Introduction

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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…

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Cycle Approach

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

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Notes

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*Bold text in this chapter is by the author for clarity only. 1Medicinal chemistry is that group that selects or synthesizes the chemical to be screened by the research group….

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Steps

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Next Steps Once the Equipment and Utility Qualificationprocess has been planned. R&D has determined the parameters, and scale up is in the process of being implemented, there are still items…

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