Besides regulatory expectations, the Webinar 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 bio-pharmaceuticals. 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.
The following topics will be covered in the webinar:
- Regulatory requirements
- Integration into the analytical lifecycle concept (draft USP information chapter )
- Benefits of monitoring analytical performance
- What are the sources of analytical performance information?
- 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
Duration of the Recording: Appr. 1,5 h
Recording from 30 July 2020