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Alkaloid’s New Quality Control Center April 28, 2016

Pharmaceutical products are the most strictly and highly regulated category of products worldwide, and delivery of quality, effective and safe medicaments is the credo each serious pharmaceutical industry should follow. Rigorously controlled conditions for pharmaceutical production are the prerequisite for ensuring high quality medicines; hence, pharmaceutical quality control is an essential part of our manufacturing operations.

The principal concern and emphasis of the overall operations of PC Pharmaceuticals is aimed at ensuring production of high quality products that will fully meet the needs of the patients. To this end, in the past 18 years Alkaloid AD Skopje has allocated considerable investment funds in production capacities and the Institute for Development and Drug Quality Control. As part of this investment trend, today we officially commission the new capital facility: Centre for Quality Control, an investment worth over EUR 5 million.

The new Centre for Quality Control is a technologically-analytical facility with an area of 3,000 m2 in which the following activities take place: control of raw materials, contact and secondary packaging, control of phase production and finished products, microbiological control and stability of pharmaceutical products, validation activities and monitoring and preparation of analytical documentation for registration of pharmaceutical products.

To perform these activities, the Centre for Quality Control is equipped with: an input material laboratory, laboratory for pharmaceutical products, analytical development department, commercial series stability department, microbiology and a department for preparation of documentation for ongoing activities and for registration purposes. The Centre has 2 premises for storing stability specimens (each with an area of circa 35 m2), 2 premises for storing spare specimens (with a total area of circa 300 m2) and auxiliary administrative premises. Suitable working conditions are provided for proper functioning of the facility, such as: appropriate ventilation for maintaining constant temperature and quality of the air, a system for production and distribution of purified water, compressed air and other industrial media. The waste water system is appropriately managed, in accordance with the current European and world standards. The working conditions, from the aspect of workplace safety, are at the highest possible level, ensured with an aggregate SCAT system in the work stations and suitable safety cabinets for chemicals and gases.

The Centre for quality control will employ more than 100 highly professional executives, a quota which currently covers 26 new employments. 70% of the employees are with higher education and some of them are specialists and hold a master’s degree.

The presence of Alkaloid AD Skopje in the markets of over 30 countries worldwide and the continuous aspirations to open new perspectives requires careful following the demands of the rigorous world authorities in the fields of health and pharmaceuticals and their implementation in the daily working activities. The new Centre for Quality Control of Alkaloid AD Skopje confirms the strategic commitment of the company to produce quality, reasonably priced, safe and effective drugs made in compliance with the strictest world standards.



Category: Member News