Target Group
- Managers and professionals from Quality Control, Quality Assurance and Regulatory Affairs who want to deepen their understanding of GMP requirements for analytical procedure validation.
- Participants looking for practical recommendations for efficient study design, execution and evaluation of analytical Validation.
Objectives
The regulatory requirements to validation of analytical procedures utilised for release and stability studies of drug substances and drug products are described in the ICH guideline Q2(R2). However, its degree of detail is rather low, and the examples provided in Annex 2 often lack orientation beyond the guideline text. Therefore, this Live Online Training provides besides these regulatory expectations practical interpretation and recommendations for demonstration of the suitability of analytical procedures. The revision of the USP General Information Chapter <1225> “Validation of Analytical Procedures”, published November 2025 provides urgently needed interpretation of some neglected aspects in the ICH guideline Q2(R2), for example with respect to precision levels, replication strategy for the reportable result, and acceptance criteria.
The ICH Q2(R2)/Q14 Training Materials published in July 2025 is critically discussed, emphasizing some deficiencies and gaps, for example the inappropriate mixing of precision levels, or the lack of orientation how to derive appropriate acceptance criteria or to establish a suitable replication strategy.
A rational and efficient validation approach is ultimately based on the respective routine application, which should be reflected in the validation design. This includes the identification of the relevant performance parameters, the selection of appropriate tests and calculations and, in particular, the establishment of acceptance criteria for the Evaluation.
These recommendations are illustrated by practical exercises, demonstrations, and interactive polls/discussions (Mentimeter based).
Programme
- The Analytical Procedure Lifecycle – USP General Information Chapter <1220> and ICH Q14
- 3 Stages of the analytical lifecycle
- Performance characteristics (ICH Q2(R2))
- Critical Quality Attributes - measurement requirements (Analytical Target Profile)
- Empirical acceptance criteria (experience, prior knowledge, state-of-the-art)
- Requirement-based: derivation from specification limits (tolerance factors, from normal distribution probability)
- Simple and statistical evaluation
- Consideration of uncertainty according to Q2(R2) (confidence, prediction, tolerance intervals)
- Precision levels (system precision, repeatability, intermediate precision, reproducibility)
- Gaps and deficiencies in ICH Q2(R2) and Training Materials
- Design of precision studies and calculations (precision levels, confidence intervals), USP <1225> Revision
- Precision of the reportable value (small molecules, bioassay)
- Optimisation of precision by averaging (replication strategy)
- Reportable range
- ICH Q2(R2): Comparison, recovery, and technology-inherent justification, combined evaluation of accuracy and precision
- Statistical evaluation (confidence, prediction, tolerance intervals)
- Significance and equivalence tests
- UV response factors
- Acceptance criteria:
- Assumption of absence of true bias, variability and expected difference between means
- For impurities
- Adjustments in ICH Q2(R2)
- Comparison and (chromatographic) separation
- Samples for investigation of specificity
- Peak purity investigations
- From “linearity” (ICH Q2(R1)) to response functions (ICH Q2(R2))
- Reportable range and working range
- Requirements to calibration models
- linear single-point and multiple-point calibration,
- weighted linear Regression
- non-linear calibration
- Statistical calculations (regression, suitable and non-suitable parameters)
- Acceptance criteria for calibration function
- residual and sensitivity plot
- ordinate intercept
- Non-linear response functions
- Concentration dependence of precision (Horwitz-function)
- ICH Q2(R2): Quantitation limit and reporting threshold
- Capability and requirement-based quantitation limits
- Approaches to determine detection and quantitation limits and their pitfalls (blank procedures, from response (linearity), from precision)
- Consideration of practical relevance (samples, concentration range for linearity approaches)
- Monitoring of selected analytical procedure outputs to facilitate continual improvements: Prevention is better than cure
- Performance metrics: Conformity, validity, quantitative performance parameters
- Statistical Process Control (SPC) tools
Further Information
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-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.
ECA Members EUR 1,090
APIC Members EUR 1,190
Non-ECA Members EUR 1,290
EU GMP Inspectorates EUR 645
The fee is payable in advance after receipt of invoice.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The official conference language will be English.
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm, +49 (0)6221 84 44 18, grimm@concept-heidelberg.de
Date & Time
All times mentioned are CEST.
Costs
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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