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Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.
Achieving operational excellence is a challenge for the pharmaceutical industry, with many companies setting successful examples time and again. This book presents such leading practices for managing operational excellence throughout the pharmaceutical industry. Based on the St.Gallen OPEX Model the authors describe the current status of OPEX and the future challenges that have to be dealt with. The ample theoretical background is complemented hand-in-hand by case studies contributed by authors from leading pharmaceutical companies.​
The ability to find and remove barriers between people and their systems in R&D can almost guarantee a doubling in performance, and often delivers multiples of that. R&D teams that have smooth handoffs deliver 100 percent of the required knowledge at those handoffs. As a result, such teams do not lose critical information, have unexpected k
Due to the origin of Lean, it is widely used in manufacturing focussed companies like automotive industry but in current scenario the concept of Lean Manufacturing has been adopted by different businesses as well. In view of this, the objective of the report is to study the different approaches of Lean Manufacturing and the challenges which Pharma companies are facing in implementation of Lean Manufacturing and also the progress report of some companies to know whether any drug manufacture has truly made some progress or not.
Today most of the pharmaceutical companies particularly the small molecule domain, faces unprecedented challenges of escalating costs, delivering the quality products and innovations within the short term period with increasing competitive pressure from other companies. In other industries, process improvement approaches such as Lean, Six Sigma etc., have delivered the benefits in speed, quality and cost of delivery. In this paper, specific attention is given to the three key points from management point of view is that Very high productivity, Very short lead times and Exceptional product quality for any drug product. Currently, pharmaceutical industry has been slow to adopt the lean manufacturing unlike many sectors where it has been successfully deployed. In fact, Lean and cGMP go hand in hand as quality is sustained at a higher level with lower costs due to lean principles that are applied. This research study attempts to sketch out the scope and implementation ways to implement lean management principles existing in the pharmaceutical manufacturing and thereby improve the quality of products and services. This study adds to the literature by providing background information regarding the current status of lean involvement in quality system in the pharmaceutical manufacturing sectors.
Lean manufacturing focuses on speed, while traditional Six Sigma focuses on quality. Striking a perfect balance between these two business paradigms, Lean Six Sigma in the Pharmaceutical Industry introduces key lean six sigma principles to help readers improve the quality and efficiency of medical products and the predictability of supply chains. Rich with forms and charts, the book pharma companies and biotech industry professionals with an indispensable tool for implement a lean six sigma program internally rather than hiring an outside consulting firm.
With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. - A focus on the issues associated with the application of lean principles to biomanufacturing - Practical examples of factors which can affect biopharmaceutical processes - Coverage of key factors which require integration to run an efficient biopharmaceutical process
Drawing on 40 years of application experience at one of the world's largest chemical and materials manufacturers, King provides the first comprehensive resource written explicitly for change agents within the process industries.
The Lean Manufacturing Implementation Guide is a "how to" book that describes and documents the proven steps necessary to complete a successful lean transformation in a manufacturing facility. It reduces the manufacturer's fear of change by providing proven, objective and standard how to methods that are understandable and can be easily applied. The book is designed for manufacturing and engineering management personnel.
This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.