Quality

Quality system at the production site

• Development, production and quality control of medicinal products (Quality, Safety, Effectiveness)
• Achievement of quality through observance of quality system rules including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
• Clear division of responsibilities and liability of staff. Full involvement of staff in creation of quality system
• Enough of trained staff at all the levels
• Compliance of the quality system with the national and international legislation
• Readiness to take into account all the remarks made by competent agencies during inspections
• Introduction of advanced technologies and newest control methods.

​Project on labelling of medicinal products

Quality Policy

Our mission:

by developing technologies of the industry and manufacturing effective medicinal products, we create better future.

Our main purpose:

development, production and release of high-quality, effective and safe medicinal products in accordance with the legislation and normative documents as well as expansion of the markets to sell products of the company in the Russian Federation and in neighboring countries and those further abroad and exploration of new segments of the market.

To reach the main goal and to constantly improve its activities the company developed, introduced and maintain Quality System (hereinafter referred to as QS) in a functioning state. It includes Pharmaceutical Quality System (hereinafter referred to a PQS), based on legislative requirements, GxP Rules (Russian Federation and EAEU) and ISO 9001.

Basic principles introduced to reach the main goal:

• Process approach – description of the company’s activities as a system of interconnected processes.
• Risk-oriented approach – identification of risks and opportunities sources, implementation of opportunities, analysis of the risks identified and adoption of measures to eliminate them, reduce and minimize.
• Responsibility of the executives – a duty to maintain QS (PSC) taking into account the assessment of its efficiency, readiness to provide necessary resources.
• Arrangement of development processes, production, production control, storage and distribution of medicinal products in accordance with GxP requirements (Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)).
• Involvement of the staff – commitment to the company’s values, development of personal competences.
• Monitoring of the company’s external environment – working only with the approved suppliers of raw stock, materials and services, analysis of compliance with consumers’ demands.

Necessary means to reach the main goal:

• Resources available: human resources, financial resources and infrastructure (including monitoring and measuring tools), necessary to reach the goals.
• Clear division of responsibilities and liability of staff.
• Continuous training: development of staff and their competences.
• Management of the company’s knowledge to make the products meet consumers’ demands.

The company’s executives takes a responsibility to implement the Quality Policy for continuous improvement of QS (PQS) and stable development of the company.

Quality assurance

The company has developed a functioning system for staff training embracing all the staff involved in production of medicinal products, storage thereof, quality control and assurance, assurance of proper functioning of technical systems at production sites, etc. There are documented regulations concerning training programs, training sessions, assessment of training efficiency.

To confirm continuity of the processes available, compliance with the current specifications for original raw stock, to identify tendencies and opportunities to improve products and the process GEROPHARM executes product quality review every year.

The company takes validation measures in accordance with the basic validation plan to prove compliance of the critical processes with the requirements set. Thanks to its own park of the testing validation equipment GEROPHARM can qualify clean premises, engineering systems and the following equipment with its own efforts: thermostats, autoclaves, hot-air ovens, climate chambers, cooling machines; constitute a cartography of warehouses, etc.

Pharmaceutical quality system makes it possible to ensure, maintain and control compliance with the target indicators at all stages of the product’s life cycle.