GMP: Control charts and trend analysis
In analytical chemistry and GMP environment the control charts or statistical process control charts are used to monitor the performance of the analytical methods over the time, answering the question whether or not the method still yields the same result for some reference sample/standard. "The same" is seen as having the same mean value with the same precision, which means a bias free method which is still sufficiently precise.
A recognized guide to the use and understanding of the control chart approach to the methods for statistical control is the ISO 8258.
Based on the data available, the control chart can be for:
- Individual Measurements - Characteristics Determined
- Individual Measurements - Characteristics not Determined
- Repeated Measurements - Characteristics Determined
- Repeated Measurements - Characteristics not Determined
The + and - limits at 1, 2 and 3 s (standard deviation) level are constructed in the control chart to monitor the method performance and trends.
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