What are QP services?
Any company involved in the manufacture and testing of a medicinal product is required to have a Qualified Person.
The Qualified Person is responsible for ensuring that manufacturing and/or testing is carried out in accordance with EU GMP guidelines and European regulations.
In other words, a medicinal product must be cleared by a Qualified Person before it may be delivered to the European market.
If the medicinal product is manufactured outside the European Union, EU import control is required, which can be performed by Quercus Labo (part of the QbD Group).
Why QbD Group?
QbD has years of QP experience and offers a wide range of experts who can act as QP or Back-up Qualified Person, from juniors to seniors.
We are also able to offer you EU import testing and batch certification thanks to the MIA license of Quercus Labo, part of the QbD Group.
After manufacturing and testing, the final step in the manufacturing process is batch certification. Batch certification can be performed if the manufacturing and testing are performed according to GMP guidelines.
Prior to certification, our QP personally ensures that certification is permitted under the terms of the MIA, that any additional obligations and requirements of national legislation are met, and that the certification is recorded in a registry.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right QP services.