Innovations

Yasenka is a combination of experience, knowledge and determination which make the difference in the market.

33

ACTIVE PRODUCTS IN 25 FORMS

6

IN PREPARATION

4

IN RESEARCH

We continously and systematically monitor market trends, projects and behaviour of end customers to obtain current information which is necessary to understand and adjust to the market today. We are aware of the importance of research due to complexity of the market and constant changes which take place. Therefore, investigation into research is at the top of our priorities.

Research makes an organisation unit with the aim to develop new and improve existing products or services, find new use value for old products or services and to improve and develop existing manufacturing, i.e. technological business processes. Each good idea, project and business start with end customers, their needs or desires. It is our task to recognise your needs and desires – and to always offer the best solution.

STANDARD I KVALITETA

Our advantages

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.

MODERN TECHNOLOGY

Our
strength

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.

Fully adjusted to production premises, it fits the automated system for production, filling and packaging liquid non-sterile forms. Production of semi-solid forms is performed on the vacuum mixer with rotor stator homogenizer which ensures production of all semi-solid forms in accordance with the requirements of Good Manufacturing Practice and the production following the latest trends in cosmetics.

Manufacturing equipment was purchased from the world-known manufacturers, and equipment qualification is conducted in accordance with the requirements of Good Manufacturing Practice. All processes are performed in accordance with the standard operative procedures and manufacturing documentation. Product lines are cleaned via CIP (“clean in place”) system.

The factory has installed system for production and distribution of clean compressed air and the system for production and distribution of purified water which are validated and controlled.

STANDARDS TESTING

Modern laboratory

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.

METHODS, ADJUSTMENTS AND MONITORING

Quality assurance

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.

Responsible persons for batch release ensure:

(a) for medicinal products manufactured in EU member states – that each lot of medicinal product is manufactured and verified in accordance with applicable law in that member state and requirements from the approval for marketing medicinal product;

(b) for medicinal products from third countries – that complete quality testing was performed for each manufactured lot in EU member state the medicinal product is imported into which ensures quality of medicinal products in accordance with the requirements from the approval for marketing medicinal product.