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…

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…

Figure 9.1 Decision tree for deviation classification. Source: From the World Health Organization (WHO).4

1Note: Stage III is Continued Process Verification—this allows one to add or delete CPPs and/or CQAs based on production. This will be discussed in Chapter 10, “Stage III—Collection and Evaluating…

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…

Introduction The process validation protocol is relatively easy to prepare IF all of the characterizations and work up of the process has been completed in Stage I. By the time…