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Bruce Davis (Chairman of ISPE’s International Board of Directors)

 

Figure 2: PQLI Criticality Decision Tree to Delineate Categories and Levels of Criticality Across the Product Lifecycle (NOR = Normal Operating Range PAR = Proven Acceptable Range CpK = Measure of process robustness PAT = Process Analytical Technology)
Figure 2: PQLI Criticality Decision Tree to Delineate Categories and Levels of Criticality Across the Product Lifecycle (NOR = Normal Operating Range PAR = Proven Acceptable Range CpK = Measure of process robustness PAT = Process Analytical Technology)
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Product Quality Lifecycle Implementation (PQLI) – providing practical solutions

23 January 2008 | By

This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…