Risk-Based Test Method Development, Validation and Life Cycle

摘要

The pharmaceutical industry is experiencing a growing need to improve performance driven by global competition and the increasing impact of information technology. Central to this need are good data, a characteristic of good science. Quality data are arguably more important today than ever before. It is becoming widely accepted that data are a corporate asset. The industry is also focusing on risk assessment and reduction as evidenced by FDA's focus on data integrity. Methods and tools widely used in test method development are discussed with emphasis on how these tools reduce risk in method development, validation and use. Methods discussed include experimentation strategy, method repeatability and reproducibility, method robustness and test method performance verification. Methods for assessing the amount of product variation that can be attributed to the manufacturing process, sampling procedures and test method are also presented. A system for effectively using management review to increase the sustainability of the risk-based approaches is presented. Pharmaceutical and biotech case studies and examples are used to illustrate the test method risk-reduction methods presented.