Method development & validation

METHOD DEVELOPMENT & VALIDATION

Curida has an extensive knowledge and expertise in developing− and validating methods for finished products including cleaning validation. We offer development and documentation of analytical methods, and analytical protocols and reports in compliance with the ICH Q2 (R1) guideline “Validation of Analytical Procedures: Text and Methodology”. Once a method is validated, it may require transfer. Method transfer may involve comparative testing, co-validation between two sites (Lab-to-Lab), complete or partial revalidation and comprehensive documentation (Transfer Plan, Protocol, Report). Whether Curida is the developing or the receiving laboratory, we can assist you with your method transfer requirements.

 

METHOD DEVELOPMENT

  • Identification
  • Assay testing
  • Testing for impurities
  • Stability indicating methods
    • Temperature
    • pH variation
    • Oxidative stress
  • Microbiological method development

VALIDATION

  • Accuracy (assay and impurities)
  • Precision
    • Repeatability
    • Intermediate precision
    • Reproducibility
  • Specificity (for identification, assay and impurities)
  • Detection limit
  • Quantitation limit
  • Linearity
  • Range
  • Robustness
  • System suitability test
  • Microbiological validation