QP services
Batch release

Batch release und QP services

The HWI group offers comprehensive services in the field of EU batch release and Qualified Person (QP) services.

Releasing drug batches

We take responsibility for releasing your drug batches in accordance with the requirements of the EU GMP guidelines and the German Medicinal Products Act (AMG). Our Qualified Persons ensure that each batch has been manufactured and tested in accordance with legal requirements.

Our services at a glance

Batch release in accordance with EU GMP Annex 16 by our QPs
Batch certification for human and veterinary medicinal products and investigational medicinal products (CTM)
Manufacturing license in accordance with Section 13 AMG for the batch release of clinical trial batches and market batches manufactured by HWI on behalf of customers
External QP services provided directly at your company
Import authorisation in accordance with Section 72 AMG for support with import and EU release in accordance with Annex 21

This is what sets us apart:

Many years of experience in development, manufacturing, analysis, and regulatory approval of medicinal products
High flexibility thanks to internal and external QP services
Proven processes and established quality assurance

Trust in our expertise for safe medicinal products and reliable release processes.

Visit our blog on batch release of medicinal products and for further insights into regulatory requirements and the role of the QP.

Contact us. We’re happy to help!

Anne Göckler
Head of Quality Services

Phone: +49 7272 7767-2548
Email: a.goeckler@hwi-group.de

Sabine Flory
Sales Manager

Phone: +49 7272 7767-2380
Email: sales@hwi-group.de

Contact form

Fragen und Antworten

What is a Qualified Person (QP)?

A QP is a knowledgeable person who, in accordance with Section 14 of the German Medicinal Products Act (AMG), is responsible for ensuring that batches of medicinal products have been manufactured and tested in accordance with the regulations. They confirm compliance with all relevant regulatory requirements and GMP regulations and certify the release.

What role does AI play in batch release?

Artificial intelligence can support processes such as research, document review, data analysis, and risk assessment. However, it does not replace the legally defined responsibility of the QP but serves as a complementary tool to increase efficiency and prevent errors.

Can AI take over the work of a QP?

No. Responsibility for batch release remains exclusively with the Qualified Person according to the German Medicinal Products Act (AMG). AI can only perform preparatory tasks, such as analyzing production data or checking for regulatory compliance.

How does HWI support the import of medicinal products?

With our import license in accordance with Section 72 AMG, we take care of the EU release of your imported products and ensure that all requirements in accordance with Annex 21 are met — including document review and quality assessment.