Dubininskaya str. 57, bld.1, 115054, Moscow, Russia
info@regapharm.com

+7(499)517-95-23

Main  >  News  >  Russian GMP Inspectorate. Brief results of Pharma-2020

Russian GMP Inspectorate. Brief results of Pharma-2020

On November 10, during the plenary session "Results of the implementation of the state program" Development of the pharmaceutical and medical industry ": together with a common goal", held as part of the 22nd International Exhibition Pharmtech & ingredients in Crocus Expo, Vladislav Shestakov, director of FBU "GILS and NP" of the Russian GMP Inspectorate and the results of its work for 4 years from the moment of its creation.

The main result of the work in 2020 was the transition to alternative methods of inspection in connection with the difficult epidemiological situation that has developed since February 2020 around the world. In order to avoid the risk of a shortage of medicines on the Russian market, in agreement with the Ministry of Industry and Trade of the Russian Federation and in connection with the amendments to the Decree of the Government of the Russian Federation No. 1314, the Russian inspectorate is authorized to conduct inspections of foreign manufacturers of medicines through remote assessment using modern technologies , including video communication in real time. More than 150 such online inspections have already been carried out in 2020.

Vladislav Shestakov noted a significant achievement in the development of the pharmaceutical inspectorate and the implementation of the Pharma-2020 state program on the work carried out on a preliminary application for Russia's accession to the Pharmaceutical Inspectorates Cooperation Scheme (PIC / S). The director of FBU SILS and NP thanked the colleagues involved in the preparation of the application. Currently, active work is underway to form a package of documents for the Checklist, the PIC / S Questionnaire and an application for full membership in PIC / S, the submission of which is scheduled for the 4th quarter of 2020.

THIS IS A DIFFICULT AND MULTI-STEP WORK, IN WHICH REPRESENTATIVES OF THE MINISTRY OF INDUSTRIAL TRADE OF RUSSIA, ROSZDRAVNADZOR, FBU "GILS & NP", FGBU "NTsESMP" are involved, - SHESTAKOV noted. - OUR PRELIMINARY APPLICATION WAS CONSIDERED AND LAST AUTUMN WE RECEIVED A POSITIVE EVALUATION OF OUR DOCUMENTS. THIS IS ANOTHER STEP TO RECOGNIZE THE COMPETENCIES OF OUR INSPECTORATE AT THE WORLD LEVEL.

Separately, the topic of creating a subsidiary company "National Center for Certified Samples" was touched upon, the main focus of which was the development, production and supply of state reference materials. For 9 months of work, the NTSSO has been certified and received sets of documents for three state standard samples: Ibuprofen, Fluconazole and Azithromycin. At present, normative documents are being developed for 17 new titles of GSO.

Of course, the implementation of the Pharma 2020 strategy has led to the development of not only the pharmaceutical industry, but also the pharmaceutical inspectorate,” summed up his speech Vladislav Shestakov. - The created system has proved to be effective and meets international standards. And I am sure my colleagues from the industry will support me, the Russian inspectorate and quality have long become synonymous. "

 

Make request

Your name

Your phone

Your email (required)

Choose the topic of your message

Your message