The expertise to guide
At ABF we have the expertise to guide your product all the way to QP release.
EU Batch Certification
Whether for commercial sale or clinical trial use, a finished product must be certified and released by a Qualified Person (QP). This process is known as a QP release.
Delivery to customers takes place only after our QP has released every batch produced and controlled in accordance with the relevant country’s legal requirements.
The experience of our Qualified Person ensures that we swiftly and expertly handle specific issues across the pharmaceutical spectrum – from small molecules to biopharmaceuticals and Advanced Therapeutic Medicinal Products (ATMPs).
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