Reducing Microbiological Risk and Using Quality Tools in the Pharmaceutical Industry
Posted on December 11, 2014
By: Donald Singer, Global Lead Quality Manager, Microbiology R&D
GlaxoSmithKline
Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuable methods. In the highly regulated...
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air monitoring, aseptic filtration, bacterial, bacterial endotoxins, bioburden, chromatography, Design of Experiment (DOE), drying, fermentation, filtration, filtrations, Low endotoxin water, microbial, microbial contamination, microbial growth, microbiological purity, Microbiological Risk, microbiologically, microbiology, microorganisms, Mycoplasma, non-pyrogenic, non-sterile process, not parenterals, ophthalmics, pre-sterilised, Purified Water, pyrogenic, quality by design (QbD), selected media, separations, solvents, sterile, sterile filtration, sterile products, sterility assurance, sterility test, terminal sterilisation, topicals, viral, Water for Injection
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