State Department of Health. Products are either registered or listed on the Australian Register of Therapeutic Goods (A.R.T.G.) administered by the TGA and comply with all labelling requirements.