Overview: Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug d
November 11, 2020 - CA USCompliance4All
compliance4all14@gmail.com
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Overview: Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
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