Qualification of a product from a specific producer is a cooperation between Fagron Procurement and Fagron Quality.
The documentary package consists of e.g. GMP certificates, manufacturing licence, CoA, questionnaire product and producer, stability data, MSDS, methods of analysis and solvents and a TSE/BSE statement where applicable. Only when the product and producer are fully approved by Fagron Quality, Fagron Procurement can place its first order.
Internal and external audits
Besides qualification based on documentation Fagron Quality also conducts internal and external audits to ensure consistency of the high quality standard Fagron is delivering. The internal audits are performed to ensure compliance with local and global legislation and with Fagron’s internal procedures. The external audits are conducted among producers, agencies, third-party laboratories and distribution companies. This is to ensure that the companies with which Fagron is cooperating maintain the same quality standards as Fagron, and that they will therefore contribute to the high quality of Fagron products.
Fagron Compounding Supplies Australia
Fagron Compounding Supplies Australia Pty. Ltd. is fully compliant with Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 issued on the 13th of October, 2010 by the Therapeutic Goods Administration (TGA), a division of the Australian Department of Health.