QP Services
Your Partner for EU QP Services
Products having a marketing authorization or clinical trial materials have to be certified and released by a Qualified Person (QP). Delivery to customers / patients takes place only after our QP has released every lot produced and controlled in accordance with the relevant country’s legal requirements. Our service includes:
- Advice relating to regulatory requirements
- Consultancy services regarding GMP and GDP
- Qualification of the supply chain, audit if necessary
- Review of the manufacturing and testing records and check of compliance with EU GMP, IMPD and with the Product Specification File
- Release decision
- Certificate of Analysis, Certificate of Compliance with EU GMP, IMPD and with the Product Specification File
- Archiving of retain samples and documentation in the EU
In addition, in case of EU-Import:
- Definition of testing scope and release specifications for the EU
- Incoming inspection of the received drug products, storage under quarantine until release decision
- Sampling and batch re-analysis, if required