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Validation method :, Intermediate Precision - Coggle Diagram

- - - - percent recovery of known amount
      - assesment of accuracy
  - - - Repeatability
        
        Express the precision under same operating over a short interval of time : Intra-assay precision
        
        Assesed using min 9 determinations
        
        Min 6 determinations at 100% level
      - Reproducibility
        
        Ability reproduce data within the predefined precision
        
        Determination: SD, RSD and CI
  - - - impurities
      - degradation products
      - matrix components
    - - compare test result of the sample to a sec well characterized procedure
      - ICH documents
        
        Chromatographic procedures are udes
        
        demonstrate the degree of selectivity & peaks appropriately labeled
  - - - not necessarily quantitated
        
        under stated experimental conditions
    - - Non intrumental procedures
        
        analysis of sample with known concentration of analyte
        
        establishing min level which analyte can be reliably detected
      - Instrumental procedures
        
        exhibit background noise
        
        known low concentration of analyte with those of black samples
  - - - Can be determined woth acceptable precision & accuracy under the stated experimental conditions
    - - impurities in bulk drug substances & degradation products in finished pharmaceuticals
    - - Non instrumental procedures
        
        Analysis of samples with known concenration of analyte
      - Instrumental procedures
        
        The ICH documents describe a common approach
        
        To compare measured signals from samples with known low concentrations of analyte with those of blank samples
  - - - Linear Regression (y = mx + c)
      - Correlation Coefficient, y intercept (b), slope(m)
  - - - Demonstrated to be determined with a suitable level of precision, accuracy and linearity using the procedure as written
    - - 80 to 120 % of test Concentration
    - - 70 to 130 % of test Concentration
    - - +/- 20% over entire Specification Range
    - - From Reporting Level to 120% of Impurity Specification
      - From Reporting Level to 120% of Assay Specification