Quality Division

A business can build its goodwill as a reliable partner only if it provides an appropriate quality for its products or services.

About the Division

Quality assurance of medicines is a top priority for Mabscale, LLC. The Company’s pharmaceutical quality system ensures the supply of high quality, safe, and effective products that meet all applicable regulatory requirements and good manufacturing practices (GMP) of the Eurasian Economic Union.

Compliance with the regulatory requirements is a mandatory part of our quality control system based on the principle of quality risk management and our commitment to continuous improvement.

Maintaining the required personnel skills, taking into account all the existing requirements and development prospects, continuous training and mastering of advanced methods are the main prerequisites of successful divisions’ operation.

About

Quality Control Department (QCD)

The QCD is an independent structural entity (it includes a pool of inspectors and a control and microbiological laboratory). The division is staffed with experienced specialists with higher or secondary professional education.

QCD’s functions:

  • Control of raw materials and supplies, cell banks;

  • Production control (in-process control) at all stages;

  • Quality control of finished products;

  • Monitoring of clean media and rooms.

Monitoring

Monitoring is carried out to confirm the quality of preparation of engineering media, the production environment, personnel, and equipment. The critical points, their number and control frequency, has been selected based on the qualification and validation of every component using a risk-based approach.

The assessment is carried out by physical, chemical, and microbiological indicators.

Constant analysis of the data obtained allows preventing going beyond the valid condition.

The division is equipped with all the necessary modern laboratory facilities of famous world brands (Testo, Retsch, IKA GmbH, Nabertherm, BioSan Ltd, etc.); in the course of analyzes, it uses standards and reagents of the world’s best brands (Merck KGaA, Sigma, PanReac Applichem ITW Reagents, etc.).

Control laboratory

The laboratory surface area is 110 sq.m.

The division is responsible for the quality control of raw materials and supplies, the in-process control, the quality control of finished products; it studies the stability and shelf life of medicines according to the approved and validated methods.

The laboratory is equipped with modern liquid chromatographs (Shimadzu), systems for capillary electrophoresis (Lumex), spectrophotometers (Thermo Scientific, Shimadzu), and general laboratory equipment (Mettler Toledo, IKA GmbH, Thermo Scientific, Eppendorf, Bio-Rad, Sartorius, Biosan, Elmi) for chemical, physicochemical, and biological analyzes.

Microbiological laboratory

The laboratory area is 232 sq.m. The microbiological laboratory carries out its activities in strict accordance with the rules SP 1.3.2322-08 “Safety of Work with Microorganisms of the 3rd and 4th Groups of Pathogenicity (Hazard) and Pathogens of Parasitic Diseases” on the basis of a license for activities using causative agents of infectious diseases of humans and animals and genetically modified organisms of the 3rd and 4th classes of potential hazard, being carried out in closed systems.

The microbiological laboratory staff conducts tests of microbiological purity, the sterility of finished medicines, raw materials and supplies. In addition, the laboratory carries out full sanitary control of the production environment, engineering (technical) media, and personnel.

Quality Assurance Department (QAD)

The Company has developed and introduced a pharmaceutical quality system, the operation and maintenance of which is based on the following requirements:

  • Good Manufacturing Practice of the Eurasian Economic Union;
  • ICH Guidelines (Pharmaceutical Quality System);
  • ISO 9001 series standards.

The quality system covers all the stages of the medicinal product life cycle: development, production, storage, sales, and pharmacological supervision.

The personnel training maintains the required level of employees’ skills, including those of prompt and accurate performance by each employee of the tasks assigned to him / her. The daily operations and training activities are designed taking into account the production specifics, the Company’s development strategy, and innovations in production processes.

To confirm the stability of existing processes and the suitability of applicable specifications, and to find opportunities for product and process improvements, the Company has developed a standard for preparing reviews of the finished product quality.

The integrated management system includes a set of measures that guarantee the manufacture of high-quality, efficient, and safe products.

Validation and Qualification

The Company checks and evaluates all the elements of the production cycle to confirm its ability to consistently manufacture the finished product. For this purpose, it carries out validation and qualification activities (DQ, IQ, OQ, PQ, PV) in order to document the fact that equipment, systems, premises, production conditions, processes (drug manufacturing processes; processes carried out under aseptic conditions; cleaning procedures), control methods, and the product quality do meet the current requirements of regulatory and technical documents.

Monitoring the critical parameters of the production process and stable operation of equipment are ensured using measuring instruments by renowned world manufacturers such as Testo SE & Co. KGaA, Drägerwerk AG & Co. KGaA, Merck KGaA, etc.

Pharmacological supervision

Mabscale, LLC pays great attention to drug safety control. The Company has a pharmacological supervision system operating in line with the Good Manufacturing Practice (GMP) of the Eurasian Economic Union.

If you have any suggestions and/or questions regarding the quality, efficacy, and safety of medicines, or if you find any adverse reactions to medicines produced by Mabscale, LLC, contact us by phone: +7 (987) 459-99-95 or by filling in the feedback form and sending it to the Company’s email or postal addresses below

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