Without any adverse effects

Feature Article | August 25, 2009 by Stephan DeMaria

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.

Migration on the fly

The orders are coming in thick and fast, business has been booming for years. But in the IT department, Vetter is beginning to find itself at a dead end. The system landscape comprised two different ERP applications, which came from two different providers to boot. At least one of the applications was no longer future-proof. “With frequent changes of ownership, no further development, functional gaps, major integration problems, and difficulties in acquiring new employees to administer the legacy systems, things simply couldn’t go on,” says Markus Thiel, head of IT at Vetter.

In a preliminary study on the implementation of a new ERP system, several alternatives were investigated. After thorough research, there was soon agreement within the company that SAP would be the solution of choice. According to Thiel, the classic arguments were the most convincing: end-to-end processes in a homogeneous, integrated system; transparency throughout the entire value chain; plus investment protection, process reliability, and system security in a highly regulated and sensitive business environment.

Working with IT service provider itelligence, Vetter went ahead with a big-bang migration to SAP ERP from the legacy systems PSI Penta and Ratioplan after just 15 months. At the same time, the highly sensitive and mission-critical interfaces to the warehouse management system and to the production-related weighing system were replaced, the SAP Supplier Relationship Management (SAP SRM) application and the SAP GRC Global Trade Services application were installed to provide new functionalities, and the stovepipe solution for project management and the laboratory information system functions were integrated with the SAP environment. Mastering these tasks was a fantastic achievement for the project team, says Max Horn, managing director of Vetter.

“We are especially proud that – in spite of initial skepticism – we managed to map our important and highly sensitive quality assurance processes in SAP and thus replace our longstanding laboratory information system,” says Dr. Bernd Renger, director of Quality Control. Laboratory information system – or LIMS – is the name given to special software used to manage, monitor, and document all activities in analytical and microbiological laboratories.

LIMS processes include taking and receiving samples, recording measurements, and performing analyses, as well making the final decision about accepting or rejecting a batch and collecting performance metrics to manage the financial side of the laboratory. This is a challenging task, which not all providers can meet to the same extent. “We neither had to deviate from the standard, nor did we have to forego previous functionalities,” says Renger. What’s more, Vetter gained new, more sustainable tools, such as one for creating digital signatures.

“We are highly satisfied with the success of the project and the functionality of the software. And we’re also well equipped to face the future,” Ottinger concludes. “We have gained a comprehensive view of all our company’s activities and can now identify potential for improvement.”

Vetter Pharma-Fertigung

For more than 25 years, Vetter has supported customers from the pharmaceutical and biotechnology industries in every phase of production, from product development through regulatory approval to successful launch and supplying the global market. The company is headquartered in Ravensburg, Germany, and employs around 1,900 people, who annually produce approximately 400 million production units.

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