FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Experience of Independent Examination in Pharmaceutical Manufacturing

July 1st, the III annual GLP-Planet Conference on Good Laboratory Practice was held in Saint-Petersburg with the support of the FSI “State Institute of Drugs and Good Practices”, Ministry of Trade and Industry of Russia.

It is the third year that the conference took place. Its success proves the high relevance of the subject for the pharmaceutical community, as well as the need for such a discussion platform to talk over critical issues and make consolidated decisions for the development of GLP in the Eurasian Economic Union. The industry conference helps to develop a uniform efficient mechanism for GLP regulation within the EAEU and serves a platform for strengthening and expanding international cooperation in this area with foreign regulators and experts.

The development of good practices within the Union is extremely important for the harmonious functioning of the common pharmaceutical market within the Eurasian Economic Union, and the development of good laboratory practice in Russia and the EAEU has been discussed over the past few years at industry conferences, thematic round tables.

The FSI “SID & GP” of the Russian Ministry of Industry and Trade has been actively supporting the conference since its first year and the Institute’s staff have been actively involved in elaborating the business programme of the conference. Vladislav Shestakov, Director of the FSI “SID & GP”, inaugurated the conference with his welcoming remarks, while experts of the FSI “SID & GP” made presentations on the most topical issues of good practice development within the Union in a separate thematic session. During this session, the issues of regulatory control of the industry at the national and supranational levels were covered, the principles of continuity and consistency of the GxP system in the EAEU were considered, and reports on the experience of the Russian GMP inspectorate in pharmaceutical inspections were presented. Colleagues from the EAEU member states, in their turn, shared their experience in the implementation of the good practices system in the member states of the Union.

For the pharmaceutical industry, the issue of human resources and qualification of specialists remains particularly relevant, which was embraced by a number of presentations at the conference. For the second year, FSI “SID & GP” has been running an additional professional retraining programme for inspectors and auditors to assess the compliance of testing centres with the good laboratory practice rules. The programme was prepared together with the Peoples’ Friendship University of Russia, the Eurasian Academy of Good Practice, and leading GxP experts. This programme is essential to improve the skills of professionals across the industry, from quality assurance staff in testing centres to preclinical study auditors and regulatory bodies. The importance and peculiarities of the educational programmes were also highlighted by the specialists of the FSI “SID & GP” during the conference.

Workshops on the fundamentals of operating the equipment in the animal facility and pre- and post-operative care for laboratory animals and a seminar on assessment of the severity level of animal experimental procedures were held, too.

We would like to thank all the participants for being actively involved and the sponsors for extending support to the conference!

See you next year!