Conducting batch release analysis on behalf of a client is synonymous with partnership, communication, trust and control – but also with the many opportunities that become available for the design of the project.
The analytical laboratory for medicinal products Diapharm Analytics GmbH, a Tentamus company, has a manufacturing authorisation for testing an 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.
As a service laboratory, Diapharm Analytics operates as a partner, providing an extension to our clients’ workbench: we create the space and time to allow them to concentrate on their core business. For pharmaceutical companies and contract manufacturers.