Dr Joachim Ermer
Ermer Quality Consulting
Referent:innen
All times mentioned are CEST.
Zielsetzung
Besides regulatory and compendial expectations, as discussed in the just published draft of a new USP General Information Chapter <1221> “Ongoing Procedure Performance Verification” this Live Online Training provides practical recommendations and orientation for demonstration of the continual suitability of analytical procedures across the analytical procedure lifecycle. In particular, efficient approaches will be presented to extract information and data from routine analysis. This will be illustrated with examples from quality control of chemical drug substances and biopharmaceuticals.
A comprehensive understanding of the real analytical performance is extremely helpful to identify, investigate and evaluate suspect (out-of-trend, OOT) or out-of specification (OOS) results as well as for a continuous process validation.
Hintergrund
According to the FDA-Guidance “Analytical Procedures and Methods Validation for Drugs and Biologics“ (2015), it should be continually assured that an analytical procedure remains fit for its intended purpose throughout its application. This includes an ongoing program for routine monitoring of analytical performance data, and the systematic evaluation of changes with the objective to evaluate regularly the need for optimization and revalidation, if needed. These activities belong to stage 3 of the analytical lifecycle management as discussed in the USP General Information Chapter <1220>. The ongoing performance verification is also discussed in the ICH Guideline Q14 “Analytical Procedure Development” (2023), and in the just published ICH Training Materials (Module 4 and 5).
Zielgruppe
This training is aimed at executives and employees from Quality Control, Quality Assurance, and production who want to gain a better understanding of the GMP requirements as well as current discussions with respect to the lifecycle management of analytical procedures and are interested in practical recommendations for an efficient design, execution, and evaluation of a continuous analytical performance verification.
Date & Technical Requirements
Date of the Live Online Training
Monday, 29 September 2025, 14.00 h - 17.00 h CEST
Technical Requirements
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.
Programm
Gesamtes Programm als PDF herunterladen
Regulatory Requirements and the Lifecycle Concept of Analytical Procedures
- FDA validation guidance (2015)
- USP General information chapter <1220>
- Stage 1: Procedure Design and Development
- Stage 2: Procedure Performance Qualification
- Stage 3: Ongoing Procedure Performance Verification - ICH Q14 “Analytical procedure development”
- Draft USP General Information Chapter <1221> “Ongoing Procedure Performance Verification”
Workshop
Sources of data and information on analytical Performance
Sources of data and information on analytical Performance
Evaluation of Procedure Performance
- Risk management: Factors related to analytical procedure criticality & risk-based performance monitoring plans
- Analytical Procedure Performance Metrics (conformity, validity, analytical control parameters)
- Risk-based identification of suitable performance parameters (SST, from sample analysis, control samples)
- Links to Analytical Procedure Control Strategy (ICH Q14, Training Module 4)
- Continued verification of ATP requirements and periodic analytical performance assessment
- Continual improvements
Monitoring and Trend Analysis
- Control charts (Shewhart, range, standard deviation, CUSUM)
- Statistical out-of-control rules
- Pragmatic establishment of trending rules and limits (statistical, empirical)
- Examples
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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