QUALITY POLICY
Quality is a key priority in every aspect of our business.
Our patients trust us to deliver high-quality standards and
we are committed to meet their expectations. At GEN we have a robust
quality management system with our highly coherent processes and procedures.
GEN QUALITY SYSTEM
GEN Quality System is built in accordance with the regulatory
requirements of national and international health authorities:
• T.R. Ministry of Health, Medicinal Products for Human Use Workshops, Good Manufacturing Practices Guide
• U.S. FDA 21 CFR 210 & 211
• EudraLex Volume 4 – Part 1 GMP Guide
• ICH Q10 Pharmaceutical Quality System Guide
• Pharmaceutical Inspection Co-operation Scheme (PIC/S)
• ISO 9001:2015 Quality Management System Standard
GEN has a robust and independent audit program covering the entire GEN Manufacturing Complex and its functions, as well as its suppliers. Audits carried out since Gen’s establishment:
GEN Quality Control Laboratories
We have different laboratories with high standards, including
Quality Control Laboratory, In-Process Control Laboratory, Microbiology Laboratory and Technology Transfer Laboratory,
which are established on an area of approximately
1.400 m²
Our products (release and stability) and support units (pure water, water for injection, pure steam, nitrogen, etc.)
produced together with raw materials and packaging materials are analyzed by our expert teams,
in our modern laboratories in accordance with in accordance with the latest technologies.
Precise measurements and reproducible results are obtained with
approximately 325 different devices, including 24 HPLC, 3 GC, and 1 ICP-MS.