Download or read book Lean Manufacturing In Pharmaceutical Industry written by Ntin Kapoor and published by Lulu.com. This book was released on 2013-11-20 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Leading Pharmaceutical Operational Excellence written by Thomas Friedli and published by Springer Science & Business Media. This book was released on 2013-11-26 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Study of Scope and Implementation of Lean Aspects in Pharmaceutical Industry written by V. Jaiganesh and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Lean Six Sigma in the Pharmaceutical Industry written by William Botha and published by . This book was released on 2013-07-19 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Lean for the Process Industries written by Peter L. King and published by CRC Press. This book was released on 2019-06-05 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: Compared to its widespread implementation across almost all areas of production, Lean improvement efforts lag within the process industries. While many innovators have successfully applied Lean principles to these industries during the past three decades, most of those pioneering efforts were never recorded to guide the improvement efforts of others. Drawing on more than 40 years of application experience at one of the world’s largest chemical and materials manufacturers, coupled with 10 years in private practice, Peter King corrects this void by providing the first comprehensive resource written explicitly for change agents within the process industries. Focusing on areas where the improvement needs of the process industry differ from parts assembly manufacturing, Lean for the Process Industries: Dealing with Complexity, Second Edition: Covers each of the eight wastes commonly described in Lean literature, looking at how they manifest themselves in process operations. Explains how to adapt value stream mapping for process operations. Shows how to identify the root causes of bottlenecks, and how to manage them to optimize flow until they can be eliminated. Provides practical techniques to overcome the barriers which have prevented the application of Cellular Manufacturing to process operations. Discusses the role of business leadership in a Lean strategy, describing both enabling and counter-productive management behaviors Since the publication of the first edition of this book, Peter King has been busy consulting with food, beverage, gasoline additive, and nutraceutical companies -- these new experiences have broadened his perspectives on certain Lean processes and have given him a richer set of examples to discuss in this new edition. While Value Stream Mapping is a very powerful tool to understand flow, bottlenecks, and waste in an operation, the traditional format as presented in many other books does not describe all of the data required to fully understand process flow and its detractors. This new edition highlights the necessary additions with examples of why they are useful. Product wheel scheduling achieves production leveling in a far more comprehensive and effective way than traditional heijunka methods. This edition has a more thorough description of the wheel concept and design steps, and more examples from actual applications.
Download or read book Lean Biomanufacturing written by Nigel J Smart and published by Elsevier. This book was released on 2013-10-31 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Creating a Lean R D System written by Terence Barnhart and published by CRC Press. This book was released on 2012-08-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Six Sigma written by Abdurrahman Coskun and published by BoD – Books on Demand. This book was released on 2011-07-14 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the new millennium the increasing expectation of customers and products complexity has forced companies to find new solutions and better alternatives to improve the quality of their products. Lean and Six Sigma methodology provides the best solutions to many problems and can be used as an accelerator in industry, business and even health care sectors. Due to its flexible nature, the Lean and Six Sigma methodology was rapidly adopted by many top and even small companies. This book provides the necessary guidance for selecting, performing and evaluating various procedures of Lean and Six Sigma. In the book you will find personal experiences in the field of Lean and Six Sigma projects in business, industry and health sectors.
Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Creating a Lean R D System written by Terence M Barnhart and published by CRC Press. This book was released on 2012-08-20 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 knowledge gaps appear in their projects, or have uncoordinated knowledge transfers that waste minutes, days, and even months every year. Creating a Lean R&D System: Lean Principles and Approaches for Pharmaceutical and Research-Based Organizations lays out the logic of why Lean implementation isn’t strictly for manufacturing and describes why it can be just as effective in R&D organizations. Terence Barnhart, former senior director of continuous improvement at Pfizer R&D, describes the theoretical and physical underpinnings of creating a Lean transformation in any R&D organization, as exemplified by the Lean transformation initiated within the R&D division of a global pharmaceutical company. Describing how to merge Lean principles with the cultural virtues inherent in R&D, the book presents Lean approaches that can be easily applied in pharmaceutical and research-based organizations. It takes a strategic approach to solving two problems unique to the Lean field. The first is in noting the key distinctions between R&D and manufacturing, and developing a Lean approach specific to the R&D environment. The second is that it proposes a systematic middle-out (merger/maneuver) strategy to help you initiate and sustain a Lean culture within your pharmaceutical R&D organization that will help you immediately engage all stakeholders involved.
