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:
“I should like to know what is the proper function of women, if it is not to make reasons for husbands to stay at home, and still stronger reasons for bachelors to go out.”
—George Eliot [Mary Ann (or Marian)
“Could truth perhaps be a woman who has reasons for not permitting her reasons to be seen? Could her name perhaps be—to speak Greek—Baubo?... Oh, those Greeks! They understood how to live: to do that it is necessary to stop bravely at the surface, the fold, the skin, to adore the appearance, to believe in forms, in tones, in words, in the whole Olympus of appearance! Those Greeks were superficial—out of profundity!”
—Friedrich Nietzsche (1844–1900)