Quality by Design (QbD) for Analytical Methods
John C. Fetzer, Ph.D., has had over 30 years of experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. For over 8 years, he supervised a GLP compliant laboratory section composed of 6 separate chromatography laboratories. He has taught courses on statistics and compliance for over a decade.
This 60-minute presentation will highlight the use of statistical tools to monitor operations for a proactive operation.
There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is then collected and plotted on a control chart. Using Nelson’s rules of statistical use of control charts, the individual uncertainties are monitored. This allows for early observation and intervention before non-compliance occurs.
By looking through a method SOP and with knowledge of the chemistry and instrumentation, certain critical factors can be found. Others may be known from past non-compliances. Each of these factors can be assessed as a way to monitor steady and acceptable performance or times in which changes occur. This is done by measurement of a specific parameter and following that over time by using a control chart. Critical warning factors based upon Nelson’s rule, which themselves are based on statistical probabilities, determine acceptable behavior or a likely deviation. These deviations then are signs that a preventive action is done before there is a non-compliance.
- Understanding uncertainty within the steps of an SOP
- Knowing how to choose critical steps that can cause a non-compliance
- Knowing how to choose a monitoring variable
- Understanding Control Charts
- Understanding Nelson’s Rules
- Being able to have a trigger for a preventive action
Who Should Attend
Any laboratory that is using GLP or ISO 17025 for compliance – any laboratory doing samples in pharmaceutical, biomedical, environmental testing, or assuring compliance with regulations.
Why Should Attend
A non-compliance, when results are outside of +/- 3 σ, is a catastrophe that must be avoided. Using knowledge of a method allows for monitoring and preventive actions that can make a non-compliance very, very rare.