The new Lek Quality Control Center in Ljubljana – Sandoz investments in Slovenia continued
- The new Quality Control Center provides support to the planned production expansion
- Built in accordance with the latest guidelines of Good Laboratory Practice
- The Center will house one of the three Sando’ EU Competence Centers
- A microbiological laboratory – an important feature of the new Center
- Investment in the new center: EUR 5.6 million
- The new Quality Control Center will employ more than 100 people
The pharmaceutical company Lek, a Sandoz company, today opened a new Quality Control Center in Ljubljana. Providing sufficient capacities for a planned expansion of the production of solid dosage forms and sterile pharmaceutical products at Lek, the Center will support the growth of Sandoz’ sales and manufacture.
“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.
Lek, a Sandoz company, is one of the pillars of leading world generics company Sandoz. It operates as a global development center for products and technologies, as a global manufacturing center for active pharmaceutical ingredients and medicines, as a competence center for the development of vertically integrated products, as a Sandoz competence center in the field of development and manufacturing of biosimilars and as a supply center for the markets of CEE, SEE and CIS, sales Slovenia and sales services for Sandoz global markets. Lek d.d. employs more than 3,000 people. For further information please consult http://www.lek.si
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of more than 950 compounds and sells its products in more than 130 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and EonLabs (US) In 2007, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.2 billion.
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout
the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.
For further information contact:
Katarina Klemenc Dinjaški
Lek Pharmaceuticals d.d.
Phone: + 386 1 580 22 43
Fax: + 386 1 580 24 32