Process validation is a systematic approach used to ensure that a manufacturing process consistently produces products meeting predetermined specifications and quality attributes. It involves a series of documented activities that confirm the reliability and effectiveness of the production process throughout its lifecycle. By establishing robust validation protocols, organizations can mitigate risks, enhance product quality, and ensure compliance with regulatory standards.
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The IQ OQ PQ process validation methodology, standing for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) sequence
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