Concepts of Process Validation in Solid Dosage Form [Tablet] – An Overview

Drugs having an important role in curing the various diseases in health care. Therefore, drugs must be manufactured to achieve a predictable therapeutic response with highest quality levels. End product testing by itself doesn't guarantee the quality of the product. A properly designed system will provide a high degree of assurance that every step, process and change has been properly evaluated before its implementation. Validation is the most common word in the drug development, manufacturing and specification of finished product. Process validation is a basic factor for drug product safety and quality and thus a fundamental component of the quality assurance system used by pharmaceutical manufacturers. Process validation is the key element to assure the identity, strength, purity, safety, efficacy and maintaining the quality of final product. Process validation emphasizes the role of objective measures, statistical tools and analyses, highlights knowledge, detection, establishes the flexibility, constraints in the manufacturing process, control of variability in the attainment of desirable attributes and gives assurance on consistent of quality and productivity throughout life cycle of product by preventing undesirable properties. The present article gives an introduction about validation, overview about process validation and its importance in the manufacturing of solid dosage form.