GLOSSARY: Validation Protocol (from ICH API)

Validation Protocol (from ICH API) is defined as a written plan describing the process to be validated, including production equipment and how validation will be conducted. A Validation Protocol is necessary to define the specific items and activities that will constitute a cleaning validation study. It is advisable for companies to have drawn up a Master Validation plan indicating the overall Cleaning Validation strategy for the product range / equipment type / entire site.