Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...
A critical control point is a step in the process of manufacturing or preparing food in which the right procedure can minimize or remove a potential health hazard such as a food-borne illness. By ...
Critical quality attributes, process and change control, product variation, characterisation, and regulatory concerns Sales of biologics grew by 20% in 2007, far faster than sales of small molecule ...
Throughout any given year, the National Academies convene hundreds of conferences, workshops, symposia, forums, roundtables, and other gatherings that attract the finest minds in academia and the ...
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Ppk: A Critical Component of Quality Management Systems
Ppk stands for Process Performance Index and is used for long-term variability. Ppk is a performance index that is used to ...
Optimizing the clarification of cell culture or fermentation broth is generally seen as a limited contributor to critical quality attributes (CQA). Researchers at Merck, however, say it’s time to ...
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