Innovations

Continuous monitoring and implementation of development of technology, new developments and insights in science and technology ensure constant competitiveness on the market and step-by-step bring us closer to the very top manufacturers in the pharmaceutical industry. By implementation of latest technologies in the pharmaceutical industry we try to continuously improve the quality of services and strengthen quality control and continuously educate our employees. Yasenka currently employs 34 workers, 23 with university degree (among them, one specialist in pharmaceutical technology and one specialist of testing and control of medicinal products) and they are continuously additionally educated. The factory Yasenka tries to follow global trends in the application of product technologies which do not harm the environment and adjusts its activities with the laws and regulations accordingly. Certificate ISO 9001:2008 is the confirmation of our business successes, and an impulse for new achievements.

Production in Yasenka is divided into three departments, depending on the pharmaceutical form: semi-solid, non-sterile liquid and solid oral forms. Production starts in the modern weighing room equipped with scales and a weighing chamber which ensures safety of starting raw material and employees in the production. While  weighing process is performed, the chamber above continuously directs air towards a set of filters, thus disabling cross-contamination of raw material and protecting operator while performing weighing. All premises in the production area in which the product is in contact with air meet the requirements of GMP class D, which means that the air is constantly filtered through highly efficient filters.  Temperature, humidity and pressure are continuously controlled in each separate area of class D via central system which, in case of deviation, alarms Technical service by text message alarm system at any moment.

Line for production of liquid forms enables safe and efficient production in a closed system.

Quality control includes physical-chemical and microbiological laboratory which conduct analysis of raw material and packaging material, intermediate products, finished products, compressed air, purified water and conditions in the production. Laboratories are equipped with the latest qualified laboratory equipment and instruments, which ensures obtaining reliable analytical results. Testings are conducted in accordance with specifications and analytical methods adjusted with the requirements of the European Pharmacopoeia and regulatory requests (directives, acts, ordinances, guidelines). Key processes of the laboratory of Quality control primarily include sampling medicinal substances and preparations, development of analytical methods, implementation of analytical testing, transfer of analytical methods, issuing an analysis certificate and monitoring stability of preparations. Main task is to obtain precise and accurate results of analyses which can later be used to monitor long-term results and possible changes.

Department of Quality Assurance, as all employees in Yasenke d.o.o., is responsible for defining, implementation, supervision and improving an efficient system of quality management in order to ensure supplying the market with high-quality products. Quality system in Yasenka d.o.o. is defined by Quality Assurance by a series of written standard procedures according to the scope of application.

Confirmation that the Quality system was successfully implemented was the receipt of a Good Manufacturing Practice Certificate in accordance with EU GMP and Directive 2003/94/EC, HACCP certificate for production of food supplements and ISO 9001:2008 certificate.
Decision on release of products on the market is reached by Responsible person for batch release based on the review of manufacturing documentation of a batch of medicinal product, results of laboratory analysis of a series of product, results of testing the conditions in production and the quality of energy sources.