The new Lek Quality Control Center in Ljubljana – Sandoz investments in Slovenia continued

“In pharmaceutical industry, quality assurance is one of the pillars of the process of drug development and manufacture. Producing safe, effective and high-quality medicines as well as improving the health and well-being of the patients are the basic guidelines of our operations,” said Neva Mikoš, Head of Lek Quality Unit, at the center opening ceremony.

The new Center will employ more than 100 people, mostly experts in pharmacy, chemistry and microbiology. The design of the facility follows the need to join the laboratories together in one room on each floor. “Compared to the old building, the new one enables a better utilization of space and improves communication paths. The disposition of the laboratories is in line with the process of analysis performed in accordance with the principles of lean manufacture, enabling a better organization of work operations. As much as 70% of the entire surface of the facility is occupied by laboratories,” said Katjuša Kreft, Head of Quality Unit Finished dosage forms at Lek, adding that in the construction of the new Center great emphasis was placed on ensuring a safe and healthy work environment.

The ground floor of the building houses laboratories for the control of raw materials, on the second and third floor there are laboratories for regular testing of products and finished products as well as laboratories for stability testing and for the testing of samples for validation studies of manufacturing procedures. In addition, the first floor houses the EU competence center where Sandoz products manufactured outside EU are tested and released to the EU markets. A new microbiological laboratory on the third floor of the new Center is another important feature. It enables the application of a new, advanced method of sterility testing, excluding the possibility of secondary contamination of samples and thereby increasing the reliability of test results.

“The Quality Control Center is a commitment to Ljubljana on the part of Sandoz and reflects the excellent levels of compliance demonstrated by the Slovenian organization throughout many international health authoriy audits,” comments Santiago Alonso, Head of Global Quality Assurance at Sandoz.

Quality control forms part of the process of drug manufacture

Before drugs enter the market, they have traveled a long, demanding way. Quality control, performed at all the stages of drug manufacture, definitely plays an important role in this process. It first starts with the raw material tested and released into production before the start of the manufacturing process. During the manufacture, samples are taken to perform testing and analysis of finished products. Before entering the market, drugs have to obtain final approval of conformity. To ensure stability and appropriate storage of drugs throughout their shelf lives, primary packaging and printed packaging are also of great importance. Consequently, all the packaging elements need to be checked before the packaging process is started. Only after the conformity of the product is tested, the product can be released to the market.