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EU Batch Release

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EU Batch Certification & EU Release by QP (Qualified Person)

Every batch of investigational or market authorized medicinal product used in the European Union has to be certified and released by a QP. Delivery to customers takes only place after our QP has certified that every production batch has been produced and controlled in accordance with the relevant EU legal requirements and any other EU regulations relevant to the production, control and release of medicinal products.

This certification process including the EU Batch Release and it applies to medicinal products imported from outside the European Union as well as batches that undergo labeling and packaging procedures in house, and it assures that the quality of all our shipments complies with the highest possible EU quality requirements.

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Detailed listing of our Qualified Person (QP) services

  • Qualification of the supply chain and audit (if required)
  • Definition of testing scope and release specification for the European Union
  • Review of manufacturing and testing records, checking for compliance with EU-GMP Guidelines and with the Product Specification File
  • Import into EU (via Hungary)
  • Receipt of the medication, incoming inspection, storage under quarantine
  • Sampling and batch reanalysis (if required)
  • Release decision
  • CoA (Certification of Analysis), CoC (Certification of Compliance) with EU-GMP Guidelines
  • Archiving of retained samples and documentation

 

Get in touch to discuss your needs!

Vass Gergely
+36 30 914 9440
gergely.vass@eupharmahub.com