August 31, 2009

Pharmaceutical salt production at the Wintershall site passes the FDA’s examination successfully for the second time

Proven and certified quality that is quite impressive: The GMP system (Good Manufacturing Practice) implemented within K+S KALI GmbH’s Werra factory has been approved by the American Food and Drug Administration (FDA) for the second time. The FDA reports directly to the American Department of Health and ranks among the most well-known and strictest regulatory authorities in the whole world.

Three instead of four inspection days

“The FDA’s inspection corresponds approximately to the German tax authority’s inspection” says Joachim Hinke, head of quality management in the Werra factory. Already after three instead of four inspection days that had been arranged at short notice in March of this year, the pleasant result without any complaints was “accepted”. As the two FDA inspectors did not find any deficiencies, they left the Werra valley earlier than expected. Prior to their departure, they had thoroughly inspected buildings and plants, documentation and reports, packaging and labeling and the laboratory for the high-purity salts, amongst others.

Together they have achieved outstanding results: The enlarged QM team of the Wintershall site.

In the focus of American regulatory authorities

The FDA inspection on the Wintershall site was the second one after 2006. The inspection had been necessary because today K+S pharmaceutical products can be found in many drugs worldwide. “As soon as applications for the approval of new drugs in the US are presented, the producers of the ingredients get automatically in the focus of the American regulatory authority” explains Dr. Hinke. A deficiency discovered by the FDA results at least in a so-called 483, a written request for improvement. In case of worse deficiencies, the company gets listed on a negative list on the FDA’s web site and in the worst case, an import stop in the US might be the consequence.

Amongst others, the laboratory for high-purity salts has undergone a thorough examination within the framework of the inspection.

Quality as a trademark

“We are proud of the good work of the GMP team that had been enlarged for the inspection“, say the factory managers Peter Euler and Dr. Rainer Gerling. “Quality is more important than ever and it is the trademark of our company.” The central QM system of the Werra factory is not only certified according to FDA standards but also according to DIN EN ISO 9001:2000 by TÜV Nord. Moreover, the factory in Werra has successfully passed a GMP inspection for the production of pharmaceutical Epsom salt and high-purity salts carried out by the regional administrative authority in Darmstadt (Regierungspräsidium Darmstadt).

Successful teamwork

The responsible inspection team of 13 people is sure that the quality management’s outstanding development and quality in the Werra factory is the result of good teamwork: “This success is the outcome of the whole GMP team’s intensive work that had been going on for years” say Dr. Hinke and his colleague Birgit Werner “results like these cannot be achieved alone because only a well-coordinated team can deal successfully with a project that involves such a high amount of paperwork and requires a great deal meticulousness.”