Browsing by Author "Basu, Prabir K."

In the pharmaceutical industry, systems for improving operational effectiveness and efficiency are becoming more and more popular. In this paper, developments in the industry's improvements in operational effectiveness and efficiency have been analyzed. A holistic model is presented which builds the basis for the presented study results. The study includes data gathered from pharmaceutical production sites in surveys in 2004 and 2009. The analysis is divided according to the four sub-systems: Total Productive Maintenance, Total Quality Management, Just-in-Time, and the Management System. For each sub-system, key performance indicators and associated elements (practices and instruments) from 2004 to 2009 are investigated. The data indicates that the industry did make continuous steps towards "Excellence in Operations" between 2004 and 2009. Pharmaceutical companies took control over their former low asset utilization and managed to improve the efficiency of their quality systems; however, they are still far away from having any kind of "continuous flow", smooth production scheduling or make-to-order manufacturing. It can be said that most of the companies are still working on the effectiveness side rather than focusing on the efficiency side.

In our second book on Operational Excellence in the Pharmaceutical Industry titled "The Pathway to Operational Excellence", published in 2010, we had undertaken an imaginary journey to develop the framework and structure of the book. It gave us the opportunity to describe our experiences from working with dozens of different pharmaceutical manufacturers in the US and Europe. We suggested a sequence starting with preparing for the journey and finishing with the re-definition of the destination leading to the selection of the next destination so that the journey will be an on-going one. Two years later, we have decided to write another book. The main reason for doing this is the positive feedback we have received on the first two books. The other reason is our conviction that despite the renewed enthusiasm for outsourcing in the industry, manufacturing will remain a critical activity for every major pharmaceutical company, and the continuous improvement of manufacturing will not just be an option, but a necessity.

Introduction Due to increasing cost pressures and structural changes in the pharmaceutical industry in recent years, pharmaceutical manufacturers have been forced to focus on the optimization of their production processes. Therefore, operational excellence is receiving broader attention throughout the pharmaceutical industry. However, too many of these practices are attempting to reduce the cycle time or increase the output of single-process steps rather than optimizing the overall process from a holistic perspective. Objective This paper addresses the concept of a "Takt-time" analysis for pharmaceutical manufacturing. A Takt-time diagram is a tool to identify bottlenecks in a production process. It visualizes the cycle time of a product and the times per process step and relates it to customer demand (Takt time). Thus, the bottlenecks in the production flow are revealed, and production can be reorganized. However, the application of the Takt-time analysis to pharmaceutical manufacturers shows specific challenges because of their manufacturing characteristics, such as batch processing. Methods The concept for a Takt-time analysis was developed while working on a project with a CMO of an imaging agent to address the practical challenges in implementing its concept in pharmaceutical manufacturing. Results The concept creates the basis for a process redesign at a multiproduct production site. It lays the foundation that customer demands can be matched with an aligned production process, and that a seamless production flow driven by customer demands can be realized.

This article provides a comprehensive overview of outsourcing in pharmaceutical manufacturing. It discusses the motivation of the industry to leverage outsourcing advanteages, especially to China and India, but also related disadvantages. Key facts about quality issues related to outsourcing are outlined with examples. The increasing complexity of pharmaceutical manufacturing supply chains an an aggravated oversight of suppliers with the loose of control are just one explanation for that. Furthermore, the article describes how outsourcing impacts quality risks and draws on examples from the past. To mitigate these, practical advice for supplier due diligence, contractor selection and assessment process, and how to achieve operational excellence in outsourcing and internal manufacturing is drawn from a cost and risk perspective.

The history of operational excellence (OPEX) in the pharmaceutical industry is short; the first serious OPEX initiatives were only launched about 10 years ago. Before that, the pharmaceutical industry was reluctant to put OPEX and continuous improvement on its agenda, in part because of the regulatory environment but also because it was not suffering from the same cost pressures facing other industries, such as the automotive and electronics sectors, which were forced to adopt OPEX earlier. The discussion about a more scientific approach to pharmaceutical manufacturing only really began at a US FDA scientific advisory board meeting towards the end of 2001. The agency was facing an increasing number of post-approval manufacturing amendments at the time, making it tough to fulfill their review and inspection obligations. It became apparent that the industry did not truly understand its own manufacturing processes and that there were gaps in the science needed to gain useful knowledge. Current good manufacturing practices (cGMP) were being driven more by experience than sound science, which raised concerns, as did the overly risk-averse nature of industry and regulators.

The pharmaceutical industry is definitely a high-tech industry, for its role in discovery of new medicines for the treatment of unmet medical needs. Pharmaceutical manufacturing is complex and sophisticated due to various reasons, but in its current state probably cannot be categorized as really high-tech, too. In fact, pharmaceutical manufacturing was considered as relatively low-tech even by the pharmaceutical companies themselves as recently as in 2002. When ex-FDA commissioner Mark McClellan sought a benchmark for future pharmaceutical manufacturing performance, he looked outside the industry, and challenged Pharma, "You need to improve…Other high-tech industries have achieved enormous productivity gains in manufacturing in the last 25 years. We should expect nothing less from the Pharmaceutical industry."

In order to face a new marktet reality, Operational Excellence initiatives will build the cornerstones of future operations strategies in the pharmaceutical sector. The biggest challenge is and will be the engagement of people. The authors of this book point out that it will be the ability to make each employee think in terms of continuous improvement and change that will enable companies to overcome the organizations' internal inertia and separate the winners from the losers. Leading managers, consultants and researchers from both sides of the Atlantic contributed to tis second book about a topic that has already started to change the way thousands of employees understand and do their jobs. As addition to the first book "Operational Excellence in the Pharmaceutical Industry" which focused on the essence of OPEX, this book focuses on the managerial and organizational aspects of comprehensive Operational Excellence programs.