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Articles By steve gray stevenson
An Overview Of The Essentials Of Test Method Validation
By: steve gray stevenson
Even though the unique concept of test method validation is reliant on good science, the expectations which are posed as the test methods in the pharmaceutical industry was only validated and established as a benchmark by the USP in the 1980s and with its subsequent expansion as a renowned international expectation for the pharmaceutical industry, along with the publication of ICH Q2 that happened in the mid 1990s. Both USP and ICH Q2 are best used to classify test methods that are employed in the industry into various types, which are based on its intended usage and the identification of the characteristics that are considered in the unique validation of each kind of method.(read
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