How Validation Pays for Itself

Abstract

If every batch coming off a production line could consistently reproduce a drug product meeting its predetermined specifications and quality characteristics, there would be very little need for validation. Unfortunately, in the real world of manufacturing, many factors combine to make each unit unique and, therefore, a need for validation exists. In the current article, the importance of validation in the pharmaceutical industry is described along with four basis benchmarks for total validation success. Guidelines for measuring validation productivity are discussed. Validation payback from several areas is explained, keeping justification of validation activities in mind. Starting a strong validation program takes time. It has an initial cost, but the total cost of poor quality is much higher. High quality is a key indicator of product superiority. A systematic validation program improves product quality on one hand and enhances productivity on the other. Prevention such as validation is often not hard to do, it is just hard to sell.