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:
“Write to the point: say immediately what you want to say most, even if it doesn’t “come first.” There are three reasons for doing this. First, you will then have said it, even if nothing else gets said. Second, your readers will then have read it, even if they read no more. Third, having said it, you are likely to have to say something more, because you will have to explain and justify what you chose to say.”
—Bill Stott (b. 1940)
“Science is the knowledge of many, orderly and methodically
digested and arranged, so as to become attainable by one. The
knowledge of reasons and their conclusions constitutes abstract, that of causes and their effects, and of the laws of nature, natural science.”
—John Frederick William Herschel (1792–1871)