Press center Career Contacts Menu homeProductionQuality Quality The main goal of GEROPHARM is to be a reliable manufacturer of high-quality, effective and safe medicines that help people maintain and maintain health and a high quality of life. All production sites of the GEROPHARM group of companies are licensed to carry out activities for the production of medicines, the list of works of which provides for the production of pharmaceutical substances and medicines. The production sites of GEROPHARM comply with the requirements of the Good Manufacturing Practice Rules approved by the order of the Ministry of Industry and Trade of the Russian Federation dated June 14, 2013 No. 916. In March 2014, GEROPHARM successfully confirmed its compliance with the requirements of Good Manufacturing Practice by the State Service of Ukraine for Medicines and received a GMP 025/2014 / SAUMP / GMP certificate dated 07.04.2014. In September 2016, the company's quality system was highly appreciated by the RUE Center for Expertise and Testing in Healthcare, Republic of Belarus. The company has established and operates a documented pharmaceutical quality system, covering all aspects of GMP and ISO 9001. Ensuring the functioning of the pharmaceutical quality system and appropriate control are carried out by the quality assurance (QA) and quality control (QC) departments. 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. The enterprise carries out logging of procedures, processes, controls, implementation of quality system techniques, including the processes of production of products and their packaging. There is a procedure for evaluating production protocols and packaging protocols for batches of finished products, evaluating the results of quality control at all critical points of drug production, compiling a dossier for each batch of products. Production control measures eliminate the risk of cross-contamination. Finished products are sold only after assessing their compliance with the established requirements of industrial regulations and registration dossier with a corresponding permit. A permit for the release of medicinal products into civil circulation is granted by an authorized person. The GEROPHARM Group of Companies has an Institute of Authorized Persons who, when putting drugs into circulation, confirm the compliance of drugs with the requirements established during their state registration, and ensure that drugs are produced in accordance with the rules of production and quality control of drugs. Responsibility for product quality rests with the entire staff of the company. The efficiency of the pharmaceutical quality system is assessed by self-inspections, maintaining the appropriate level of efficiency is ensured by the system for the implementation of preventive and corrective measures. The pharmaceutical company's quality system includes, as a mandatory component, and assessment and qualification of suppliers / raw material manufacturers and packaging materials, changes in management, control deviations, compiling reports on product quality, risk management and so on. Established and functioning system of training of staff, covering all personnel involved in the production of medicines, their storage, quality control and assurance, ensuring the proper functioning of the technical systems of production sites, etc. There is a documented regulation regarding training programs, trainings, evaluation of the effectiveness of training. To confirm the consistency of the existing processes, compliance with the current specifications for both raw materials and finished products, to identify trends and determine the possibility of improving the products and the GEROPHARM process, product quality reviews are prepared annually. In order to prove the compliance of critical processes with the specified requirements, validation activities are carried out in accordance with the main validation plan. Due to the presence of its own park of test validation equipment, GEROPHARM can independently, on its own, carry out the qualification of clean rooms, engineering systems, qualify equipment: thermostats, autoclaves, dry ovens, climatic chambers, refrigeration units, map storage facilities, etc. The pharmaceutical quality system allows you to ensure, maintain and monitor compliance with targets at all stages of life. product cycle. Quality policy: Development, production and quality control of medicines (Quality, Safety, Efficiency) Achieve quality through the implementation of quality system rules, including Good Laboratory Practice GLP, Good Clinical Practice GCP, Good Manufacturing Practice GMP and Good Wholesale Practice GDP A clear distribution of functions and responsibilities of personnel. Full involvement of personnel in the creation of a quality system Availability of a sufficient number of trained personnel at all levels Compliance of the quality system with national and international legislation Willingness to take into account all comments made by competent authorities during inspections Introduction of advanced technologies and the latest control methods Technologies for a healthy future Our mission and values Pharmacovigilance The purpose of constant monitoring of the practice of using drugs is to guarantee their quality and safety. GEROPHARM Group "GEROPHARM" is a national manufacturer of biotechnological drugs that ensures drug safety in Russia Personal data processing agreement Terms of use Occupational Safety and Health Site Map Hot line: 8-800-333-43-76 Call within Russia is free © 2015 GEROPHARM Site development : TRINET Development