Method Qualification and Validation

Method Qualification and Validation at CMIC Chicago Laboratory

Method Qualification

Bioanalytical method qualification ensures a method is fit for its intended purpose, generating reliable data for non-regulated or exploratory sample analysis. This process focuses on understanding the capabilities and limitations of the method.

Key aspects include:

  • Understand Method Performance: Evaluates sample preparation, analyte detection, and quantification techniques.
  • Calibration Curve Range: Establishes a quantification range to ensure accurate measurements.
  • Define Acceptance Criteria: Sets criteria based on the intended use and regulatory requirements.
  • Analyte Stability: Examines the stability of analytes in sample matrices during storage, preparation, and analysis to prevent data degradation.
  • Selectivity and Specificity: Ensures the method targets the analyte without interference from other sample components.
  • Reproducibility: Confirms the method consistently generates reliable results under various conditions.

These aspects ensure the method’s efficiency and reliability, providing a strong foundation for subsequent analyses.

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Method Validation

Bioanalytical method validation is a rigorous process in pharmaceutical and biomedical research, ensuring the reliability, accuracy, and reproducibility of analytical methods used to quantify drugs, metabolites, biomarkers, and other analytes in biological matrices. Conducted according to FDA ICH M10 guidance, this process ensures compliance with industry standards and regulatory requirements.

Key aspects include:

  • Selectivity and Specificity: Ensures the method measures the target analyte without interference.
  • Matrix Effects: Identifies and mitigates matrix effects through sample preparation or analytical techniques.
  • Accuracy and Precision: Measures how close the results are to true values and evaluates the consistency of repeated measurements.
  • Linearity and Range: Confirms the method produces results proportional to the analyte concentration within a specified range and defines the concentration range for accurate results.
  • Lower Limit of Quantification (LLOQ): Determines the lowest concentration accurately measurable.
  • Robustness: Tests the method’s reliability under varying experimental conditions, including different analysts, instruments, reagents, or environmental factors.
  • Chromatographic System Suitability Testing: Evaluates parameters like carryover, resolution, retention time, and peak symmetry.
  • Stability and Reproducibility: Assesses the stability of the analyte and confirms the method consistently generates reliable results across different conditions.

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