Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict situation of a non-compliance event.

Setting up intermediate monitoring of key stages in the methodology can observe deviations from the desired behavior before non-compliance occurs. How to choose these is individual to each methodology, but a strategy will be given to help choose ones that are useful.

Areas Covered

How to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments. There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.

Course Level - Intermediate

Who Should Attend

Chemists and laboratory assistants who perform analyses under GLP or ISO 17025.

Topic Background