Method development and validation

The development of reliable analytical methods for the testing of raw materials and intermediate and finished products requires highly qualified employees with many years of experience as an analyst. In our modern facilities, we develop methods for quantitative and purity analyses as well as identity and limit tests. After the method has been developed, it can be validated as required according to the European ICH Q2 (R1) guidelines (CPMP/ICH/381/95 and CPMP/ICH/281/95: Terms and Methodology) and according to customer-specific requirements.

Depending on the analytical method, the following criteria are considered during the validation procedure:

  • Linearity
  • Precision (repeatability, intermediate precision)
  • Accuracy
  • Specificity and selectivity
  • Robustness (influence of critical parameters, stability of solutions)
  • Limit of detection and quantitation

Data evaluation and determination of statistical parameters is performed using the latest version of the software VALIDAT (iCD System GmbH).

Your specifications are always taken into consideration during the preparation of the validation protocol and report.