PharmAust (ASX:PAA), a clinical-stage oncology company, has announced that its wholly-owned subsidiary Epichem has gained accreditation from NATA (The National Association of Testing Authorities) to ISO17034:2016, an internationally recognised standard of competence and capability for the production of Reference Materials.
ISO17034 sets a benchmark for reference material producers. Epichem is one of the first companies in Australia to achieve this standard of quality assurance for reference material production to support pharmaceutical drug manufacturing.
A Reference Material is used to check the quality of products to validate analytical measurement methods, or for the calibration of instruments and is a critical need for drug manufacturers. ISO17034 provides the highest level of quality assurance for the production and supply of these materials.
Epichem already holds ISO 9001:2015, the most widely used quality standard for management systems applicable to manufacturing and service organisations.
According to Epichem CEO Dr Martine Keenan, “We are delighted that Epichem has gained accreditation to ISO17034:2016. This will strengthen alliances with our existing customers, expand our client base and distinguish our products from competitors by placing us in a more exclusive tier of reference standard manufacturers. Epichem is looking forward to capitalising on these opportunities.”
PharmAust’s Executive Chairman Dr Roger Aston said, “This is an outstanding achievement by Epichem signifying the high standards to which the company operates.”