the Protocol
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…
Protocol Test Ranges
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…
Considerations
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.),…
Protocols—Installation Qualification (IQ) and Operational Qualification (OQ)
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…
It All Starts
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…
Parameters
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…
Cleaning Considerations
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…
Investigation
The Investigation5 Now that the type and extent of the deviation has been determined the event needs to be investigated. In both type of deviations the investigation for the real…
