Validated cleaning processes changes control

Approaches to Process Validation Process Validation Program Periodic Review of Validated Systems Cleaning Validation Validation of Analytical methods Change Control, Rejection, and Reuse of Materials Rejection Reprocessing Reworking... 

Once a cleaning process has been appropriately validated, steps should be taken to help insure that the cleaning process remains consistent and in control. Steps that are taken to help assure this include regular monitoring, a change control system, training, and revalidation. 

Utility systems such as water for injection (WFl). clean steam, clean-in-placc (CIP) solutions and sterile process air must be similarly proven. Also the building system itself has to be validated. Many bioprocess operations which contain potentially hazardous materials are operated in closely-controlled negative pressure enclosures with filtration of exhaust ventilating air. Sterile and particularly parenteral products arc processed in clean rooms which are maintained at positive pressure with filtered incoming air. Validation of building control systems and of personnel changing facilities and systems of work are necessary to meet CMP requirements. Manuals for formal test procedures are required to validate these activities. 

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