industry standard ich q2 imageThe International Conference on Harmonisation (ICH) is an expert working group with representation from the United States, European and Japanese Pharmacopoeias.

In their harmonized tripartite guideline ICH Q2, Validation of Analytical Procedures: Text and Methodology, they outline characteristics to consider during validation of the four most common types of analytical procedures:

  • Identification tests
  • Quantitative tests for impurity content
  • Limit tests for the control of impurities
  • Quantitative tests of the active moiety in samples of a drug substance/product or other selected component(s) in a drug product

ICH Q2 differentiates between validation characteristics required for analyzers used for limit testing of impurities and those used for quantitative analysis of impurities.

Typical validation characteristics include:

  • Accuracy

  • Precision

  • Repeatability

  • Intermediate precision

  • Specificity

  • Detection Limit

  • Quantitation Limit

  • Linearity

  • Range  

The final draft of ICH Q2 is recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.



In this webinar, Tony Harrison of Beckman Coulter Life Sciences discusses the validation of on-line TOC analyzers for product release testing using ICH Q2.

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