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Kalite Politikamız

QUALITY POLICY

Our quality policy is to manufacture and offer our products and services in a customer-oriented manner in accordance with good manufacturing practices (cGMP) and to ensure quality, continuity, and continuous improvement in our services.

We commit;

        - To follow ethical rules,
        - To provide all kinds of source requirements for manufacturing in accordance with cGMP and to manufacture at high standards while following technological developments,
        - To apply and follow legal requirements applicable to quality and products,
        - To apply and follow legal requirements applicable quality and products,
        - To assist the personal and technical development of our employees by creating an effective training system within the organization,

        - To create a common organizational culture around organizational mission, vision, and strategy.

By creating an effective training system within the organization.

        - To create a common organizational culture around organizational mission, vision, and strategy.

Certificates

The manufacturing process at the Eczacıbaşı Monrol Gebze Facility was audited by the Danish Pharmaceutical Agency in May 2010, and GMP certificate was obtained for SPECT products (MON.TEK 99Mo/99mTc Generator, MON.Iodine-131 Oral Capsule, MON-Iodine-131 Oral Solution) as a result of this audit, which is the most important step for marketing authorization in European countries. GMP certificate was maintained in the later periods through audits by the Hungarian Pharmaceutical Agency, Romanian Pharmaceutical Agency, Danish Pharmaceutical Agency, and Bulgarian Pharmaceutical Agency. This EU-GMP certificate proves that the products at the Gebze Facility are manufactured in accordance with“Good Manufacturing Practices.”

The manufacturing process at Eczacıbaşı Monrol Gebze Facility was audited by Taiwan TFDA in March 2015 and a GMP certificate was obtained for MON.TEK 99Mo/99mTc Generator, Mon.Iodine-131 Oral Capsule products. It has been proven with the Taiwan GMP certificate that the products are manufactured in accordance with "Good Manufacturing Practices."
Eczacıbaşı Monrol Production Facilities are regularly inspected by TITCK (Turkish Medicines and Medical Devices Agency) within the scope of cGMP, cGDP guidelines and the continuity of Good Manufacturing Practices and Good Distribution Practices is documented.

Eczacıbaşı Monrol exports products to EU countries.

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


In addition, Eczacıbaşı Monrol has assured the improvement and maintenance of its performance in controlling Occupational Health and Safety risks with the OHSAS 18001:2007 Occupational Health and Safety Management Systems Certificate obtained in February 2012.