OQ and PQ exams should really bear in mind the geometry from the sample (e.g. condition and dimensions of the container, and distance into the sensitive area in the detector). Re-qualification plan of dose calibrators should really account that day by day checks (e.g. constancy tests) tend to be done, and in addition verification of linearity and r
Details, Fiction and 3 sigma rule for limits
Control limits should not be bewildered with tolerance limits or requirements, which can be entirely impartial on the distribution with the plotted sample statistic. Control limits explain what a system is capable of manufacturing (from time to time called the “voice of the process”), when tolerances and specs explain how the product must accom