Information on the organization of a "hot line" of reference laboratories

Testing center of
St. Petersburg branch		 Testing center of
Rostov-on-Don branch		 Testing center of
Krasnoyarsk branch
Davydova Tatyana - head of the organizational department 1. Chumakova Irina - deputy of branch director
2. Sysoenkova Tatyana - head of the organizational department		 Styukhin Alexander - head of the organizational department
+7(967)090-10-35 1. +7(863)280-69-14, +7(909)640-01-93
2. +7(863)280-69-11		 +7(391)274-33-26
8:00 - 17:00 (MSK) 8:00 - 17:00 (MSK) 9:00 - 17:00 (MSK+4)

Reference laboratories of FGBU "IMCEUAOSMP" ROSZDRAVNADZOR

As part of the implementation of the activities of the Federal project "Systemic measures for the development of international cooperation and export" of the National project "International cooperation and export" and the Decree of the President of the Russian Federation No. 204 "On the national goals and strategic objectives of the development of the Russian Federation for the period up to 2024" dated May 07, 2018, three laboratory complexes of the FGBU "IMCEUAOSMP" of Roszdravnadzor were approved as reference laboratories of Roszdravnadzor, in which it is planned to conduct the necessary tests of pharmaceutical products in accordance with the methods recognized abroad:

Krasnoyarsk branch

St. Petersburg branch

Branch of the city of Rostov-on-Don

In accordance with the requirements established in the Federal project "Systemic measures for the development of international cooperation and export", by 2024, reference laboratories should carry out:

⩾40%

"tests (researches) in Russian testing laboratories in accordance with the methods recognized abroad, under the list of priority countries and types of products - not less than 40%";

⩾8%

"researches in Russian GLP-laboratories research in accordance with methods recognized abroad, under the list of priority countries and types of products - at least 8%."

In order to comply with the task for the readiness to conduct 100% of the volume of testing of pharmaceutical products, set before the reference laboratories, an active modernization of the reference laboratories of the FGBU "IMCEUAOSMP" of Roszdravnadzor is being carried out.

The following activities were carried out:

1
The protocol of the project committee of the national project "International cooperation and export" No. 5 of 17.06.2019 approved the Plan of modernization of reference laboratories, which includes laboratories subordinate to Roszdravnadzor of FGBU IMCEUAOSMP (Rostov-on-Don branch of FGBU "IMCEUAOSMP", St. Petersburg branch of FGBU "IMCEUAOSMP", Krasnoyarsk branch of FGBU "IMCEUAOSMP").
2
By the Technical Commission of the Federal Service for Accreditation to Ensure Conformity Assessment for the Purposes of Exporting Russian Products 12.02.2020 consideration and approval of three projects "Individual plan for modernization and development of the reference laboratory until 2024" of reference laboratories of the FGBU "IMCEUAOSMP" of Roszdravnadzor were carried out.
3
In accordance with the approved list of laboratory equipment required to upgrade reference laboratories, auctions were held and equipment was delivered to reference laboratories in 2020 for a total amount of 85 million rubles. The main directions of the supplied laboratory equipment:

Type of laboratory equipment

Example

Laboratory GLP Equipment (Veterinary Analyzers)

Laboratory Animal Cages (GLP)

Equipment for the study of the behavior of experimental animals (GLP)

Outdoor mobile laminar flow stations for laboratory animals (GLP)

Upgrading laboratories with modern general laboratory equipment to meet the requirements of GOST R ISO 17025

4

The rights to use the combined mark (ILAC and NSA) were obtained by all reference laboratories of the FGBU "IMCEUAOSMP" of Roszdravnadzor.