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…
Introduction
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…
Cycle Approach
Figure 3.1 Process validation life cycle. Source: Modified from G. McNally, FDA.6 Figure 3.2 Simple life cycle approach.
