Changeover

The steps taken for switching multi-product equipment from manufacture of one product to another

Synonymous with "product changeover" changeover is defined in PDA Technical Report 29, Points to Consider for Cleaning Validation as "procedural steps taken for switching from the manufacturing of one product to another product". These procedural steps are risk based which include the cleaning of equipment, which often includes sampling of the cleaned surfaces to ensure carry over from one product into another is within acceptance limits. Changeover activities also includes the cleaning of the manufacturing area including the removal of labels and documents associated with producing the product which has been produced.