Equipment Qualification: A Practical guide to IQ, OQ, PQ, and DQ.

This Deep Dive, excerpts from "Mastering Equipment Qualification," offers a comprehensive overview of the essential equipment qualification (DQ, IQ, OQ, PQ) lifecycle within the pharmaceutical and medical device industries. It emphasizes the critical role of this process in ensuring product quality, patient safety, and regulatory compliance, referencing guidelines from the FDA and other global authorities. The document meticulously details each qualification stage, outlining their objectives, key activities, regulatory basis, and required documentation. Furthermore, it addresses the interrelationship between these stages, practical implementation strategies, and the importance of maintaining a qualified state through ongoing monitoring and change control.


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