Dr. Joachim Ermer
Ermer Quality Consulting
Referent:innen
All times mentioned are CET. All Information on Part 2 "Specificity/Selectivity, Response (Calibration Model), Impurities and Quantitation Limit" can be found here.
Zielsetzung
Besides regulatory expectations, in particular the new ones in Q2(R2), this Live Online Training provides practical recommendations and orientation for demonstration of the on-going suitability of analytical procedures. 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.
Both trainings focus on the relevant performance characteristics, taking the - long-awaited - revision of the ICH Q2 guideline as well as the new Q14 guideline Analytical Procedure Development from November 2023 into consideration. Lifecycle aspects will be included in the discussion.
Both trainings focus on the relevant performance characteristics, taking the - long-awaited - revision of the ICH Q2 guideline as well as the new Q14 guideline Analytical Procedure Development from November 2023 into consideration. Lifecycle aspects will be included in the discussion.
Hintergrund
According to EU GMP Guide Part 1, Chapter 6, Quality Control (6.15) and US 21 CFR 211.194, analytical procedures must be suitable for their intended purpose. 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. The lifecycle aspect of validation is treated in Q2(R2) rather as the “poor stepchild”, but covered better in the new ICH Guideline Q14 Analytical Procedure Development, and – in a true holistic way - in the USP General Information Chapter <1220> The Analytical Procedure Lifecycle.
Zielgruppe
These Live Online Training Courses are aimed at executives and employees from Quality Control, Quality Assurance, and regulatory who want to gain a better understanding of the GMP requirements for validation of analytical procedures, in particular the new aspects and requirements of the revised ICH guideline Q2(R2), and who are interested in practical recommendations for an efficient design, execution, and evaluation of a successful analytical validation.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical- 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.
Programm
Gesamtes Programm als PDF herunterladen
Lifecycle Concept, ICH Q2 Revision and Q14
- The Analytical Procedure Lifecycle – USP General Information Chapter <1220> and ICH Q14
- Overview on important adjustments and complementations in ICH Q2(R2)
- Reportable range
Analytical Target Profile
- Requirements to the analytical Performance
- Error types
- ATP in Q2(R2) and Q14
- Evaluation of performance parameters (simple, statistical)
- Aspects of an efficient validation
Precision
- Precision levels (system precision, repeatability, intermediate precision, reproducibility)
- Precision in ICH Q2(R2)
- Acceptance limits for assay
- Derivation from probability, measurement uncertainty, tolerance factors
- Design of precision studies and calculations
- Uncertainty of precisions: point estimators and confidence intervals - Optimisation of precision by averaging (replication strategy)
- Precision of the reportable value (small molecules,bioassay)
- Assay for small molecules, bioassay
Accuracy
- ICH Q2(R2): Comparison, recovery, and technologyinherent justification, combined evaluation of accuracy and precision
- Statistical significance and equivalence Tests
- Variability and expected difference between means
- Acceptance criteria for assay
Workshop: Multiple Choice Questions (from Publications)
- How to avoid mistakes in validation
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