Authors : Chinmayee Mishra; Rajlaxmi Patro

Volume/Issue : Volume 10 - 2025, Issue 2 - February

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DOI : https://doi.org/10.38124/ijisrt/25feb1548

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Abstract : Process-validation(pv) is a critical component in ensuring the quality, safety, and efficacy of products in industries such as pharmaceuticals, biotechnology, and food manufacturing. This review provides an overview of the principles and basic concepts involved in process validation. The main emphasis is on comprehending the function of validation in quality assurance and regulatory compliance, as well as the techniques used to show that a process reliably yields a product that satisfies predetermined standards. In addition to highlighting important regulatory criteria like those from the FDA and ICH, the review looks at the three steps of process validation: process design, process certification, and continuing process verification. It also explores the evolving trends in process validation, including the shift towards continuous and real-time validation methods, and the application of risk-based approaches to enhance the efficiency and reliability of the validation process. This review emphasizes the importance of risk management, data integrity, and robust documentation to provide a comprehensive understanding of process validation and its significance in maintaining product quality and regulatory compliance.

Keywords : Validation, Process Validation, ICH, FDA.

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