Quality control

The key goal of NGO Microgen is to produce competitive, high–quality, effective and safe biological medicines for medical use, including vaccines used to immunize the population within the framework of the National Calendar of Preventive Vaccinations, the Calendar for Epidemic Indications, and made in accordance with the regulations. For this purpose, the company has developed and implemented a Quality Policy.

The company's Pharmaceutical Quality System (PQS) allows us to ensure the quality of manufactured drugs throughout their entire life cycle and covers all levels of the production process, control, procurement and logistics. Quality management is based on compliance with the requirements of good manufacturing practice (GMP) and is continuously improved taking into account the risk-based approach and GMP requirements.

PQS includes the management of suppliers of raw materials, complaints management, deviation management, which includes the elimination of the causes of identified and suspected inconsistencies and the implementation of corrective measures, as well as the management of other processes on which the image of drugs, the company and consumer confidence depend.

Production sites of FSUE NPO “Microgen” support and regularly analyze the effectiveness of PQS, organizing annual product quality reviews, and also undergo the internal and external cross-checks of supervisory bodies of the Ministry of Industry and Trade of the Russian Federation, Roszdravnadzor, Rospotrebnadzor, confirming compliance with GMP requirements and readiness for development and improvement.

Key employees of the company are required to be trained in the requirements of good practices (GxP). The quality of the drugs is ensured by their high professionalism and skilled work with a focus on:

• A guarantee of stable quality of manufactured drugs;
• Preventing the use of materials or products that do not meet the requirements;
• High executive discipline;
• Improvement of production, introduction of modern technologies to ensure the organization of production in accordance with the current requirements of national and international standards;
• Staff development;
• Continuous review and evaluation of products, technological processes and control methods;
• Risk-based approaches and reduction of possible negative impact on quality;
• Planning to ensure the functioning of the PQS in accordance with the approved requirements;
• Analysis of the effectiveness of the functioning of the PQS by the management in order to improve it;
• Support management by providing the necessary resources to ensure that PQS meets the stated requirements.

The PQS operating at all NPO Microgen sites is managed by quality services, which include a quality assurance department and a quality control department. The services perform mandatory control of raw materials, intermediates, and finished pharmaceuticals for compliance with governing regulatory documents, registration dossiers, and specifications.

Each branch of the company has an authorized person who is responsible for the quality of produced and manufactured drugs and their circulation on the market.

Quality Policy

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Quality quide

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