Dr Joachim Ermer, Ermer Quality Consulting, Germany
Regulatory guidelines discuss expectations for an ongoing control and evaluation of the suitability of analytical procedures, but – fortunately – do not provide details how to do this. Thus, the practical implementation is up to QC and QA. 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 importance of such a monitoring to identify potential failures and adverse trends as well as ensure an efficient management of changes is also discussed in the draft of the new ICH guideline Q14 “Analytical procedure development”.
This Live Online 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 an ongoing analytical performance verification.
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Regulatory Requirements and the Lifecycle Concept of Analytical Procedures
- FDA validation guidance (monitoring and trending)
- USP General information chapter <1220> (valid May 1st, 2022)
- Stage 1: Procedure Design and Development
- Stage 2: Procedure Performance Qualification
- Stage 3: Ongoing Procedure Performance Verification
- ICH Q2-Revision and Q14 Analytical development
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