TriplePharm
JLLC is a modern pharmaceutical enterprise built in 2008 in accordance with the requirements of the Good Manufacturing Practice (GMP) rules, labor safety rules and standards, as well as sanitary and hygienic requirements for the manufacturing of medicinal products.The total area of the enterprise’s
premises is 3,500 m2 and includes all the infrastructure necessary to ensure the manufacturing of medicinal products: warehouses for storing raw materials, materials and finished products, manufacturing sites, physicochemical and microbiological laboratories, air and water treatment systems.
All technological processes
in accordance with international requirements for the manufacturing of sterile antibiotic powders are carried out in premises of cleanliness classes A, B, C and D on modern high-tech equipment from well-known companies in the global pharmaceutical industry from Belgium, Germany, Sweden, South Korea, Italy and other countries. Technical air and water treatment systems ensure round-the-clock monitoring and automatic regulation of the main parameters in clean rooms: temperature, humidity, pressure drops and air flow rate. Qualification of clean rooms, process equipment and technical systems was carried out by Lab & Pharma Engineering, Ltd., Czech Republic.The company has implemented, effectively operates and is constantly improving a pharmaceutical quality assurance system, which was developed in accordance with the requirements of national standards TССP 030-2013 (02040) Good Manufacturing Practice.
All technological processes and quality control methods undergo a validation procedure
- a set of measures proving that the process carried out within the established parameters is effective and with reproducible parameters, manufacturing a medicinal product that meets all specified requirements. The enterprise has a successfully functioning system of external and internal audits. A set of measures systematically carried out by the quality assurance department allows to guarantee the release of high-quality products that meet the requirements of the approved regulatory documentation and consumer expectations in terms of efficiency and safety.Modern laboratory equipment
allows for a wide range of laboratory tests and ensures the reliability and objectivity of the tests. Finished products are subject to sale only after documentary confirmation by the Qualified Person of the enterprise that the batch of finished medicinal product was manufactured and controlled in accordance with the requirements of the registration dossier and standard operating procedures. Product quality is a priority for all employees of the company, and we do everything possible to ensure that TriplePharm is associated by patients and healthcare professionals with high-quality and affordable medicinal products that allow the level of patient treatment to be brought closer to the highest healthcare standards.
