PHARMACY

of Changes

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Abstract

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The Process Validation Protocol—PPQ

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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.

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….

Process Limits

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Figure 7.6 Setting parameters.

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…