EUQP batch release

EUQP batch release

Acting as an external Qualified Person (QP) we assume responsibility for batch release of medicinal products and IMPs.

We also take care of EU import release responsibilities for companies outside of the European Economic Area. We monitor (contract) manufacturing and ensure that quality management according to Good Manufacturing Practice (GMP) requirements are met.

Batch release services

  • Batch release for medicinal products in compliance with Good Manufacturing Practice (GMP) requirements and for medical devices
  • Release of medicinal products for clinical trials (investigational medicinal products)
  • Batch release for medicinal products with special requirements such as … vaccines, narcotic drugs and genetically engineered pharmaceuticals
  • QP-certified batch release analysis
  • Import release for medicinal products from companies outside of the EU / EEA

Certifications

Depo Pack - Autorizzazione_aAMM-35_2021-1

AUTORIZZAZIONE aAMM-35_2021
Depo Pack - GMP_IT-26-H-2021-1

CERTIFICATO GMP IT-26-H-2021
Depo Pack -

AUTORIZZAZIONE UCS 275/2021