After the creation of an SOP on Out-of-Specification results, ECA Working Group on Analytical Quality Control's next objective is the elaboration of an SOP on methods for statistical process control with regard to the statistical evaluation of the variability of production processes. The analysis of trends in stability studies will also be part of this SOP. Moreover, the handling of Out-of-Expectation (OOE) results will be addressed in this SOP, too.
Among other things, the following methods and working examples will be considered:
1. Investigation of trends for statistical process control:
Statistical process control for continuous data:
a. Shewhart Charts
b. CuSum & Zone Charts
c. Post Mortem CuSum Analysis
2. Statistical process controls for discrete data: p and c Charts
3. Trend analysis for stability testing:
a. Simplified procedure
b. More complex procedure using the "Random Coefficients" approach.
All delegates of the OOT Forum on 22 - 23 October 2014 in Prague, Czech Republic, will receive the outline of the draft version of ECA Working Group on Analytical Quality Control's SOP on OOE and OOT Results. The outputs from the workshops at the OOT Forum will provide the scope for the content of the draft guidance. The participants will receive the draft guidance after the team has put it together sometime after the Forum as defined as the next steps for this project.