Risk Management in the Pharmaceutical Industry

This present issue of GMP REPORT contains papers dealing with selected aspects of risk management concerning pharmaceutical enterprises. Methods and tools are described with the industry-specific environment of their use. But the topic is dealt with not only from the point of view of pharmaceutical companies and not only by authors thereof. One article comes from an authority representative and describes an example of risk-based inspections by authorities. Another specialised paper lets the reader learn about the use of electronic data processing tools, their advantages, limitations and impacts. This GMP REPORT will also illuminate some of the details and peculiarities arising from the real-life practice of risk management in the pharmaceutical industry, authorities, suppliers, consusltants, etc., often not clearly regulated by official documents. Here the reader can profit from the vast experience and knowledge of the authors.