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The Application Of Statistical Process Control In The Pharmaceutical And Biotechnology Industries
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Book Synopsis The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries by : T Cochrane
Download or read book The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries written by T Cochrane and published by Elsevier. This book was released on 2029-01-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative new technology now allows the measurement and collection of data throughout many manufacturing processes previously unavailable. The The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries is a starting point for anyone who has been tasked to use technology to measure and collect data to gain an understanding of their processes in order to improve and control lengthy, complex supply chains in the pharmaceutical industry. It is a practical guide on how to apply statistical process control (SPC) within the pharmaceutical industry. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way. This book delivers a way of viewing data that is both simple and easy to understand and relates to our understanding of the world in which we work. The first book to describe SPC in the pharmaceutical and biotechnology industries Highly practical approach Contains many case studies showing the application of SPC
Book Synopsis Statistical Process Control for the FDA-Regulated Industry by : Manuel E. Pena-Rodriguez
Download or read book Statistical Process Control for the FDA-Regulated Industry written by Manuel E. Pena-Rodriguez and published by Quality Press. This book was released on 2013-04-11 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the authors almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.
Book Synopsis Nonclinical Statistics for Pharmaceutical and Biotechnology Industries by : Lanju Zhang
Download or read book Nonclinical Statistics for Pharmaceutical and Biotechnology Industries written by Lanju Zhang and published by Springer. This book was released on 2016-01-13 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.
Book Synopsis PAT Applied in Biopharmaceutical Process Development And Manufacturing by : Cenk Undey
Download or read book PAT Applied in Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and published by CRC Press. This book was released on 2011-12-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Book Synopsis Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry by : Richard K. Burdick
Download or read book Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry written by Richard K. Burdick and published by Springer. This book was released on 2017-02-14 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Book Synopsis Process Monitoring and Quality by Design for Biotechnology Products by : Neslihan Delacruz
Download or read book Process Monitoring and Quality by Design for Biotechnology Products written by Neslihan Delacruz and published by Biota Publishing. This book was released on 2010-09-01 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use. Table of Contents: Abbreviations / Introduction / From the Traditional Development Path to Quality by Design / Continuous Process Verification and Process Monitoring / Process Monitoring and Statistical Control Limits / Multivariate Analysis: A Mature State of Statistical Process Monitoring / Conclusion / Bibliography
Book Synopsis Six Sigma in the Pharmaceutical Industry by : Brian K. Nunnally
Download or read book Six Sigma in the Pharmaceutical Industry written by Brian K. Nunnally and published by CRC Press. This book was released on 2007-06-13 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable health care. Traditional methodologies are failing and the industry needs to find new and innovative approaches for everything it does. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics is the first book to focus on the building blocks of understanding and reducing variation using the Six Sigma method as applied specifically to the pharmaceutical industry. It introduces the fundamentals of Six Sigma, examines control chart theory and practice, and explains the concept of variation management and reduction. Describing the approaches and techniques responsible for their own significant success, the authors provide more than just a set of tools, but the basis of a complete operating philosophy. Allowing other references to cover the structural elements of Six Sigma, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry. The first half of the book uses simple models and descriptions of practical experiments to lay out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Designed primarily for the pharmaceutical industry, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics provides the fundamentals of variation management and reduction in sufficient detail to assist in transforming established methodologies into new and efficient techniques.
Book Synopsis Statistical Applications in Process Control by : J. Bert Keats
Download or read book Statistical Applications in Process Control written by J. Bert Keats and published by CRC Press. This book was released on 1996-03-15 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work presents significant advances and new methods both in statistical process control and experimental design. It addresses the management of process monitoring and experimental design, discusses the relationship between control charting and hypothesis testing, provides a new index for process capability studies, offers practical guidelines for the design of experiments, and more.
Book Synopsis Statistics for Biotechnology Process Development by : Todd Coffey
Download or read book Statistics for Biotechnology Process Development written by Todd Coffey and published by CRC Press. This book was released on 2018-05-16 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.
Book Synopsis Statistical Process Control in Industry by : R.J. Does
Download or read book Statistical Process Control in Industry written by R.J. Does and published by Springer Science & Business. This book was released on 1999-01-31 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decade interest in quality management has greatly increased. One of the central elements of Total Quality Management is Statistical Process Control, more commonly known as SPC. This book describes the pitfalls and traps which businesses encounter when implementing and assuring SPC. Illustrations are given from practical experience in various companies. The following subjects are discussed: implementation of SPC, activity plan for achieving statistically controlled processes, statistical tools, and lastly, consolidation and improvement of the results. Also, an extensive checklist is provided with which a business can determine to what extent it has succeeded in the actual application of SPC. Audience: This volume is written for companies which are going to implement SPC, or which need a new impetus in order to get SPC properly off the ground. It will be of interest in particular to researchers whose work involves statistics and probability, production, operation and manufacturing management, industrial organisation and mathematical and quantitative methods. It will also appeal to specialists in engineering and management, for example in the electronic industry, discrete parts industry, process industry, automotive and aircraft industry and food industry.
