Quality control and assurance from the development to the production of biopharmaceuticals.
Consumer and patient safety have become the prerequisites for (bio)pharmaceutical product development, production and marketing. The ability to provide an effective, pure, safe product is the primary factor determining the product's success. However, with an ever-increasing number of national and international regulations, 'quality assurance' has acquired a threatening ring for many project managers. Many think that ensuring and improving quality is expensive, but regulations aid public acceptance. Good manufacturing practice can be developed into a business asset and need not be seen as merely a regulatory hurdle.
Doblhoff-Dier
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Institute for Applied Microbiology, University for Agriculture, Muthgasse 18, A-1190 Vienna, Austria. doblhoff@edv2.boku.ac.at
Bliem
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D015195:Drug Design; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D005060:Europe; D017408:Guidelines as Topic; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States