The company has a functioning quality system embracing all the aspects of GMP Rules and ISO 9001. Pharmaceutical quality system is implemented through a complex approach to quality assurance and control, by applying principles of continuous improvement by risk analysis, changes and assessment of declinations, tendencies and processes functioning.
All production sites of GEOPHARM have licenses to
manufacture drugs (pharmaceutical substances and medicinal products) and
comply with the requirements of GMP Rules approved by a decree No. 916
of the Ministry of Industry and Trade of the Russian Federation dated
June 14, 2013.
Production of finished dosage forms at the plant in Obolensk is certified according to GMP European Standard (GMP No. LT/04H/2018 dated October 16, 2018).
Quality Assurance Department (QA) and Quality Control Department (QC) provide for functioning of the pharmaceutical quality system and for the relevant control.
Basic provisions of the pharmaceutical quality system, regulation of compliance with GMP Rules and ISO 9001 are defined in the Quality Manual and Quality Policy.