ABSTRACT
Validation of cleaning procedures has generated considerable discussion since US Food and Drug Aministration (FDA) documents, including the Inspection Guide for Bulk Pharmaceutical Chemicals and Biotechnology Inspection Guide, have briefly addressed this issue. These FDA documents clearly establish the expectation that cleaning procedures must be validated. It is recognized that for cleaning validation, as with validation of other processes, more than one way might exist to validate a process. The FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. The FDA expects a final validation report that is approved by management and states whether or not the cleaning process is valid. The data should support a conclusion that residues have been reduced to an “acceptable level.”.
