Setting New Production Standards PDF Print E-mail
Friday, 08 May 2009 06:31

 

The doctors, scientists and technicians involved in the manufacturing process are among the most heavily trained of all professions. This extensive training is required due to the production process for pharmaceuticals being one of the most precise and regulated activities in the world.


Balkan Pharmaceuticals was formed in the Republic of Moldova, basing its operations on the CIS system of quality control. Under this standard, the reliability of all laboratory investigations of pharmaceutical substances, auxiliary substances, packing materials and finished pharmaceuticals is tightly controlled and monitored to one of the industry’s highest standards.


Our company has its own laboratory for the testing and assurance of quality control. We use a strong mix of contemporary equipment, mandatory quality level expectations, and standardized operational procedures to establish some of the highest product quality results in the industry.


Our laboratory is equipped with state-of-the-art equipment. Amongst the equipment we use we have both Agilent 1200 chromatograph for high-performance liquid chromatography, an Agilent 8453 UV-VIS spectrophotometer for gas-liquid spectrophotometry, and an Agilent 6850 chromatograph for gas-liquid chromatography to test and authenticate the quality of our injectable products.


There is also the equipment for determination of disintegration and dissolution of capsules and tablets manufactured by Electrolab India (www.electrolabindia.com) of which we are the exclusive distributor for in Moldova, that allows to speak with confidence about high bioavailability of medical products manufactured at BALKAN PHARMACEUTICALS Ltd.


Chemical testing of our products is performed utilizing reagents produced in Europe (by Merck KGa , and Sigma-Aldrich Corporation) to ensure the quality of our pharmaceuticals as meeting European pharmacopoeia standards. In our efforts to meet and surpass these standards, we authenticate not only the quantitative value of the active constituents in the pharmaceuticals, but also of the potential impurities and other quality indicators. We combine the highest standards of European and American pharmacopoeia along with our own quality expectations to establish documentable analysis standards which have been approved and affirmed by the Agency of Medicines of the Republic of Moldova.


These standards have allowed us to create a successful enterprise, built on an internationally recognized system which guarantees quality, safety and reliability of our products. The reliable combination of our high production standards, our analytical processes, and the quality of our equipment are far from being the subject of doubt.


Our controls over the quality of our pharmaceuticals begin from the quality of our starting supplies and choice of packaging materials. The quality and integrity of each item is tested from the moment it enters our facility and is retested throughout the manufacturing process to the final pharmaceutical product.


Before production, samples of each pharmaceutical substance production series and completed pharmaceutical products passes an additional quality control certification process by the Agency of Medicines in the government of the Republic of Moldova as a final check of its quality and reliability.


Our laboratory staff members have extensive work experience in medical quality control and continue to seek improvement of their education not only within the Republic of Moldova, but throughout the world. This dedicated view results in a continuous improvement in the professionalism, experience, and educational quality of our staff.


Balkan Pharmaceuticals proudly bears the responsibility for assuring the quality of our pharmaceuticals and is ready to produce the documentation confirming the quality and reliability of our pharmaceutical products.

 

 
Russian (CIS)Ukrainian (Ukraine)English (United Kingdom)