Make Sure Process Validation Is Conducted By 'Qualified' Personnel, Experts Say
This article was originally published in The Gray Sheet
From our digital archives: Process validation activities must be conducted by “qualified” employees to ensure product quality, experts said. In general, manufacturers must show that individuals who perform process validation are thoroughly familiar with what they are validating, and that they have appropriate credentials. “There definitely is a technical level of confidence that is extremely important” in conducting process validation, Philips Healthcare's Elisabeth George said in September 2011. Further, firms must document that employees and consultants involved in validation meet FDA’s qualification requirement.
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