Batch Release & Qualified Person

Within Diapharm's manufacturing and import authorization, Qualified Persons (QPs) are responsible for batch certification of medicinal products.

The Qualified Person (QP) is the key figure for medicinal product quality, ensuring that every batch of a medicinal product is tested, certified, and released to the market in accordance with the highest EU standards.

Batch Release & Qualified Person

Within Diapharm's manufacturing and import authorization, Qualified Persons (QPs) are responsible for batch certification of medicinal products.

Batch Release for medicinal products

Diapharm’s Qualified Persons (QPs) assume responsibility for the final step of manufacturing: batch certification in accordance with GMP.

For companies outside the European Economic Area, Diapharm can handle EU import batch release.

These services include:

  • Batch release certification for medicinal products (GMP-compliant)
  • Certification of investigational medicinal products for clinical trials
  • Release analytics and QP certification
  • Import release for products manufactured outside the EU/EEA
  • Acting as the legally required Qualified Person on behalf of our clients

This allows companies to market products in the EU without holding their own manufacturing license or having to employ their own QP

 


 

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