New Rules of Conformity Assessment of Testing Laboratories with Good Laboratory Practice Principles

October 03, 2019

On October 3, 2019, the Decree of the Russian Government No. 1227 of September 20, 2019, entered into force approving new rules of recognition and assessment of conformity of testing laboratories with the Good Laboratory Practice principles and the relevant GLP principles of the Organization for Economic Cooperation and Development (OECD).

The document introduced the following changes in the procedure of recognition and assessment of conformity of testing laboratories with the Good Laboratory Practice principles of OECD:

  • ranking of inconsistencies between a testing laboratory (center) and the GLP principles that can be identified during inspections (introduction of concepts of significant and minor inconsistencies); and
  • creation of a Good Laboratory Practice Commission at RusAccreditation that will be responsible for the review of results of the conformity assessment of testing laboratories (centers) with the GLP principles.

The Decree of the Russian Government No. 1172 of December 17, 2013, “On Recognition and Assessment of Conformity of Testing Laboratories (Centers) to the Principles of Good Laboratory Practice Complying with the Good Laboratory Practice principles of OECD” shall repeal.

Arranging and conducting preliminary and full inspections according to the new Rules are assigned to the National Institute for Accreditation of RusAccreditation.