Dr Joachim Ermer, Ermer Quality Consulting, Germany
Besides regulatory expectations, this Live Online Training provides practical recommendations and orientation for demonstration of the on-going suitability of analytical procedures. 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 investigate and evaluate suspect or out-of specification (OOS) results as well as for a continuous process Validation.
According to the FDA-Guidance „Analytical Procedures and Methods Validation for Drugs and Biologics“, 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 draft of the new USP information chapter <1220>. The on-going performance verification is also intended to be included in the revision of the ICH validation guideline Q2.
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.
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Regulatory Requirements and the Lifecycle Concept of Analytical Procedures
- FDA validation guidance (monitoring and trending)
- Draft USP information chapter <1220>
- Stage 1: Procedure Design and Development
- Stage 2: Procedure Performance Qualification
- Stage 3: Ongoing Procedure Performance Verification
- ICH Q2-Revision and Q14 Analytical development (concept paper)
Sources of data and information on analytical performance
Evaluation of Procedure Performance
- Indicators of performance (conformity, validity, analytical control parameters)
- Risk-based identification of suitable performance parameters (SST, from sample analysis, control samples)
- Evaluation of information and data (OOS, invalid results, control charts, average parameters)
- Continual improvements
Monitoring and Trend Analysis
- Control charts (Shewart, range, standard deviation, combined, CUSUM)
- Pragmatic establishment of rules and limits (statistical, empirical)
- Trend analysis for stability results