The analytical laboratory of Quercus labo has an authorisation for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC. If requested, our own qualified persons (QPs) can certify the batch release testing.

In accordance with Annex 16 of the EU GMP Guidelines, the client’s QP can refer to this laboratory certificate – reducing the workload that is involved in the batch release of a finished medicinal product.

Also companies from non-EU states that want to import medicinal products can rely on Quercus for EU product release. We take care of EU import release responsibilities for companies outside of the European Union. Upon request, we can monitor (contract) manufacturing and ensure that quality management according to Good Manufacturing Practice (GMP) requirements are met.

This QP certification is performed fully in line with reference to Annex 16 of EU GMP guidelines.