The recognition and assessment of conformity of testing laboratories (centers) with the principles of GLP in 2017

March 30, 2018

In 2017 the Federal Service for Accreditation provided 9 public services and conducted 15 inspections within the framework of exercising the authority to recognize and assess the conformity of testing laboratories (centers) with the principles of Good Laboratory Practice (GLP).

6 out of 9 public services are provided within the program on administrative procedure for conformity assessing of GLP principles under the requirement of the Decree of the Russian Federation Government dated December 17, 2013 No. 1172 on inspection of testing laboratories for conformity assessing of GLP principles included into GLP register every two years. As a result of their provision, all the following testing laboratories (centers) have confirmed their status:

  • FBIS “F.F. Erisman Federal Research Center” of Rospotrebnadzor;
  • FPFIS “The Institute of Toxicology” of FMBA of Russia;
  • Krasnoyarsk affiliated branch laboratory facility SFFEI “Information Expertise Center for Expertise, Accounting and Analysis of Medical Applications Treatment” of  Roszdravnadzor;
  • FSUE “State Research Institute of Organic Chemistry and Technology  (GosNIIOKhT)” of the Ministry of Industry and Trade of Russia;
  • FSFHI “Moscow Center of Hygiene and Epidemiology”;
  • Rostov-on-Don affiliated branch laboratory facility FSFEI “The Information Expertise Center for Expertise, Accounting and Analysis of Medical Applications Treatment” of Roszdravnadzor.

In January, 2018 St. Petersburg affiliated branch laboratory facility FSFEI “The Information Expertise Center for Expertise, Accounting and Analysis of Medical Applications Treatment” of Roszdravnadzor confirmed a status in accordance with GLP principles.

During the year the inspections also confirmed the status of the accordance with GLP principles of two testing laboratories: FPFIS “Institute of Physiologically Active Compounds” and FSFEI "Russian State Agrarian University – Moscow Timiryazev Agricultural Academy”.

On March 30th, 2018 the register contains information about 11 Russian testing laboratories that accord with GLP principles:

  • The Federal Publicly Funded Institution of Science “The M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry ”, RAS;
  • The Federal Publicly Funded Institution of Science “The Institute of Toxicology” of the Federal Medical-Biological Agency;
  • The Federal Budget Institution of Science “F.F. Erisman Federal Research Center” of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing;
  • The Federal State Unitary Enterprise “State Research Institute of Organic Chemistry and Technology” (FSUE “GosNIIOKhT”);
  • The Federal State-Funded Educational Institution “The Information Expertise Center for Expertise, Accounting and Analysis of Medical Applications Treatment“ of the Federal Service for Surveillance in Healthcare (Rostov-on-Don affiliated branch);
  • The Federal State-Funded Healthcare Institution “Moscow Center of Hygiene and Epidemiology”;
  • The Federal State-Funded Educational Institution “The Information Expertise Center  for Expertise, Accounting and Analysis of Medical Applications Treatment“  of the Federal Service for Surveillance in Healthcare (St. Petersburg affiliated branch);
  • The Federal State-Funded Educational Institution “The State Research Center “The National Institute of Immunology” of the Federal Medical-Biological Agency;
  • The Federal State-Funded Educational Institution “The Information Expertise Center for Expertise, Accounting and Analysis of Medical Applications Treatment“ of the Federal Service for Surveillance in Healthcare (Krasnoyarsk affiliated branch);
  • The Federal Publicly Funded Institution of Science “Institute of Physiologically Active Compounds, RAS”;
  • The Federal State-Funded Educational Institution of Higher Professional Education "The Russian State Agrarian University – Moscow Timiryazev Agricultural Academy".