A major issue which has generated considerable discussion is the validation of cleaning procedures.  Agency documents, including the Inspection Guide for Bulk Drug Substances and the Biotechnology Inspection Guide, have briefly addressed this issue.  These Agency documents clearly point out that it is expected that cleaning processes be validated.  This inspection guide will discuss what has and has not been found to be acceptable.  It should be recognized that for cleaning validation, as with validation of other processes, there may not be a single right way.

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