Manufacture

JLLC "TriplePfarm" is a modern pharmaceutical enterprise created in 2010 in accordance with requirements of Good Manufacturing Practices (GMP), rules and standards of labor safety and also sanitary and hygienic requirements to production of medicines.

The total area of enterprise premises makes up 3,500 sq.m and includes all infrastructure necessary to ensure production of medicines: warehouses for storage of raw materials, materials and finished products, production sites, physical-chemical and microbiological laboratories, air handling and water treatment systems.

JLLC "TriplePfarm" produces medicines on a full production cycle and specializes in production of powders of latest-generation antibiotics for parenteral use. 

All technological processes in accordance with international requirements to production of sterile powders of antibiotics are carried out in premises of A, B, C and D ranges of purity on modern hi-tech equipment of known companies of world pharmaceutical industry from Belgium, Germany, Sweden, South Korea, Italy and other countries. 

Technical systems of air handling and water treatment provide round-the-clock monitoring and automatic control of key parameters in clean premises: temperature, humidity, pressure and air flow rate.

Qualification of clean premises, processing equipment and technical systems is made by company "Lab & Pharma Engineering, Ltd.", Czech Republic.

All medicines are produced by highly skilled personnel having the relevant education and experience in pharmaceutical branch. For the purpose of professional development the personnel of the enterprise regularly takes internal and external training.

The quality insurance system is introduced, effectively functions and constantly improved at the enterprise. This system was developed in accordance with requirements of national standards TKP 030-2013 (02040) "Good Manufacturing Practice". 

All technological processes and methods of quality control are validated - a complex of measures proving that the process carried out within the established parameters proceeds effectively and with reproduced parameters, producing a medicine conforming to all specified requirements.

The system of external and internal audits successfully functions at the enterprise.

The purpose of external audits of producers (suppliers) of raw materials and materials, and also third-party organizations working on terms of outsourcing is check of compliance of organization of production to requirements of GMP/ISO and supply of products and services of guaranteed quality.

Internal audits (self-inspections) are carried out for the purpose of assessment of efficiency of functioning of the pharmaceutical quality system. 

The complex of measures which are systematically carried out by the quality insurance department gives the opportunity to guarantee the production of qualitative products which conform to requirements of approved standard documentation and customer expectations regarding efficiency and safety.

Testing laboratories of the quality insurance department of the enterprise (physical-chemical and microbiological laboratories) accredited on compliance to STB ISO/IEC 17025 requirements exercise careful control at all stages of a production process:

• input quality control of raw materials and materials,

• stage-to-stage control of a production process,
• control of cleaning of equipment and premises,
• control of sanitary and hygienic parameters
• outgoing quality control of finished products.

Up-to-date laboratory equipment gives the opportunity to conduct a wide range of laboratory researches and provides reliability and objectivity of carried-out tests.

Finished products are subject to realization only when the Authorized officer of the enterprise confirms documentary that a series of a    finished pharmaceutical product has been produced and checked in accordance with requirements of a registration dossier and standard operation procedures.

Quality of products is a priority task for all company employees, and we do the best to make TriplePfarm enterprise associated at patients and health care professionals with high quality and budget friendly medicines giving the opportunity to approach the level of treatment of patients to the highest standards of health care.