Validation Tutorial

Validation TutorialThis tutorial is designed to enhance knowledge of biotechnological/pharmaceutical processes. The topics covered within this tutorial will give preliminary explanations and conclusions. However, references for more in depth study will be provided. It is strongly is suggested that you investigate these references.eOverviewWhat is Validation?– This section will define validation and will put its meaning in terms pertinent for a chemical engineer.Food and Drug Administration (FDA) – This section will explain the role of the FDA in validation and the guidelines it sets forth.Equipment Validation– This section will explain what role unit operations equipment plays in validation and why that is important.Process Validation– This section will explain the implications of validation in the overall manufacturing process.Applications to Facility Design– This section will discuss considerations to facility design in light of validation.What is Validation?According to the Food and Drug Administration (FDA), the goal ofvalidation is to:“establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality [1][1]attributes.””What is Validation?What does this mean?– An quantitative approach is needed to prove quality, functionality, and performance of a pharmaceutical/biotechnological manufacturing process.– This ...