Any analytical method applied to a pharmaceutical product under current Good Manufacturing Practices (cGMPs) requires validation. The methods used to produce data supporting the production of pharmaceuticals or regulatory filings (with FDA for example) need to be validated prior to use.
Validated analytical methods support a drug’s characterisation, quality control and manufacturing batch records. This analytical test method validation provides a documented process demonstrating that the test procedure is suitable for its intended purpose, provides evidence of the method’s performance and ensures quality and reliability of results.
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