ABSTRACT

The introduction to validation and a standard framework for process validation in the pharmaceutical business are the main topics of this essay. "Validation is documented proof that offers a high level of assurance" is the definition of the term validation. One of the recognized and significant topics in the pharmaceutical industry nowadays is validation. The method has been developed so that all of the specified requirements have been met and that regular production will always result in an output that satisfies the necessary parameters. Together, the overall quality of the products will be ensured via validation and quality assurance. Process validation guarantees that a procedure will consistently produce a product that satisfies its specified quality standards. It is a crucial step in manufacturing, prototyping, and design. As all products must adhere to the highest quality standards, it is imperative that medications are manufactured to these stringent standards as well. This article offers a comprehensive overview and highlights the importance of process validation in pharmaceutical production. Keywords: Validation, Process Validation, Documentation, Analytical Methodology
Publication date: 01/01/2026

https://ijbpas.com/pdf/2026/January/MS_IJBPAS_2026_9746.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.1.9746