Why do analytical test methods need to be validated?

23.06.2025

Question of the Week

The accuracy and reliability of analytical results are essential prerequisites for ensuring the quality, safety and efficacy of medicinal products. Test methods used in the GMP environment must therefore be suitable, i.e. validated, for the respective application. This suitability must be proven before initial use and must also be ensured for each use over the entire lifecycle.

[GMP Compliance Adviser, 14. D]

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