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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

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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:

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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.