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Acute Angles of Inspections for Compliance

At a workshop recently held at the Chamber of Commerce and Industry «Key Stages of Preparation for Inspection of International Companies. Conclusions and Acute Issues of First Inspections” intermediate results of inspections of international companies for compliance with Russian GMP standards were summarized.

Inspection of international sites is one of the most acute issues for international pharmaceutical manufacturers. Workshop sponsors – Federal Budgetary Institution “State Institute of  Medicinal Drugs and Good Practices” and Social and Pedagogical Faculty (SPFO) had an objective to render those companies practical support in preparation for inspection. The companies should know that inspections are inevitable, remarks executive director of SPFO  Lilia Titova. It is a serious procedure that requires thorough preparation».

Vladislav Shestakov, Director of Federal Budgetary Institution State Institute of Medicinal Drugs and Good Practices says that by July 21 the Ministry of Industry and Trade has received 291 applications (including six repeated applications).  157 applications were given to FBI SIMDGP. Currently inspectors have been present at 40 manufacturing sites. Three international pharmaceutical companies  have received certificate for compliance with Russian GMP rules, and 16 companies received refusals. Seven companies postponed inspection. Three companies recalled applications.

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