KBI's Approach to Process Characterization & Process Validation
Process Validation: ”Collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
Guidance for Industry - Process Validation: General Principles and Practices, January 2011
Process Validation is a lifecycle of activities consisting of the following stages:
Stage One (1a & 1b): Process Design
Using product and process knowledge gained during development and scale-up activities to define the commercial process and control strategy.
Stage Two: Process Qualification
A formal study with the aim of confirming that the commercial process is capable of reproducibly producing product meeting pre-defined acceptance criteria at-scale.
Stage Three: Continued Process Verification
Systematic program established to ensure that the commercial process remains in a state of control.
KBI performs these late-stage process characterization and scale-down validation studies as a stand-alone package to support late-stage process development and commercialization from a client’s manufacturing plant or from KBI’s manufacturing plant. KBI also supports PAI (pre-approval inspections) and other regulatory inspections needed for product approval.
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