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:
“One of the reasons for the failure of feminism to dislodge deeply held perceptions of male and female behaviour was its insistence that women were victims, and men powerful patriarchs, which made a travesty of ordinary people’s experience of the mutual interdependence of men and women.”
—Rosalind Coward (b. 1953)
“In looking back over the college careers of those who for various reasons have been prominent in undergraduate life ... one cannot help noticing that these men have nearly always shown from the start an interest in the lives of their fellow students. A large acquaintance means that many persons are dependent on a man and conversely that he himself is dependent on many. Success necessarily means larger responsibilities, and responsibilities mean many friends.”
—Franklin D. Roosevelt (1882–1945)