Figure 10.2 Normal distribution. Source: PDA TR-59.5 Table 10.1 Significance of Cp Figure 10.3 Using a histogram of a CQA to produce a normal distribution curve. Source: www.moorestream.com.7 Cp=Process Capability….
Figure 7.2 ICH Q9 approach. Source: ICH Q9.7 The risk referred to, in this case, is the risk to the patient. But this risk may come from many places. There…
Table 8.2 Process Model Tests in the PPQ are based on the production batch record. Normally the product will be made according to the batch record (at target), however, during…
Testing In general, software qualification, as discussed below, requires vigorous testing along with its associated hardware. This testing needs to include the actual operation of the field instruments (valves, etc.),…
Figure 8.1 Understanding set point development. Figure 8.2 Graphical approach to set point relationships. Notice in Fig. 8.1 the Normal Operation Range falls within the Proven Acceptable Range that falls…
Table 5.2 OQ—Operating Parameters/Function Tests One function of these protocols is to document the original installation conditions; and a second important function is to demonstrate that the equipment is suitable…
Figure 4.1 Organization chart for a process validation project. Others may be involved for parts of the planning, for example, Health & Safety, Document Control, IT, etc., since almost every…
Figure 7.5 Decision tree for designating parameter criticality. Source: PDA TR60. Note the definition in (2) above. This is what is referred to as a critical process parameter. If the…
Other Cleaning Considerations As with process validation, cleaning validation needs samples in order to prove that the cleaning was and remains effective. The determination of the effectiveness, as stated, should…
