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Method Development Optimization and Validation

The expert personnel at SGS laboratories have extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning, and bioanalytical testing.

We offer development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes. This is conducted in compliance with the Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology and Validation of Analytical Procedures, Methodology by the ICH (Q2A, Q2B) and FDA guidelines.

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 SGS’s Life Science Services is the developing or the receiving laboratory, we can assist you with your method transfer requirements.

Our Method Development and Validation Services include:

  • Bioanalytical assays
  • Identification
  • Assay testing
  • Testing for impurities
  • Stability indicating methods
    • Humidity/temperature
    • pH values
    • Oxidative and reductive stress
    • Light stressing
    • Microbial testing

    Method Validation

    • Accuracy
    • Precision
      • Repeatability
      • Intermediate precision
      • Reproducibility
      • Specificity
      • Detection limit
      • Quantitation limit
      • Linearity
      • Range
      • Robustness
      • System suitability test

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