Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation.[1] The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design (Stage 1a, Stage 1b), process qualification (Stage 2a, Stage 2b), and continued process verification (Stage 3a, Stage 3b).
^"Guidance for Industry Process Validation: Generally Principles and Practices" (PDF). Food and Drug Administration. Retrieved 16 December 2014.
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