25.08.2009

Without any adverse effects

By: Stephan DeMaria

Midsize pharmaceuticals company Vetter completely replaced several legacy systems and migrated to SAP ERP in an instant changeover. As a result, Vetter has gained more functions and great advantages through integrated processes.

Vetter Pharma-Fertigung is a leading independent manufacturer of aseptically prefilled application systems such as syringes, cartridges, and vials. Within this field, the company specializes in fill-and-finish services for high-quality biotechnologically produced drugs. At four production sites, around 1,900 employees complete orders for customers from the pharmaceutical and biotechnology industries, including many of the world’s major drug companies.

Vetter supports its customers in all product phases – from product development through regulatory approval to successful launch and supplying the global market. The company’s innovative, patented application systems can give partners a decisive head start with their products on the market.

Pharmaceuticals manufacturers and suppliers are permanently monitored by authorities and by their customers in accordance with the strict cGMP regulations (current Good Manufacturing Practice regulations updated annually and enforced by the U.S. Food and Drug Administration assuring the quality of processes and environments in the production of drugs) and the FDA requirements of 21 CFR Part 11 (the rule that allows the use of electronic records and electronic signatures). “Complete process transparency and professional quality management processes are imperative here,” says Titus Ottinger, head of Financials, Controlling, and IT at Vetter. “That’s why information technology plays an important role.”

By means of audits, the ordering parties check whether Vetter has met and documented the internationally binding specifications for manufacturing and the agreed process parameters. “In addition, government agencies of countries that import our goods inspect us to verify that we conform to their regulations,” Ottinger adds.

Although these regulations are essentially the same throughout the world, each agency and each customer interprets them differently and derives its own specifications from them. “Such are the conditions under which we produce. At the same time, we have many customer projects and continuously develop our range of products. What’s more, we also offer a comprehensive consulting package,” Ottinger continues.

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