Process Validation of Polmacoxib Capsule

Abstract

Process validation ensures consistency, quality, and compliance of the end product . This project is about process validation of capsule manufacturing, with an emphasis on optimizing and standardizing the production process to meet regulatory and quality requirements. The study includes the design, qualification, and validation of key manufacturing steps such as blending, granulation, encapsulation, and packaging. Critical parameters, such as uniformity of blend, weight variation, dissolution rate, and stability, are evaluated to establish reproducibility. The objective of this study is to optimize the manufacturing process of Polmacoxib while ensuring adherence to stringent quality assurance (QA) standards. This research explores critical process parameters (CPPs) and their impact on the critical quality attributes (CQAs) of Polmacoxib during its synthesis and formulation The results demonstrate that an optimized process ensures high yield, minimal impurities, and compliance with regulatory standards. The findings contribute to enhancing the scalability and reproducibility of Polmacoxib production, aligning with Good Manufacturing Practices (cGMP).