DIFFERENT ASPECTS INVOLVED IN PROCESS VALIDATION
Abstract
Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes. Validation of the individualsteps of the processes is called the process validation. Process validation involves the collection and evaluation of data, from the process design stage throughout production, that establish scientific evidence that a process is capable of consistently delivering a quality drug substance. It is internationally recognized that validation is necessary in analyticallaboratories. The use of validated methods is important for an analyticallaboratory to show its qualification and competency.This new approach to process validation encompasses equipmentand utility qualification and is fully science and risk-based. Itprovides the pharmaceutical industry with the opportunity tore-think the whole concept of validation and ensure that theseactivities add real value to our businesses and to patients.It involves prospective validation, retrospective validation and concurrent validation.A life-cycle approach should be applied linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.
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KEYWORDS:Validation, prospective validation, concurrent validation, retrospective validation, quality by design
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