We acknowledge the importance of being inspected by authorities and audited by customers, and we are constantly inspection & audit-ready.
We have a proven system in place for physical audits, that also can accommodate virtual audits.
We also welcome third-party audit companies who can under an agreement with us, share their results on customer demand.
For our Quats, we are regularly inspected by the Danish Medicines Agency (DMA) for compliance with the EU GMP Vol 4, Part II (API) / ICH Q7 guideline for APIs. The DMA inspection report is shared with the US FDA, where we are registered as an API manufacturer.
We are also regularly audited by a Notified body (DNV) for the 3 ISO standards: ISO9001, ISO14001 and ISO45001.
In addition, we perform internal audits and are audited by Novo Nordisk.
Our employees are very routined in participating in audits, and we have a strong and transparent audit culture.
In total, an average of 30 customers are auditing us each year.
To the list of audits, we can add a document-based Sustainability audit performed by EcoVadis.
We obtained our first certification at the end of 2022 where we granted Platinum level.
We take pride in our inspection and audit results, reflecting our commitment to quality, reliability and sustainability.
Quality Audits and Inspections
Environment, Health & Safety (EHS) Audits and Inspections