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PIC/S appoints an Audit Team to consider application from Russia

On 20—21 April a Committee meeting of PIC/S (Pharmaceutical Inspection Co-operation Scheme) took place, in which an Audit Team has been appointed for conducting an audit and processing Russia’s membership to the organization.

On 18 December 2021 the Russian Federation submitted an application for PIC/S (Pharmaceutical Inspection Co-operation Scheme PIC/S accession). The work on the application entailed a joint nature and was intense, several authorities of the Russian Federation and their subordinate organizations combined their efforts: Ministry of Industry and Trade of the Russian Federation, FSI SID&GP, Federal Service for Surveillance in Healthcare (Roszdravnadzor) and the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation.

On 21 April 2021 the second day of the 100th Committee meeting of PIC/S officials was held, in which the representatives of PIC/S member states participated. Within the framework of the meeting a decision was made to appoint an Audit Team comprising of the Team leader and 4 co-auditors to conduct assessment; it is them who will embark hereafter on considering and studying the membership application to PIC/S, and give their conclusion on the opportunity of the Russian Federation to become a fully-fledged member of the professional organization. In the case of a positive conclusion of the audit team, our country will confirm the high level of the regulatory system development at the international level.

“Accession of the Russian Federation to PIC/S will give the Russian GMP Inspectorate recognition at the international level, allow it to participate in the work on advanced inspection documents, take part in discussions and develop recommendations on inspection of pharmaceutical manufacturers for compliance with Good practices,” explains Vladislav Shestakov, Deputy Head of the Russian GMP Inspectorate, Director of the FSI “SID&GP”- “Joining PIC/S is a recognition of high regulatory quality standards in Russia at the level of international standards.”

Let us remind, that the Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international organization, which unites 54 foreign GMP-investigators (regulatory bodies). The goal of the organization is to develop, implement and maintain harmonized GMP standards and quality systems of inspections in the field of medicines, as well as to strengthen trust and interaction between inspectors of different countries.