An Overview Of Quality By Design Engineering Essay

An Overview Of Quality By Design Engineering Essay Since there is immense competition globally and growing impact of Information technology, the pharmaceutical industry should need to improve its performance. The industry should implement newer technologies that can effectively reduce cost of production and at the same time improves product quality and regulatory compliance. Quality by Design is a newer approach that has been offered by the United States Food and Drug Administration (USFDA) which if understood well and implemented properly can save considerable amount of time and cost and at the same time can improve final product quality and regulatory compliance which can increase the speed of product to reach in to the market. This article discusses the background of quality by design concept, Building blocks of Quality by Design, and its approach across the product life span and benefits that it offers. Introduction: In 2002, the U.S. Food and Drug Administration (FDA) published a guidance document for pharmaceutical companies o n cGMP for the 21st century. This guidance document expressed a strong desire that companies should build quality, safety and efficacy in to their product. This concept is now known as Quality by Design (QbD). Till now, the meaning, benefits and impact of quality by design is confusing to many people. Some says that it is a newer way to develop drugs, biologics and devices; some says that it can shorten the production cycle; some says that it provides more business flexibility but no one knows what it is exactly. Some people do not even know that where, when and how should it be applied? Initially there are so many companies who tried to adopt Quality by Design concept but confusion gave way to frustration. Background of Quality by Design: Quality by design (QbD) is the concept first developed by the famous quality expert named Joseph M. Juran in his 1992 book called â€Å"The New Steps for Planning Quality in to Goods and Services†. He believed that quality could be planned in the very first stage of the production rather than final testing. The concept was first used in automobile industry. There is one article published in June 2007 titled â€Å"Elucidation: Lessons from the Auto Industry† says that Toyota Automobiles was the first company who implemented many Quality by Design concept to improve their automobiles in 1970s. That is why we can say that Quality by Design concept is new only for FDA regulated industries and not for other industries like technology, aeronautics, telecommunications etc. In other words, we can say that the computer we use, the phone we answer, the airplane we ride, the car we drive and the camera we use are all products of Quality by Design but we cannot say that whatever tablet we ingest and whatever biologics we use are the products of Quality by Design. In 1990s, many of the medical device manufacturing company has implemented Quality by Design aspect which resulted in reduced risk and manufacturing cost and at t he same time increased patient safety and product efficacy. From the success of QbD aspect in medical device manufacturing, the FDA officials felt that this concept has to be applied to drugs and biologics also. So, the internal discussion in FDA started in late 1990s and finally they published a concept paper in 2002 on cGMP in 21st century. With the huge help of some pharmaceutical companies, pilot programs were started to share the Quality by Design application and process understanding with the other companies.