Basic Concept of Process Validation in Solid Dosage Form (Tablet): A Review

Abstract

Process validation is an essential component for the safety of drug product and also to maintain the quality of the product. Process validation is the fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to assure the identity, purity, safety, efficacy and also maintaining the quality of final product. The Process validation precisely focused on the aim, method of analysis, and knowledge. The Process validation establishes the flexibilities and limitations which are faced during the manufacturing process; the variables are controlled for attaining the desired attributes, which assures a consistency in quality of product throughout the product life. In this article an overview is given on process validation with special reference to tablet.

Process Validation of Paracetamol Tablets: A Comprehensive Study Based on ICH Guidelines

“…The article also explores the role of regulatory guidelines, such as the ICH Q8 (R2), Q9, and Q10, in facilitating effective process validation. (1)…”