Quality Assurance for GMP products
The production of GMP products are manufactured under a comprehensive quality system designed, implemented, controlled, and documented to ensure the quality of the product is as required in a risk assessed manner.
Company QA Overview
Eurogentec has maintained a Quality Management System that guarantees each employee always operates in respect to standard procedures and fulfills our global quality policy.
Quality System for BioPharmaceuticals
Manufacturing of GMP BioPharmaceuticals is ensured by our GMP trained personnel. Every batch is validated by a qualified person before release.
Our GMP Quality Management System is in compliance with relevant pharmacopoeia, FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.