Author: Ana-Maria Glod-Lendvai

Abstract: The process validation was developed in the 20th century in order to improve the quality of pharmaceutical products. The validation concept has expanded over the last 50
years from analytical methods used to control pharmaceutical substances to analyses of computerized systems. Validation is nowadays successfully used in most areas. The validation of a method aims to ensure the effectiveness of the method from the point of view of some statistical parameters during each stage of production and not only at the end of the process. By validation, scientific evidence is established that a process is capable of consistently delivering quality products. It is also recognized internationally that validation of a product is required in any production process of a new product.

Keywords: : validation, prospective validation, retrospective validation, simultaneous validation, correlation study.

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