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Parametric Release for Cleaning Part I: Process Characterization | IVT

An important regulatory expectation for cleaning is that the validated state of the cleaning process be maintained throughout the lifecycle of the product (4, 5).  This expectation may be met by performing scheduled reviews of data and documentation such as clean-and-use logs, process deviations, investigations, impromptu inspections, management reviews, and combinations thereof.  These activities, along with change control, are the key elements of a robust monitoring program.  Some organizations verify the effectiveness of their cleaning procedures periodically as part of their...

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