Analytical Method Qualification & Validation

Method Qualification

Cytovance can qualify analytical methods, to be used for in-process or release testing, according to parameters described in the ICH guidelines Validation of Analytical Procedures: Text and Methodology Q2 (R1). Qualification parameters may include:

  • Accuracy
  • Precision (repeatability, intermediate precision)
  • Specificity
  • Detection Limit (DL)
  • Quantitation Limit (QL)
  • Linearity
  • Range

Method Validation

Cytovance analytical team can validate required analytical methods using reference Standard and a testing matrix. The methods must produce results as outlined in the validation protocol to provide quantitative data indicating the method suitability for use in product manufacture.