The know-how to provide guidance
At GBA Group, we have the expertise to handle your product all the way to QP release in Europe
EU Batch Certification
Whether for commercial sale or clinical trial use, all pharmaceutical end products imported into or manufactured in the EU have to be certified and released by a Qualified Person (QP). This process is known as a QP release.
Shipment to customers is made only after our QP has approved and released each batch manufactured and checked in accordance with the legal requirements of the respective country.
The professional experience of our QP's ensures that we handle specific issues across the pharmaceutical spectrum - from small molecules to biopharmaceuticals and Advanced Therapeutic Medicinal Products (ATMPs) - quickly and competently.
Our Range of QP Services include:
- QP Back-Up Services
- Advice Relating to Regulatory Requirements
- Assistance with Batch Expiry Extensions
- Issue of QP Declarations and Manufacturing Site Audits
- QP Release Certification and Batch Release
- QP Batch Release and Consultancy Services for ATMPs
- Consultancy Services regarding GMP, GCP, GDP and GLP