Data integrity in pharmaceuticals plays an important role in the quality of production. USFDA inspectors focus on data integrity in the manufacturing facility.
Details: https://www.pharmaguideline.com/2018/09/importance-of-data-integrity-in-pharmaceuticals.html
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Quality by Design (QbD) is a hot topic in the pharmaceutical industry, heavily promoted by the FDA. However, these tools should be used by every industry interested in producing high-quality products. The general concepts are not new, but the tools to implement them have dramatically improved in the last few years. This presentation provides a briefing on QbD along with state-of-the-art response surface methods (RSMs) for developing a robust design space.
