The new ICH Draft Guideline Q2 Validation of Analytical Procedures (Revision 2) - Live Online Training Mission accomplished?

The new ICH Draft Guideline Q2 Validation of Analytical Procedures (Revision 2) - Live Online Training

Course No 19438

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Dr. Joachim Ermer, Ermer Quality Consulting, Germany


After almost 2 years of delay, the draft guidelines Q2(R2) and Q14 have been published for public consultation end of March 2022. The participants will learn what aspects have changed and what is new in the revised Q2 guideline. A critical discussion will be provided whether the gaps and uncertainties are sufficiently addressed, in particular considering the new USP General Information Chapter <1220> The Analytical Procedure Lifecycle. Some of the examples provided in Annex 2 will be critically discussed and evaluated.


Since the implementation of the ICH Guideline Q2, Validation of Analytical Procedures in 1994, many topics emerged in the pharmaceutical area, in particular in manufacturing, towards a holistic lifecycle management, such as the ICH Guidelines Q8-12, or the FDA and EU process validation guidelines. Although ICH Q2 served its role to harmonise terminology and basic requirements with respect to analytical validation, some gaps and uncertainties remained and became more and more obvious in the light of the recent developments. For example, the major focus of Q2 on chromatographic methods, the lack of clarity what suitability means (acceptance criteria linked to the measurement requirements for the respective Critical Quality Attribute), or the confusion between the response function (calibration model) and linearity of the analyte in the sample (accuracy). Consequently, in November 2018, a concept paper was published describing the area of improvements for a revision of the Q2 Guideline as well as the introduction of a new, related ICH Guideline Q14 on Analytical Procedure Development. With respect to the Q2 revision, a broader range of techniques such as NIR, Raman, NMR, hyphenated techniques, lifecycle aspects with the inclusion of post-approval (ongoing) verification and maintenance, emphasis on systematic analytical development, and multivariate models were intended to be considered.

Target Group

This Live Online Training is aimed at executives and employees from Quality Control, Quality Assurance, and regulatory who want to gain an overview on the revised ICH Q2 Guideline.

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Adjustments and Additions in Q2(R2)
  • Validation protocol and acceptance criteria
  • Validation of platform analytical procedures
  • Multivariate analytical procedures
  • Performance characteristics
  • Specificity / selectivity
    • Technology inherent justification
  • Reportable / Working Range
    • Response (calibration) functions: linear, non-linear, multivariate
    • Lower limit (detection and quantitation limit, reporting threshold)
  • Accuracy
    • Inference
    • Demonstration via confidence intervals
  • Precision
    • Compatibility to specification limits
  • Combined evaluation of precision and accuracy
  • Total Analytical Error
  • Demonstration via prediction or tolerance intervals
How much Lifecycle is in Q2(R2)?
  • Validation during the lifecycle
  • Links to Q14
  • Use of data and results from development
  • (Missing the) Analytical Target Profile
Discussion of the illustrative Examples in ANNEX 2
  • Quantitative separation techniques (assay and relative area quantitation)
  • Elemental impurities by ICP-OES/MS
  • Dissolution for immediate release (quantitation with HPLC)
  • Biological assays
  • Particle size measurement

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