April 28, 2016
In
GMP Guidance Document, Out of Specification
Guide to Out of Specification Analytical Results
This free to download guide provided by Pharma Quality Partners Ltd, aims to summarise the current EU-MHRA and US-FDA requirements with respect to investigation of Out of Specification Analytical Results and provide you with the information you need to assure your OOS process is designed to achieve valid analysis results on which to base accurate quality decisions. Select Link Below to access the entire 14 page guidance document.
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