PJSC "Krasfarma" has gained the reputation of a reliable and responsible manufacturer and supplier due to the proper quality of the products, which in their pharmacological and therapeutic properties are not inferior to the original drugs. Full confidence that the company produces high-quality safe and effective medicines at affordable priceslet the company win the confidence of both doctors and patients.

The quality of manufactured products is provided by a combination of a number of factors.They include equipping the enterprise with high-tech equipment, compliance with modern requirements for production activities and quality control of medicines specified in the GMP industry standard (GoodManufacturingPracticeforMedicinalProducts), the responsible attitude of all enterprise’s staff to their professional responsibilities and the desire for continuous self-development.

PJSC "Krasfarma" does not stop at what has been reached: so that the quality of medicines is at a consistently high level, the production process is constantly being improved, the most modern inventions are used to continuously improve products.

Product quality is a component of the philosophy of the Company. Optimization and continuous improvement of production processes allow us to improve and maintain the quality at a high level, thereby ensuring that the products produced by PJSC "Kraspharma" meet the growing health needs and increase the profitability of the enterprise.


The quality management system includes a set of measures, the systematic accomplishment of which guarantees the compatibility of the quality of the manufactured products with the requirements of the approved regulatory documentation. The purpose of this system is the organization and maintenance of the processes necessary for the production of high-quality, effective and safe medicines. The quality management system of a pharmaceutical enterprise unites almost all production processes and for this purpose uses such methods as validation, production monitoring, the system of corrective and preventive actions, etc.

One of the elements of the quality management system is the quality service organized by PJSC "Krasfarma". It monitors the technological processes of production, controls quality of coming materials, raw materials and ready products. The quality service, headed by the Quality Director, where highly qualified specialists with extensive experience work, is an independent structure under control of the General Director of the enterprise.

According to GMP standards (Good Manufacturing Practice) during design, building and equipping of new industries and already existing ones modern materials, technologies and equipment of such leading companies as “GEA”, “Finn-Aqua”, "IMA", "SHINVA", "Austar" are used.

PJSC "Kraspharma" has developed an internal documentation system, which includes the enterprise standards, standard operating procedures (SOPs), internal instructions in accordance with the requirements of Manufacturing Practice. Staff of the company has been taught the principles of GMP in the required way. Tothis end, the company has organized a multi-level system of continuous training and periodic certification of all employees. Moreover all the company's specialists undergo external GMP training in the leading companies specializing in teaching requirements of proper production and quality control of medicines, taking into account international best practices.

One of the main areas of quality assurance is the work on the selection of suppliers of materials, raw materials and services. Before the start of cooperation all suppliers of raw materials, packaging and marking materials, necessary equipment and production services are audited, and only after that they are entered into the List of Approved Suppliers. Such a well-established system of working with approved suppliers allows producing medicinal products of guaranteed quality.


All enterprise personnel are trained in the principles of GMP (GoodManufacturingPractice) in the amount of the requirements of its professional duties. To this end the company has organized a multi-level system of continuous training and periodic certification of all employees. Moreover all of the company's specialists undergo external GMP training at leading companies specializing in the training of the requirements of proper production and quality control of medicines, taking into account international best practices.


Quality control of each series of materials and raw materials, intermediate products, finished products is carried out by specialists of the quality control department (QCD) according to approved methods using modern equipment.

The structure of QCD includes:

  • Chemical Laboratory,
  • Laboratory of HPLC-GLC chromatography
  • Microbiological laboratory,
  • Pharmacological laboratory and vivarium,
  • Interoperational control group.

Only raw materials and materials that have passed the entrance control and received the status "Permitted to use in production" are allowed in the production process.

In the production process monitoring of the main parameters of production processes, environmental parameters (microbiological monitoring of air, equipment, personnel’s hands and clothesand other parameters) and quality control of intermediate products are carried out. All working rooms, systems, equipment, processes and methods are validated and revalidated. It is an element of the quality assurance system and an integral part of the whole process of drug development and production technology.

Entry of each series of the medicinal product is carried out by the Authorized Person after careful examination of the documentation for each stage of production and quality control. This ensures that the series is manufactured in accordance with the rules of Good Manufacturing Practice, with full quality control of medicines and complies with the registration dossier.

Authorized personsof PJSC "Kraspharma" are certified in accordance with the established procedure and included into the register book of authorized persons manufacturing drugs.

The quality service also deals with all incoming claims on the quality of the produced drug. According to the approved procedures, each claim is registered and reviewed in detail. According to the results of consideration, if the claim is recognized as valid, a plan of corrective and preventive actions is developed. The implementation of the plan is strictly monitored and the effectiveness of the taken measures is evaluated.

PJSC "Krasfarma" is proud of the fact, that there are no complaints of the quality of the company's products from the controlling structures of the Ministry of Health of the Russian Federation for several years.

Internal audit as a basis for maintaining the company’s quality system at the proper level

The company has a self-inspection system (internal audit) to guarantee the quality of products.

The aims of the internal audit are:

  • proper control and identification of deficiencies in order 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 improvement of the company’s team.

Internal audits are conducted in all structural units of the company involved in the quality assurance system for finished products.