A review on pharmaceutical process validation Ansari Samsuddin1,*, Kumar Ankit2,**, Prajapati Manju3,***, Rai Janki Prasad4,**** 1Practitioner, Bachelor of Pharmacy, School of Pharmacy, LNCT University, Bhopal, Madhya Pradesh, India 2Student, Bachelor of Pharmacy, School of Pharmacy, LNCT University, Bhopal, Madhya Pradesh, India 3Professor, School of Pharmacy, LNCT University, Bhopal, Madhya Pradesh, India 4Professor, School of Pharmacy, LNCT University, Bhopal, Madhya Pradesh, India *Corresponding Author E-mail: samsuddinansari2078@gmail.com
**singhankitkumar86@gmail.com
***manjuprajapati31@gmail.com
****Jp.monu@gmail.com
Online published on 10 April, 2025. Abstract This article provides an introduction and a brief of process validation in the pharmaceutical manufacturing process. Process validation deals with process design aspects and maintaining process control during commercialization. It also conveys that process validation is an ongoing program and aligns process validation activities with the product life cycle. When considering any product, quality is always a mandatory must-have. As a result, drugs must be produced with the greatest quality requirements. Process validation is a key stage in assessing and maintaining the quality of the final product. This article goes over the following topics: introduction, validation type, prospective validation, retrospective validation, concurrent validation, revalidation validation, process validation elements, documentation, validation master plan, validation methodology, and validation report. Process validation also emphasizes the role of objective statistics, statistical tools, and analyses, as well as understanding, identification, and control of variability, and assures consistent quality/productivity throughout the product's lifecycle. The validation research establishes and documents the accuracy, sensitivity, specificity, and repeatability of the firm's test techniques. Thus, validation is a vital component of quality assurance. In recent years, the importance of validation has grown significantly. Top Keywords Validation, Process Validation, Protocol, Validation Master Plan, Documentation. Top |