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Life-Sciences eQMS 20 items

Analytical Method Validation Checklist (ICH Q2)

Confirms that an analytical procedure has been validated for its intended use with appropriate performance characteristics. Use when validating identification, assay, impurity, and dissolution methods.

ICH Q2(R2)USP <1225>21 CFR 211.194

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Method Scope and Protocol

  • Is the analytical procedure documented with its intended purpose (ID, assay, impurities, dissolution)? *
  • Is an approved validation protocol with pre-defined acceptance criteria in place before execution? *
  • Are the validation characteristics selected appropriate to the method type? *
  • Are reference standards qualified and traceable? *

Specificity and Accuracy

  • Is specificity demonstrated to distinguish the analyte from impurities, degradants, and matrix? *
  • Is accuracy assessed across the range (typically recovery of spiked samples)? *
  • Do recovery results meet the acceptance criteria? *
  • Is a forced degradation/stability-indicating study performed where required? *

Precision

  • Is repeatability (intra-assay precision) evaluated with sufficient replicates? *
  • Is intermediate precision assessed across analysts, days, and equipment? *
  • Record the reported %RSD for repeatability.
  • Is reproducibility addressed if the method is used across sites?

Linearity, Range, and Detection Limits

  • Is linearity demonstrated with an acceptable correlation coefficient across the range? *
  • Is the validated range appropriate to the specification and application? *
  • Are detection limit (LOD) and quantitation limit (LOQ) established for impurity methods? *
  • Is robustness evaluated for deliberate small variations in method parameters? *

Reporting and Approval

  • Are all raw data, calculations, and chromatograms retained and reviewable? *
  • Does the validation report conclude the method is suitable for its intended use? *
  • Is system suitability defined for routine use of the method? *
  • Quality unit approval of the validation report. *

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