Batch release testing

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 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.

Diapharm Analytics' services

  • GMP-certified laboratory
  • Manufacturing authorisation for product release in accordance with Directive 2001/83/EC
  • EU retest / 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

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.

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  2. Service hotline: +49 251 609350

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