| Quality Control |
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When Dr. Harald Schuhbaum is asked what his job is he answers without hesitation "head of control", and then adds after a fraction of a second, "qualified person." He explains, "That's the name assigned to my job under the reformed drug law." But the legal changes have had little effect on his work for the 35-year-old head of quality control at Bionorica.Harald Schuhbaum has wide-ranging responsibility for approval of the company's products. A burdensome job? "No," he says, his job is not at all burdensome. "Because I know our products and especially their quality." So what qualifications does one need to become a "qualified person" at Bionorica? "To have studied pharmacy - preferably finishing with a PhD - and at least two years experience in testing drugs," he replies. One look at Schuhbaum's choice for his doctoral work makes it seem as though he already had his present employer in mind.
He wrote his thesis on his investigations of extracts from ginger and their anti-inflammatory properties. The reason he is so interested in phytopharmaceuticals is quite simple. "Plants are extraordinarily complex," he says. "The sheer multiplicity of their molecules is a real challenge." The main responsibility of Dr. Schuhbaum and his team is to test all raw materials, auxiliary products, intermediates and extracts right through to the finished product. Do the raw materials truly contain the necessary ingredients? Do they only contain the substances that nature provided them with? Are the auxiliaries supplied to Bionorica the best quality? Do the finished extracts meet the prescribed specifications? And does the finished medicine meet all the necessary requirements? Many of the tests involved in checking incoming goods are very simple, considering that color and odor are easy to judge. However, the microbiological examination takes at least a week. The laboratory provides a first overview of the contents of a sample extract, the so-called fingerprint. But testing is not only a matter of time; the latest scientific techniques are also essential. These include high performance liquid chromatography, thin layer chromatography and gas chromatography. After all, quality cannot be judged by the nose, eyes and expertise alone. Measurement readings must go well beyond the decimal point to ensure the quality required of Bionorica's products. Sometimes a verdict can take a long time, as is necessary for stability testing. In this process some products can be kept for more than five years in special climate chambers, which are maintained at a prescribed temperature and humidity. "Here we deliberately exceed the legal requirements," says Schuhbaum, "because we want to provide patients - and ourselves - with the highest level of safety." His team today consists of 20 coworkers. Schuhbaum himself regards quality control as being at the hub of the organization because it has to work with so many different departments. Registration colleagues have to be supplied with documentation, processes are regularly tested for production managers, test procedures are discussed with analytical development, sales expect to receive the products on time and the development department creates new processes whose safety must be ensured from the very outset. So what does Harald Schuhbaum like best about his job? His answer comes without the slightest hesitation: "The great variety." Does that mean that things have to be changed so often? "No," he replies firmly. "Absolutely not." And here again there is a very specific reason. "We work on the basis that we deliver quality; we do not create quality by just testing for it." |