qualified person
Pharmaceutical companies within the European union are by law required to have a Qualified Person (QP) to take up responsibility for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU. A QP consultant ensures that production and testing are conducted in compliance with EU GMP guidelines and regulations. eyetec’s QP consultants combine experience in both operational and quality departments to translate these guidelines into processes, thus reconciling legal provisions with common industry practice.
eyetec has a team of expert QP consultants who have substantial QP experience in general and also possess knowledge on specific Aseptic processing, Advanced Therapy Medicinal Products (ATMP) and Investigational Medicinal products (IMP/IATMP) regulation.