A "deviation" in manufacturing is when manufacturing steps are changed in some way from the set guidelines. Production guidelines are very detailed based on supply contract specifications, product ...

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The author analyzes the study design, participation, and data pooling from a recent benchmarking study on pharmaceutical manufacturing and raises concerns about the process used and data collected in ...

There are constant references in the regulations to the Quality Management System, or QMS, expected to be in place at every GxP-compliant site. The QMS is generally described in the Quality Manual and ...