EU QP Services

EU QP Services

The location in Lörrach / Germany has got the approval to perform EU-Releases for

  • Medicinal Products
  • Investigational Medicinal Products (IMPs)

There are several Qualified Persons registered at the local authorities working for us including one QP for vaccines and sera.

 Permission issued by the local authorities comprises authorization to perform

  • EU Importation
  • Batch certifications
  • EU Release for human medicinal and investigational products for
    → sterile / non-sterile products
    → biological / immunological products (vaccines + sera)

Our QP-Services in detail:

  • Qualification of the supply chain, audit (if necessary)
  • Definition of testing scope and release specification for the EU
  • Review of the manufacturing and testing records, check for compliance with EU-GMP Guidelines and with Product Specification File
  • Import into EU (Germany)
  • Receipt of the medication, incoming inspection,
    storage under quarantine
  • Sampling and batch re-analysis (if necessary)
  • Release decision
  • Certification of Analysis, Certification of Compliance with EU-GMP Guidelines and PSF
  • Archiving of retain samples and documentation  in the EU