Download or read book Lean Manufacturing Implementation written by Dennis P. Hobbs and published by J. Ross Publishing. This book was released on 2003-09-15 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Customer Centric Enterprise written by Mitchell M. Tseng and published by Springer Science & Business Media. This book was released on 2011-06-27 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: Companies are being forced to react to the growing individualization of demand. At the same time, cost management remains of paramount importance due to the competitive pressure in global markets. Thus, making enterprises more customer centric efficiently is a top management priority in most industries. Mass customization and personalization are key strategies to meet this challenge. Companies like Procter&Gamble, Lego, Nike, Adidas, Land's End, BMW, or Levi Strauss, among others, have started large-scale mass customization programs. This book provides insight into the different aspects of building a customer centric enterprise. Following an interdisciplinary approach, leading scientists and practitioners share their findings, concepts, and strategies from the perspective of design, production engineering, logistics, technology and innovation management, customer behavior, as well as marketing.
Download or read book Kaizen for Pharmaceutical Medical Device and Biotech Industries written by Shruti Bhat and published by ISBN Canada. This book was released on 2017-04-05 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector. Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, 'as is' Kaizen practices from auto sector won't work for pharmaceutical, medical device, and biotech organizations. Kaizen needs to be customized for these life science industries, to achieve its full benefits. So far, there has been no book on Kaizen that is customized for such industries. For over a decade, the author, Dr. Shruti Bhat has successfully completed more than 250 Kaizen, Lean Six Sigma and other continuous improvement projects worldwide within pharmaceuticals NHP, medical devices, biotech and healthcare sectors, and felt it will be beneficial to share those techniques and experiences. In addition to explaining all the general Kaizen process features, implementation, and application, this book also provides a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device and biotech companies. This book will be most applicable to small to medium-size companies. It will demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech and all life sciences organizations, irrespective of their size or workplace culture. It will also provide practical and useful examples and case studies of Kaizen principles that can be executed at various levels across the organization as well as for yourself as an individual to further your personal career. And last but not the least, it will help to improve revenues and create a lasting profitable change by using Kaizen principles and techniques.
Download or read book The Implementation of Lean Manufacturing and Process Oriented Organisation in a Multi national Pharmaceutical Company written by Sarah-Jane Cullinane and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Early Drug Development 2 Volume Set written by Fabrizio Giordanetto and published by John Wiley & Sons. This book was released on 2018-12-10 with total page 810 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Knowledge Management in the Pharmaceutical Industry written by Elisabeth Goodman and published by Routledge. This book was released on 2016-04-22 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pharmaceutical Industry has been undergoing a major transformation since the heady days of 'big pharma' in the 1970s and 80s. Patent expiry, the rise of generics, and the decline of the blockbuster drug have all changed the landscape over the last 10-15 years. It's an environment where products can take 10 years or more to come to market, billions are spent on research and development, jobs are being shed in the western pharma homelands and regulators and the public are more demanding than ever. So what part is Knowledge Management playing and going to play in this vital international industry? Knowledge Management (KM) has many facets from providing comprehensive knowledge bases for workers, through the sharing of advice and problem solving, to providing an environment for innovation and change. This book, focusing on research and development, and manufacturing-based companies, explores how a range of techniques and approaches have been applied in the unique environment of the Pharmaceutical Industry, and examine how it can help the industry in the 21st century. Whilst the book is centered on the Pharmaceutical Industry, its objective will be to discuss and demonstrate how Knowledge Management can be applied in a variety of environments, and with a range of cultural issues. KM practitioners, and potential practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from both the examples of good practice and the lessons learned by the authors and contributors.
