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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.
Draws conclusions for the future of the industry in the USA.
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.
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
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.​
Within manufacturing, Lean has lead to significant results throughout the world. But what happens when Lean meets Innovation? Is the needed creativity destroyed, or can Lean make the results of the organization even better? In Lean Innovation, Claus Sehested and Henrik Sonnenberg reveal how a managed iteration between creativity and effectiveness can ensure that the visions of top management are realized through the innovation processes. Lean can elevate the innovation processes to a new level where they become a true strategic differentiator. The authors address the key challenges facing leaders of knowledge organizations, and present a number of principles which they can use to bring more leadership into the innovation work. They also discuss methods which can increase result focus and continuous learning in the core innovation processes. The book contains specific and practical examples from five companies who started on a Lean Innovation journey. Innovation Insights from Apple, Google, Toyota, IDEO and others are also included.
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.
This book demonstrates how to successfully manage and lead healthcare institutions by employing the logic of business model innovation to gain competitive advantages. Since clerk-like routines in professional organizations tend to overlook patient and service-centered healthcare solutions, it challenges the view that competition and collaboration in the healthcare sector should not only incorporate single-end services, therapies or diagnosis related groups. Moreover, the authors focus on holistic business models, which place greater emphasis on customer needs and put customers and patients first. The holistic business models approach addresses topics such as business operations, competitiveness, strategic business objectives, opportunities and threats, critical success factors and key performance indicators.The contributions cover various aspects of service business innovation such as reconfiguring the hospital business model in healthcare delivery, essential characteristics of service business model innovation in healthcare, guided business modeling and analysis for business professionals, patient-driven service delivery models in healthcare, and continuous and co-creative business model creation. All of the contributions introduce business models and strategies, process innovations, and toolkits that can be applied at the managerial level, ensuring the book will be of interest to healthcare professionals, hospital managers and consultants, as well as scholars, whose focus is on improving value-generating and competitive business architectures in the healthcare sector.