05/03/2024
Isotope JSC successfully completes the first compliance audit to evaluate its adherence to GDP guidelines
Isotope JSC (part of Rosatom's Health Technologies Division) has successfully completed the first compliance audit to check the quality system for the distribution of radiopharmaceuticals and confirmed its compliance with the Guidelines of Good Distribution Practices (GDP 2013/C 343/01).
A compliance audit is carried out annually after the certificate is issued and confirms that the company's activities comply with the requirements of the GDP standard. Inspections allow to regularly improve the Quality Management System (QMS). The audit was carried out by experts from the certification body Inspect (Türkiye). Earlier, Isotope JSC confirmed the compliance of its management systems with the national standard GOST R ISO 9001-2015 and international standards ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018.
"The successful completion of the audits to evaluate the compliance of the management system with national and international standards describes the Rosatom State Atomic Energy Corporation as a reliable supplier of isotope products and services, which contributes to achieving the goals of the State Corporation to provide healthcare institutions with high-quality and safe medicinal products for nuclear medicine," noted Maxim Kushnarev, Director General of Isotope JSC.
The government and relevant departments are working on a planned improvement of the Russian healthcare capacities, ensuring full sovereignty of our country in this area. As a partner of the state in increasing the expectancy and quality of life of the country's population, Rosatom is increasing the production of a wide range of medical equipment and radiopharmaceuticals and creating a completely import-independent system for providing health care (diagnosis and treatment of socially significant diseases) to Russian citizens.
