Process validation is an essential part for the safety and quality of the drug products. Validation act as guidance that is intended to assist manufacturers in understanding quality management system requirements concerning process validation. It is a fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to ensure the identity, purity, safety, and efficacy of drug products. The process validation of Prasugrel Hydrochloride Tablet USP precisely focused on the aim and method of analysis. The emphasis will be on the practical inspectional requirement, rather than on a theoretical approach that does not reflect the practicalities encountered when validating actual production operations. The Process validation reduces product recalls and troubleshooting assignments which results in more economical manufacturing process and quality products. In this paper an overview is given on process validation with special reference to solid dosage form of Prasugrel Hydrochloride Tablet USP containing dose of 10 mg.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.