The first thing to understand before embarking on the process of creating and following up on a validation master plan, is to understand what it is. Simply put, it is a plan that shows the process of qualifying a facility, outlining the areas that require validating and ultimately, outlining the process of maintaining a facility, once it has been validated. This process is absolutely key in the pharmaceutical industry as there are certain standards to be met, as set up by the government. The process itself may be tedious and long, but worth it in the end.
During audits of your pharmaceutical company, the Food and Drugs Authority (FDA) will look through your validation documents.