Risky Business

Abstract:The early 21st century has seen regulators and industry personnel shift pharmaceutical quality control from final-product sampling to the use of quality tools. Microbiological control in the pharmaceutical industry has operated under risk management principles since the 1950s, so the adoption of quality by design principles by the larger pharmaceutical industry has made microbiologists a crucial part of quality control. The new paradigm involves controlling microbiological contamination by adjusting design space and formulation, rather than waiting until a finished product can be sent to a microbiological lab. Includes examples of process analysis, value stream analysis, failure mode and effects analysis and matrix diagrams applied to pharmaceutical …

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Great article. Extremely informative and insightful outlook on the use of quality engineering tools by a pharmaceutical microbiology lab.
--Eoin Duff, 07-07-2011

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