The U.S. Food and Drug Administration (FDA) has strict regulations about cleaning validation.
For example, FDA requires firms to have written general procedures on how cleaning processes will be validated.
Also, 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.
Acceptance criteria for cleaning validation protocols considers limits for chemicals and actives, limits for bio burden, visually cleanliness of surfaces, and the demonstration of consistency when executing the cleaning procedure.
Regarding the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated.