A Review on Pharmaceutical Process Validation

A Review on Pharmaceutical Process Validation

Author Name : Manali M. Bode, Shailesh G. Jawarkar, Monika P. Jadhav, Dipali S. Doifode

ABSTRACT

The concept of validation was first proposed by Food and Drug Administration (FDA) officials in order to improve the quality of Pharmaceuticals. A 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.” Validation is the art of designing and practicing the designed step alongside with the documentation. Validation and Quality assurance will go hand in hand, ensuring the thorough quality for the pharmaceutical products. The collection the data from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products known as Process Validation. Validation does improve processes but also confirms whether the process is properly developed and therefore decreases the risk of errors. The validation study provide the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality quality assurance. The purpose of this review is to present an introduction and general overview on process validation of pharmaceutical manufacturing with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).

Keywords: Validation, Process Validation, Quality Assurance, Documentation, cGMP