Russian and Belarusian Pharmaceutical Inspectorates to conduct joint GLP training inspection

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Russian and Belarusian Pharmaceutical Inspectorates to conduct joint GLP training inspection

FBI “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation (FBI “GILS i NP”) together with representatives of regulatory authorities in healthcare of the Republic of Belarus have made a decision to conduct a training inspection to assess compliance with the good laboratory practice rules.

The main purpose of this inspection is to improve the skills of the industry inspectors of the EAEU member states. From the industry, the partner of the project will be the Preclinical Translational Research Centre FSBI Almazov National Medical Reseach Center of the Ministry of Health of Russia (PTRC complex). The PTRC complex carries out preclinical and translational trials of pharmacological properties, efficacy and safety of the drugs under development both for research and registration purposes.

The inspection will assess the conditions for the functioning of the quality assurance system of the industrial partner, the availability of qualified personnel, proper equiment in the premises, and the necessary materials for the implementation of preclinical research projects. Special attention during the inspection will be paid to the welfare of laboratory animals used in the experiments at the PTRC complex.

The member States of the Eurasian Economic Union apply the Rules of Good Laboratory Practice in accordance with the are set out in the Decision of the Council of the Eurasian Economic Commission No. 81 dated November 3, 2016 “On Approval of the Rules of Good Laboratory Practice of the Eurasian Economic Union in the Area of Circulation of Medicines”. Together with the description of routine requirements for compliance with the GLP rules on the part of preclinical trials sites, the regulatory legal act contains the Rules for Conducting Pharmaceutical Inspections in this area of GxP.

There is an unsatisfied need for pharmaceutical inspections to assess compliance with the GLP rules within the framework of preclinical drug trials in the member States of the Eurasian Economic Union. No such inspections are currently being carried out in any of the five EAEU member States.

A joint training inspection to assess compliance with the GLP rules will be held this year.