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

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

Course No 21406

All times mentioned are CET.


ECA-Member*: EUR 590,--
Regular Fee*: EUR 690,--
EU/GMP Inspectorates*: EUR 590,--
APIC Member Discount*: EUR 640,--

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Dr Joachim Ermer, Ermer Quality Consulting, Germany


During the ICH Assembly Meeting on 31 October and 01 November 2023, the final ICH guidelines Q2(R2) and Q14 were adopted, after more than 3000 comments have been received each concerning the draft guidelines published in March 2022.

During this Live Online Training, 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 of the old guideline from 1994 are sufficiently addressed, in particular considering the new USP General Information Chapter <1220> Analytical Procedure Life Cycle. 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.

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, in order to prepare for future expectations.

Technical Requirements

We use Webex for our live online training courses and webinars. At information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.


Adjustments, Changes, and new Requirements 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
    - Acceptance criteria taking the uncertainty into account (e.g. confidence intervals)
  • Precision
    - Precision Levels
    - Acceptance criteria taking the uncertainty into account (e.g. confidence intervals)
  • Combined evaluation of precision and accuracy
    - 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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