Qualified persoN

The following (interim) Qualified Person services can be provided by Pharma Quality Support:

• Commercial batch release (QP certification) for finished products, according to Eudralex Volume 4 Annex 16  and Directive  2001/83/EC (human), 2001/82/EC (veterinary).

• Batch QP certification according to Eudralex Volume 4 Annex 16 and Annex 13 for investigational medicinal products (IMP) and clinical trials conducted according to Directive 2001/20/EC.

When releasing a batch, a Qualified Person (QP) will certify that the requirements of Good Manufacturing Practice (GMP) are met.  The QP must ensure that the batch is safe and effective for its intended use and that it complies with all relevant regulatory requirements and quality standards throughout the supply chain.