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 words reasons for and/or reasons:
“Happy the man who has been able to know the reasons for things.”
—Virgil [Publius Vergilius Maro] (70–19 B.C.)
“Here we also see: what this divinity lacks is not only a sense of shame—and there are also other reasons for conjecturing that in several respects all of the gods could learn from us humans. We humans are—more humane.”
—Friedrich Nietzsche (1844–1900)