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Validation is defined as per various bodies EC, ICH, FDA, WHO as given below:
According to European Commission
1991: Validation-“Act of proving, in accordance of GMPs that Any…” process actually leads to expected results.
2000: “Documented evidence that the process, operated within established Parameters, can perform effectively and reproducibly to produce a Medicinal product meeting its redetermined specifications and quality attributes”
According to US FDA Definition
“Process validation is establishing documented evidence which provides a high degree of assurance that a specified process will consistently produce a product meeting its predetermined specifications and quality characteristics”.
According to ICH Definition
“Process validation is the means of ensuring and providing documentary evidence that processes within their specified design parameters are capable of repeatedly and reliably producing a finished product of the required quality”.
According to WHO Definition
“The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to expected result”.
Ted Byers and Bud Loftus, two FDA (Food and Drug Administration) officials, suggested the idea of validation to raise the calibre of pharmaceutical products in the middle of the 1970s. In response to an increase in problems with parental sterility products, it was proposed. When these pharmaceuticals were originally being manufactured, the procedures were the focus of validation efforts, but over time they expanded to cover all pharmaceutical manufacturing processes.
