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생명과학 eQMS 20개 항목

Analytical Method Validation Checklist (ICH Q2)

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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. *

Analytical Method Validation Checklist (ICH Q2) 체크리스트 전체 다운로드

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