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By Allan Marinelli and Howard Mann | All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a three-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies. |
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By Beth Fulton, Patrick Mains, and Kelly Waldron, ValSource Inc. | Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid. |
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By Samantha Atkinson, NSF | Quality management maturity is an important new trend in the biopharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol. |
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