Reasons For Validation
Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification
Read more about this topic: Validation (drug Manufacture)
Famous quotes containing the word reasons:
“She has problems with separation; he has trouble with unity—problems that make themselves felt in our relationships with our children just as they do in our relations with each other. She pulls for connection; he pushes for separateness. She tends to feel shut out; he tends to feel overwhelmed and intruded upon. It’s one of the reasons why she turns so eagerly to children—especially when they’re very young.”
—Lillian Breslow Rubin (20th century)