Site MapКарта сайта

We are very glad to welcom you
on Web-server of LLC “Pharmtechnology”!

Quality System

At our plant we have developed and implemented a documented pharmaceutical quality system, incorporating all GMP factors. The Quality Assurance (QA) and Quality Control (QС) Departments ensure pharmaceutical quality system functioning, including management of all factors, which influence the quality, assurance of constant quality, prevention of non-conformances, assurance of correspondence with all requirements, and adequate control.

We have foreseen all measures concerning estimation and confirmation of the fact that the quality of produced medicines is maintained during the whole expiry period (stability program, storage of retention and control samples).

We perform log keeping of all procedures, processes, controls, execution of quality system methods, and among other things production and packing processes, and develop a “Batch Dossier” for each medicinal agent.

All products are sold only after passing all tests on correspondence with the set requirements and issue of a corresponding permit. Medicines sales permits are issued by the authorized person. The medicines quality during their storage, shipment and subsequent handling within the expiry period is ensured by the special comprehensive set of measures.

Responsibility for quality adherence is imposed on the whole enterprise staff. Performance efficiency of pharmaceutical quality system is evaluated by self-inspections. Good efficiency level maintenance is provided by the system of implementation of preventive and corrective activities.

Pharmaceutical quality system includes the following obligatory components:

  • document management system
  • staff training system
  • management of changes system
  • deviations monitor system
  • system of risk management
  • quality review
  • supplier relationship management

Competent personnel with appropriate education and adequate work experience in the area of production and/or quality assurance and quality control holds key posts at the enterprise.

Training staff system has been formed and works successfully. It encircles all employees engaged in medicines production, their storage, quality assurance and quality control, provision of production sites’ engineering systems appropriate operation.

The premises and facilities are designed and operated according to the requirements applicable to the manufacture of drug products. The premises, where the drug products are stored, manufactured and where quality control is performed, are made of appropriate finish materials.

There are separate physical and chemical laboratory and microbiological laboratory equipped with modern high class control and measuring instruments such as spectrophotometers, liquid and gas chromatographs Agilent, Fourier-infrared transform spectrometer “Nicolet 380”, viscosimeter BROOKFIELD LV DV-E, Titration System “TitroLine alpha plus” and dissolution apparatus for tablets ERWEKA DT700LH, Tablet Friability apparatus and automatic polarimeters, etc.

One of the main strategic priorities for Pharmtechnology LLC was to maintain its leading positions in the sphere of product quality, as operation of the pharmaceutical enterprise according to the international standards reduces the risk of errors occurrence, guarantees high quality level of output products, provides safety products for the consumer, allows the enterprise to cover the requirements of its domestic market in medicines in full, as well as to export its products to various countries around the globe.