Roszdravnadzor’s Head Mikhail Murashko took part in the “Made in Russia – Recognized Abroad” Forum and spoke about the new technical potential of the Service for the State Control of Quality of Medicines.
Roszdravnadzor’s Head took part in the “Made in Russia – Recognized Abroad” Forum and told the forum participants about capabilities of Roszdravnadzor’s testing laboratories and the potential of their capacities for the launch of Russian products on foreign markets.
Today, Roszdravnadzor has 12 modern laboratory complexes functioning in all federal districts. These laboratory complexes are designed to test the drug quality by pharmacopoeial methods of any level of complexity.
Roszdravnadzor’s laboratory complexes in Rostov-on-Don, Krasnoyarsk, Khabarovsk and Yekaterinburg are ANAB accredited. Accreditation of laboratories in Kazan and Kursk is planned for March 2017.
ANAB is an American non-profit organization that offers accreditation services for testing, analytical and calibration laboratories, agencies certifying products, processes, services, management systems and personnel, and inspection authorities. ANAB is a member of ILAC, the international laboratory accreditation cooperation (incorporating 80 accreditation agencies from 64 countries of the world).
So, when applying to Roszdravnadzor’s testing laboratories that have been accredited by ANAB for compliance with the international ISO/IEC 17025:2005 standard, manufacturers of pharmaceuticals and other chemicals may get an internationally recognized quality certificate for launching their products on international markets.
Moreover, in October 2016 Roszdravnadzor’s All-Russian Research & Test Institute of Medical Equipment became a partner of the IMQ (Italy’s certification body) representative office across Russia and CIS.
“The international accreditations of Roszdravnadzor’s laboratories prove their compliance with the international requirements and a high level of their outfit, which should be used to promote Russian innovative medical products on the world market”, concluded Mikhail Murashko.
After the working session, the head of the Federal Service for Surveillance in Healthcare presented First Deputy Chairman of the Government of the Russian Federation Igor Shuvalov with Mini-Ram532, a hardware-software complex that has been developed by Roszdravnadzor in cooperation with a Russian manufacturer and has no equals anywhere in the world by its dimensions, ergonomic parameters and software (thanks to the Raman spectroscopy, the device checks the drug quality by using a non-destructive technique – without opening ampoules).
Igor Shuvalov spoke highly of the potential of the Mini-Raim532 hardware system and suggested that it should be implemented on a large scale, not only for the state control of drug quality and not solely on the Russian market. In particular, the device can be used to control drug quality in medical institutions, pharmacies, and pharmacy depots both in Russia and abroad.
In his turn, Roszdravnadzor’s Head pointed out that all portable laboratories of the Service have Mini-Ram532 devices and are actively using them in their work. Foreign colleagues are also interested in the device. The Raman spectrometer was presented to the US Pharmacopeial Convention (USP) and the Indonesian regulatory authority and their specialists gave a high appraisal of the capabilities of the device and asked for the English application manual for further study.
Information from Roszdravnadzor: the Raman spectrometer can be used to control drug quality as early as at the stage of manufacturing, at points of sale of pharmaceuticals and in various medical institutions. The method can be also used to control solutions prepared by the medical staff right before use.
The Mini-Ram532 analysis technique fully meets the quick-test criteria and does not require the involvement of skilled staff.