GXP

Risk Analysis and Design of Experiments in Process Validation Stage 1 | IVT

Introduction Process design, the first stage in the FDA lifecycle approach to process validation, lays the foundation for process understanding and control. The work of stage one enables subsequent stages, Stage 2 and Stage 3, to be successful. Process design allows for the characterization and understanding of how the process responds to the various process inputs and variables. This effectively addresses one of the significant flaws in the previous process validation paradigm—the failure to account for inherent variability in process inputs (1). Stage 1 work allows for a better understanding...

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