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…
the Protocol
Figure 8.4 Flow plan for protocol execution. Samples need to be taken from the production line at intervals that will allow a sufficient statistical6 evaluation of the results. Each of…
