In preparation of the initiative on the acceptance of additional materials after the inspection of a foreign drug manufacturer, the Russian Federal State Institution “State Institute of Drugs and Good Practices” (SID & GP) submitted an explanation of what is meant by using 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.)
SID & GP is the expert organization engaged in the license control of pharmaceutical enterprises located in the Russian Federation. The organization is authorized to inspect the the foreign drug manufacturers’ compliance with the GMP Rules with the purpose of issuing the certificates of compliance with Good Manufacturing Practice.