The Quality Management System encompasses a set of activities whose systematic execution ensures that the quality of the manufactured products complies with the requirements of the approved regulatory documentation. The purpose of this system is to organize and maintain processes required to produce high-quality, effective, and safe pharmaceutical products.

The quality management system of a pharmaceutical enterprise integrates nearly all manufacturing processes, using tools such as validation, production monitoring, corrective and preventive action systems, and more.

The functioning of the pharmaceutical quality system is ensured by the quality department, which includes the quality control, quality assurance, and validation divisions. Headed by the Quality Director, the department is an independent structure and reports directly to the company's General Director.

The main provisions of the pharmaceutical quality system and compliance with GMP regulations are defined in the Quality Manuals and Quality Policies.

The production of pharmaceutical products is carried out in accordance with the requirements of the Russian Federation’s registration dossier, as well as quality standards established by industry and other national and international standards.

The production site holds a license for the manufacture of finished pharmaceutical products and a certificate of compliance with the Good Manufacturing Practice (GMP) requirements, as approved by the decision of the Eurasian Economic Commission Council No. 77, dated November 3, 2016, "On the Approval of the Good Manufacturing Practice Rules of the Eurasian Economic Union." To comply with GMP standards, the design, construction, and equipping of new, as well as the modernization of existing production facilities at PJSC «Kraspharma» incorporate advanced materials, technologies, and equipment from leading manufacturers such as "GEA," "Finn-Aqua," "IMA," "SHINVA," and "Austar."

At PJSC «Kraspharma» an internal documentation system has been developed, encompassing company standards, standard operating procedures (SOPs), and internal instructions in accordance with the requirements of Good Manufacturing Practice (GMP). All company personnel are trained in GMP principles to the extent required by their professional duties. To ensure this, a multi-level system of continuous education and periodic certification for all employees has been established. Additionally, all specialists undergo external GMP training at leading companies specializing in the training of good manufacturing practices and quality control of pharmaceutical products, taking into account global best practices.

The proper functioning of the pharmaceutical quality system is confirmed through regular internal and external audits.

All personnel at PJSC "Kraspharma" are trained in GMP (Good Manufacturing Practice) principles, in accordance with the specific requirements of their professional responsibilities. To this end, the company has implemented a multi-level system of continuous education and periodic certification for all employees.Employees at all levels regularly undergo external training at leading companies specializing in the training of pharmaceutical industry practices (sGxP), taking into account global expertise.

Quality control of each batch of raw materials, intermediate products, and finished products is carried out by specialists in the Quality Control Department (QCD), following approved methodologies and using modern equipment.



The QCD includes:

• Chemical Laboratory
• HPLC and GC Chromatography Laboratory
• Microbiological Laboratory
• Pharmacological Laboratory and Vivarium
• In-Process Control Group

Only raw materials and materials that have passed incoming inspection and received the status of "Approved for use in production" are allowed into the manufacturing process.

During production, monitoring of key parameters of manufacturing processes, environmental parameters (microbiological monitoring of air, equipment, personnel clothing, hands, and other parameters), and quality control of intermediate products are conducted. All premises, systems, equipment, processes, and methods undergo validation and revalidation, which are part of the quality assurance system and an integral part of the drug development process and its manufacturing technology.

Each batch of the medicinal product is released by the Authorized Person after a thorough review of the documentation for each stage of production and quality control. This ensures that the batch is produced in accordance with Good Manufacturing Practice (GMP) rules, with full quality control of the medicinal product, and complies with the registration dossier.

The Authorized Persons of PJSC «Kraspharma» are certified in the prescribed manner and are listed in the register of Authorized Persons of medicinal product manufacturers.

The Quality Service also handles the review of all incoming quality complaints regarding the manufactured medicinal product. In accordance with approved procedures, each complaint is registered and thoroughly reviewed. If the complaint is deemed valid, a corrective and preventive action plan is developed, and its implementation is strictly monitored and evaluated for effectiveness.

PJSC «Kraspharma» is proud that, for several years, there have been no complaints regarding the quality of the company's products from regulatory authorities of the Ministry of Health of the Russian Federation.

To ensure the quality of the products manufactured, the company operates a self-inspection (internal audit) system.

The objectives of the internal audit are as follows:

• Control and identification of deficiencies to maintain proper conditions for pharmaceutical production;

• Preparation of a detailed audit report to assess the effectiveness of the quality management system and identify opportunities for its improvement;

• Professional development of the company’s staff.