By Joachim Ermer, Ph.D., GMP Compliance Adviser
Published in: Outsourced Pharma
Published on: July 7, 2025
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 life cycle.
The regulatory requirements for the analytical validation of test methods are described in ICH Guideline Q2(R2). Important key points for validation result from the method development described in ICH Q14, e.g., the analytical control strategy, robustness, or the use of development data in the validation strategy. Both guidelines should be considered together.
