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February 15, 2007 (Vol. 27, No. 4)

Regulation Shifts from Product to Process

Applying DOE and Risk-Assessment Methods Early Eases Process Validation

  • However innovative or compelling a novel manufacturing process may be, its value depends on the ability to validate the process and demonstrate its robustness and reproducibility over time. Process validation—both the concept and its implementation—is in the midst of undergoing a sea change that is at the same time ...

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