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:
“While there are practical and sometimes moral reasons for the decomposition of the family, it coincides neither with what most people in society say they desire nor, especially in the case of children, with their best interests.”
—Robert Neelly Bellah (20th century)
“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)