Book Synopsis Statistical Process Control in Automated Manufacturing by : Bert Keats
Download or read book Statistical Process Control in Automated Manufacturing written by Bert Keats and published by CRC Press. This book was released on 2020-11-26 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an introduction to statistical process control in automated manufacturing and suggests implementation strategies. It focuses on time series applications in statistical process control and explores the role of knowledge-based systems in process control.
Book Synopsis Statistical Case Studies for Industrial Process Improvement by : Veronica Czitrom
Download or read book Statistical Case Studies for Industrial Process Improvement written by Veronica Czitrom and published by SIAM. This book was released on 1997-01-01 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains a broad selection of case studies written by professionals in the semiconductor industry that illustrate the use of statistical methods to improve manufacturing processes. These case studies offer engineers, scientists, technicians, and managers numerous examples of best-in-class practices by their peers. Because of the universal nature of statistical applications, the methods described here can be applied to a wide range of industries, including the chemical, biotechnology, automotive, steel, plastics, textile, and food industries. Many industries already benefit from the use of statistical methods, although the semiconductor industry is considered both a leader in and a model for the wide application and effective use of statistics.
Book Synopsis Statistical Process Control by : Leonard A. Doty
Download or read book Statistical Process Control written by Leonard A. Doty and published by Industrial Press Inc.. This book was released on 1996 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This in-depth introduction to SPC examines the technical aspects of the practices and procedures that are used to apply the quality management system in manufacturing. As in the successful first edition, the author provides a description and history of SPC along with an analysis of how it is applied to control quality costs, productivity, product improvement, and work efficiency. New to this edition are an explanation of seven basic tools, new charts, and an exploration of current trends.
Book Synopsis Statistical Process Control and Quality Improvement by : Gerald Smith
Download or read book Statistical Process Control and Quality Improvement written by Gerald Smith and published by Prentice Hall. This book was released on 2004 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: For freshman/sophomore level introductory courses in SPC (Statistical Process Control), Statistical Quality Control or Quality Control found in two and four-year college curriculums, and in industrial training programs. This mathematics-friendly text introduces students to basic concepts and applications of Statistical Process Control (SPC). Students get a solid foundation in control charts-including setting scales, charting, interpreting, and analyzing process capability. Problem-solving techniques are emphasized, and all learning is linked to the implementation of SPC in the workplace.
Book Synopsis Statistical Process Control by : John S Oakland
Download or read book Statistical Process Control written by John S Oakland and published by Routledge. This book was released on 2012-05-23 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: A highly successful title from one of the UK's leading exponents of TQM. The book features user-friendly presentation and reflects the latest thinking in the field. It will serve as a textbook for self or group instruction for both student and practicing engineers, scientists, technologists and managers and will prove invaluable to all. Statistical process control is a tool, which enables both manufacturers and suppliers to achieve control of product quality by means of the application of statistical methods in the controlling process. This book gives the foundations of good quality management and process control, including an explanation of what quality is, and control of conformance and consistency during production. The text offers clear guidance and help to those unfamiliar with either quality control or statistical applications and coves all the necessary theory and techniques in a practical and non-mathematical manner. This book will be essential reading for anyone wishing to understand or implement modern statistical process control techniques.
Book Synopsis Statistical Process Control for the Food Industry by : Sarina A. Lim
Download or read book Statistical Process Control for the Food Industry written by Sarina A. Lim and published by John Wiley & Sons. This book was released on 2019-03-08 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive treatment for implementing Statistical Process Control (SPC) in the food industry This book provides managers, engineers, and practitioners with an overview of necessary and relevant tools of Statistical Process Control, a roadmap for their implementation, the importance of engagement and teamwork, SPC leadership, success factors of the readiness and implementation, and some of the key lessons learned from a number of food companies. Illustrated with numerous examples from global real-world case studies, this book demonstrates the power of various SPC tools in a comprehensive manner. The final part of the book highlights the critical challenges encountered while implementing SPC in the food industry globally. Statistical Process Control for the Food Industry: A Guide for Practitioners and Managers explores the opportunities to deliver customized SPC training programs for local food companies. It offers insightful chapter covering everything from the philosophy and fundamentals of quality control in the food industry all the way up to case studies of SPC application in the food industry on both the quality and safety aspect, making it an excellent "cookbook" for the managers in the food industry to assess and initiating the SPC application in their respective companies. Covers concise and clear guidelines for the application of SPC tools in any food companies' environment Provides appropriate guidelines showing the organizational readiness level before the food companies adopt SPC Explicitly comments on success factors, motivations, and challenges in the food industry Addresses quality and safety issues in the food industry Presents numerous, global, real-world case studies of SPC in the food industry Statistical Process Control for the Food Industry: A Guide for Practitioners and Managers can be used to train upper middle and senior managers in improving food quality and reducing food waste using SPC as one of the core techniques. It's also an excellent book for graduate students of food engineering, food quality management and/or food technology, and process management.
Book Synopsis GMP Audits in Pharmaceutical and Biotechnology Industries by : Mustafa Edik
Download or read book GMP Audits in Pharmaceutical and Biotechnology Industries written by Mustafa Edik and published by CRC Press. This book was released on 2024-06-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
