Unfortunately and all too common occurrence, an Australian company, acting as the Australian sponsor for a range of sterile medical devices manufactured in a country “north of Australia”, was hit with a notice from the Australian regulator, the TGA, that their products had been tested and were found to be non-sterile.
The TGA provided the sponsor opportunity to present validation evidence and attempt to understand the problem, however after the failure to supply any sensible validation evidence, the TGA requested that the product was to be recalled and a investigation into the problem to prevent a occurrence.
The company commissioned one of PharmOut’s vendor assurance consultants to perform review the validation data and carry out a third party audit of the supplier’s manufacturing facility, to determine their capabilities and how to best resolve the problem. At this stage the Australian sponsor was hopeful to still release several million dollars of stock held in Australian warehouses.
The audit at the supplier’s facility revealed that no product had been sterilized (with Ethylene Oxide) for several months, as they had been an argument between the owners of the facility, and therefore they were unlikely to pass a TGA inspection and did not have the necessary controls in place to ensure product quality.
PharmOut used its considerable network within China and identified an alternative manufacturer, with the existing appropriate TGA approvals and the capabilities to do the work to the required standards.
PharmOut was able to add a visit to the new supplier during an already planned trip to China. At the supplier’s facility, the PharmOut consultant confirmed that all the necessary validation documentation was in place for the sterilisation process, as well as for other processes that were deemed a risk to product quality and patient safety.
The old saying still rings true today, “you get what you inspect” and that’s why vendor assurance programs are so important!