VALIDATION: A CRITICAL PARAMETER FOR QUALITY CONTROL OF PHARMACEUTICALS

Abstract

The current objective of this review is to understand the types of validation, its basic concept and applicability in the pharmaceutical industry. Method validation is the process by which it is established that performance characteristics of the method meet the requirements for the intended analytical applications. Methods need to be validated or revalidated before their introduction into routine use. The most compelling reasons to optimize and validate pharmaceutical productions and supporting processes are quality assurance and cost reduction .the basic principles of quality assurance has as their goal and the production of articles that are fit for there intended use. These principles are Quality, safety, and effectiveness must be designed and built in to the product, quality cannot be inspected or tested in the finished products and each step of the manufacturing process must be controlled to maximize the probability that the finished product meets all quality and design specification. Through this review the authors make an effort to explain the concept of validation and provide an insight to its importance in the pharmaceutical industry. Key words: validation, process, analytical, qualification, quality control.