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FDA inspection success

By May 11, 2023January 24th, 2024No Comments

In late April Chemika was the subject of an FDA audit of our operation. We have been registered as a facility with the FDA since November 2021, and this is the first time the FDA have travelled to audit us. Over the course of 3 days the auditor identified just a single observation relating to an instrument with legacy software. The instrument was scheduled for upgrade and due for completion by June 2023.

The scope of the audit was centred on products which are exported to the US. Given how recently we had registered as an FDA facility, and that we had not previously been inspected, this did not represent a large volume of testing. The testing did however cover almost all instrumental techniques in use at Chemika and extended to systems essential to the maintenance of quality and compliance, such as training, calibration, and data integrity.

Chemika commenced working towards compliance with FDA’s requirements in 2018. Numerous instruments were replaced to allow for control with modern DI compliant software, which itself required upgraded server equipment. Catherine Micallef led the quality team with John Rose looking after computer systems and Debbie Simpson in document control. Our team displayed admirable productivity achieving extensive system upgrades and generation of hundreds of pages of documentation.

Many of the changes required by the FDA were very similar to those required by the TGA, and part of our motivation in seeking compliance to both was that the two systems had converged over recent years. Nonetheless there are subtle differences between the PIC/S Code and 21 CFR Part 211 and all procedures needed to comply with both requirements.

The conduct of the audit reflected the professionalism and competence we expected from the FDA and proceeded in a very positive mindset focussing on our mutual goal of protecting the safety and health of US consumers.