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Labcompliance News, May 2000

May 22, 2000

Tutorial on method validation

Method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Methods need to be validated or revalidated
before their introduction into routine use. Whenever the conditions change for which the method has been validated, e.g., instrument with different characteristics whenever the method is changed, and the change is outside the original scope of the method.

Labcompliance has a section on method validation with an updated tutorial. It describes the regulatory background and method characteristics as defined by the United States Pharmacopoeia (USP) and the International Conference for Harmonization (ICH). Finally it includes a step by step implementation guide. For convenient and trouble free implementation you also can download a standard operating procedure for method validation from the Users Club section.