QUALITY POLICY

Is to produce and introduce our products and services according to good manufacturing practices (cGMP) with the guiding principle of customer orientation and to provide quality, continuity and continuous improvement at services.
We are committing;

        - Follow ethic rules,
        - Provide all kinds of source requirements for production convenient to cGMP and to make high-standard production while following technology,
        - Apply legal requirements by following them which are valid for quality and products,
        - Assist personal improvements of our employees.

The production process at the Eczacıbaşı Monrol Gebze Plant was audited by the Danish Medicines Agency in May 2010 and the most important step for marketing authorization for European countries was the SPECT products (MON.TEK Mo99 / Tc99m Generator, MON.Iodine). -131 Oral Capsule has received GMP certificate for MON. This EU-GMP Certificate proves that the products are produced in accordance with the “Good Manufacturing Practices de at the Gebze Plant.

Certificates

The production process at the Eczacıbaşı Monrol Gebze Plant was audited by the Danish Pharmaceutical Agency in May 2010, and as a result of this inspection, which is the most important step for marketing permission to European countries, SPECT products (MON.TEK Mo99 / Tc99m Generator, MON.İod) -131 Oral Capsule has received GMP certificate. The continuation of the GMP certificate to be audited by the Hungarian Pharmaceutical Agency in July 2013 and the Romanian Pharmaceutical Agency in July 2017. This EU-GMP Certificate proves that the products at the Gebze Plant are manufactured in accordance with the “Good Manufacturing Practices”

Eczacıbaşı Monrol exports products to EU countries.

Since February 2002, Eczacıbaşı Monrol has ensured the continuity of its product and service quality with its ISO 9001: 2015 Quality Management Systems Certificate.

Since January 2002, ISO 14001: 2004 Environmental Management Systems Certificate ensures that environmental performance is monitored and improved continuously.

Furthermore, the production process at Eczacıbaşı Monrol Gebze Plant was inspected by Taiwan TFDA in March 2015 and obtained GMP certificate for MON.TEK Mo99 / Tc99m Generator, MON.Iodine-131 Oral Capsule products. Taiwan GMP Certificate proves that the products are produced in accordance with “Good Manufacturing Practices de at Gebze Plant.

Eczacıbaşı Monrol Production Facilities, regularly TİTCK (Turkey Pharmaceuticals and Medical Devices Agency) by cGMP regularly, it is controlled under cGDPR guidelines and Good Manufacturing Practices and Good Distribution Practices continuity is documented.