Definition of the term “Additional materials” after conducting the inspection of foreign manufacturer

In preparation of the initiative on the acceptance of additional materials after the inspection of a foreign drug manufacturer, submitted an explanation of what is meant by used the term of “Additional materials.”

The term “Additional materials” means the following:

а) documents that for any reason were not provided to the inspector during the inspection that formed the basis for fixing the observations (for example: the results of the validation; the results of stability testing, the rationale for the method of sampling, etc.);

b) clarifying information requested by the inspector during the preparation of the inspection report (for example: clarifying the production scheme of the medicinal product; clarification of the stages of preliminary preparation of the starting materials (including APIs), mixing; clarification of schemes of manufacturing facilities, indicating their classification, clarifying the material and personnel flows and etc.); clarification of the sterilization scheme for the components of the solution in the manufacture of sterile medicinal products, using a sterilizing filtration; clarification of the scheme of capping the vials in the manufacture of a sterile medicine and etc.)»

For more details see the document on the official website of Minpromtorg of Russia: http://minpromtorg.gov.ru/