Abstract :
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.
Keyword :
Prasugrel Hydrochloride, Process validation, Product recalls, Quality products.