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:
“It’s an old trick now, God knows, but it works every time. At the very moment women start to expand their place in the world, scientific studies deliver compelling reasons for them to stay home.”
—Mary Kay Blakely (20th century)
“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)