GLP system must be viewed by the pharma in a common set with all good practices

GLP system must be viewed by the pharma in a common set with all good practices

On 5 July in Saint Petersburg the second annual conference on good laboratory practice “GLP-Planet” has commenced its work. FSI “State Institute of Drugs and Good Practices” of the Russian Ministry of Industry and Trade of the Russia Federation has been supporting the conference for the second year. In the course of the plenary session Director of FSI “ SID & GP” Vladislav Shestakov spoke about interim results of the Institute’s work in the development of GLP system in Russia and EAEU.

No longer does the entire pharmaceutical industry dispute the fact that the establishment of a good laboratory practice system on the territory of the Eurasian Economic Union is the most important phase in forming strong pharmaceutical industry, products of which may enter into competition with the world’s leading manufacturers.

The issues pertinent to development of the system of good laboratory practices in Russia and the EAEU have been neing discussed over the past several years at the sectoral conferences and thematic round tables. Moreover, since 2025 all drugs on the territory of the EAEU shall be registered as per uniform rules, according to which all drugs must be indicated with a mark stating the compliance of laboratories for clinical studies with GLP standard.

The success of the specialized conference on GLP-related issues, which was first held last year, has demonstrated an acute relevance of this issue for pharmaceutical community, and also the necessity for having such discussion platform in order to talk about pressing issues and take consolidated decisions with a view of developing GLP filed on the Union’s territory.

During the year 2020 FSI “SID&GP” has significantly expanded its competencies in the field of all Good Practices, including laboratory practices, – said Vladislav Shestakov, Director of FSI “SID&GP” in his speech. – During the year inspectors of FSI “SID&GP” improved their qualification in GLP at several specialized sites and received certificates of the established form. This year the Institute has successfully passed the external conformity assessment of the Inspection Body in order to expand the scope of accreditation of inspection for compliance with the EAEU GLP. Now we are waiting for the corresponding final document from the Federal Service for Accreditation, after which we will be able to start inspections for compliance with the EAEU GLP rules in full.

Also in his speech Vladislav Shestakov noted that one of the critical issues in the formation of the system of Good laboratory practices is the question of professional training of GLP specialists in Russia and the EAEU:

We consider the issue of creating the best conditions for the training of GLP professionals to be particularly relevant. As we announced at the last conference, we have fulfilled the task we announced in 2020. During the last year the program of additional professional retraining of inspectors and auditors on estimation of compliance of testing centers with GLP rules was developed and approved. The program was prepared together with the Peoples’ Friendship University of Russia, the Eurasian Academy of Good Practices, and leading experts in the field of Good pharmaceutical practices.

In conclusion Vladislav Shestakov indicated the readiness of FSI “SID&GP” on its part to actively support the creation of a unified effective mechanism of GLP regulation in the EAEU territory, development of GLP Inspectorate of the Union, as well as strengthening and expansion of international cooperation in this area with foreign regulators and experts.

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