Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes
Monday, January 1, 2018
Understanding the Three Stages of Process Validation
While most professionals know there are three stages of the process validation lifecycle, many are unaware of the activities dictated by each stage. As part of IVT's pre-Validation Week webinar, Paul Pluta, Ph.D., explained the prescribed endeavors of Stage 1, Stage 2, and Stage 3 of process validation as recommended by the US Food and Drug Administration.
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