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PQ Forum: FDA Lifecycle Approach to Process Validation—What, Why, and How? | IVT

The US Food and Drug Administration issued Process Validation: General Principles and Practices in January 2011, which has given widespread visibility to the lifecycle approach concept. The process validation guidance integrates strategy and approaches to provide a comprehensive approach to validation. Three stages in the lifecycle approach are identified.  The lifecycle concept links development, validation performance, and product or process maintenance in a state of control during routine commercial production. Understanding the sources of variation and control of variation commensurate...

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