Batch release testing and EU re-tests

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.

QP-certified batch release analysis

The analytical laboratory for medicinal products that Diapharm works with, 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.

Services of our partner laboratory

  • API release testing services
  • Batch release testing services
  • GMP-certified laboratory with manufacturing authorisation for product release in accordance with Directive 2001/83/EC
  • Licence acc. to section 3 of the German Narcotic Drugs Act
  • EU re-test / import testing / import authorisation for EU product release
  • QP certification, in reference to Annex 16 of EU GMP guidelines
  • Short turnaround times thanks to standardised procedures plus clear responsibilities and defined interfaces

The service laboratory 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.


 

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