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 Diapharm Analytics testing laboratory has been licensed for the manufacturing authorisation and release of medicinal products, in accordance with EMA Directive 2001/83/EC. If requested, Diapharm’s own qualified persons (QPs) can certify the batch release testing conducted at our analytics laboratory.
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 we operate 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.