ABSTRACT
Once the cleaning process is validated, it should be operated under change control procedures, and the validation should be confirmed on a regular basis [1,2]. The cleaning validation master plan should specify that validated cleaning procedures are operated under change control. There should be a change control SOP (Standard Operating Procedure) that specifies the responsibilities, procedures, and templates for documenting information related to changes. The cleaning validation master plan should also specify the frequency of "revalidation" and the requirements for revalidation.
