What is the difference between method verification and method validation?
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pharmamanufacturing Manufacturing Community Member 151 Posts
Re: Verification vs Validation27 October 2015 at 4:11pm Last edited: 27 October 2015 at 4:12pmIt’s not that well-known that method validation is a much more rigorous process than method verification. What’s really needed, more likely, is the establishment of a verification regime that assures analytical methods perform reliably, accurately, and precisely for its intended application.
Method validations are performed for new methods that have just been developed, and that require revisions because they've been significantly changed. Method verification is materially different and a little more limited, and not as robust as a method validation. Method verifications are really performed for compendial methods, where there's already an existing method in a compendia, like USP, NFBP or EP. It is showing or proving that a given lab is capable of performing that particular test reliably and precisely.
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