Abstract

VALIDATION OF CRITICAL PROCESS PARAMETERS IN TABLET PRODUCTION

*Alok Krishan Ojha, Dr. Anju Goyal

ABSTRACT

To survive in competitive market and to be successful, it is necessary to achieve high level of product quality Validation is one of the important steps in achieving and maintaining the quality of the final product batch after batch. Without equipment, we cannot manufacture a product. By validating each step of production process we can assure that the final product is of best quality. This review provides information on objectives and benefits of process validation, types of process validation, major phases in validation and regulatory aspects. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. Process validation is an essential component for the safety of drug product and also to maintain the quality of the product. Validation is establishing documented evidence which provides a high degree of assurance that a specific process for manufacturing of tablets will consistently produce a product meeting its pre-determined specifications and quality attributes. Validation and quality assurance will go hand in hand, ensuring the quality for the products. The present article gives an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. Tablet dosage forms remain the most widely manufactured solid oral pharmaceutical products. To ensure consistent product quality, safety, and therapeutic performance, validation of the manufacturing process is essential. Critical Process Parameters (CPPs) are process variables that significantly influence Critical Quality Attributes (CQAs) and therefore must be carefully monitored and controlled. This review discusses CPP identification, validation strategies, regulatory expectations, and lifecycle process validation approaches in tablet manufacturing. A risk-based Quality by Design (QbD) framework is emphasized for developing robust and reproducible processes.

Keywords: Validation, Equipments, Tablets. Tablet Manufacturing, Critical Process Parameters, Process Validation, QbD, CQAs, Pharmaceutical Quality.