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

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 author’s 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.

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.

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 705 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.

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.

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

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.

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.

Download or read book Application of Information Technology and Statistical Process Control in Pharmaceutical Quality Assurance Compliance written by Asvin Srinivasan and published by . This book was released on 2011 with total page 67 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recently, the FDA issued new quality guidelines (Q10) encouraging drug manufacturers to improve their quality monitoring procedures. This renewed focus on quality and risk management has prompted Novartis to re-evaluate their systems and procedures to ensure compliance with the proposed guidelines. The company has chosen to respond by introducing more advanced statistical analysis of the data they share with regulatory bodies through the Annual Product Review (APR). However, procedural changes alone cannot bring about the needed innovation. Currently, too much time is spent on data consolidation and other non-value added tasks allowing less time for analysis. The solution is an Information Technology system with new procedures that will both improve process quality and increase productivity. The design proposed in this thesis utilizes statistical software that can analyze data securely, automatically generate graphs, and display alerts through an online dashboard. This Decision Support System will be integrated into Novartis's Global APR Automation project which aims to automate the generation of the entire APR document. A dashboard feature will allow processes to be monitored continuously instead of annually. The final version of the system will also include content management systems, business warehousing, audit validation and business intelligence tools. In addition to software, alternate statistical methods are proposed for evaluating critical processes that are either not in statistical control or lack normal distributions. These methods together with the new IT tools should help Novartis address process exceptions and reduce process variation without overloading the organization.

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.

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.

Download or read book Multivariate Analysis in the Pharmaceutical Industry written by Ana Patricia Ferreira and published by Academic Press. This book was released on 2018-04-24 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Download or read book Introduction to Statistical Process Control written by Muhammad Aslam and published by John Wiley & Sons. This book was released on 2020-09-16 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: An Introduction to the Fundamentals and History of Control Charts, Applications, and Guidelines for Implementation Introduction to Statistical Process Control examines various types of control charts that are typically used by engineering students and practitioners. This book helps readers develop a better understanding of the history, implementation, and use-cases. Students are presented with varying control chart techniques, information, and roadmaps to ensure their control charts are operating efficiently and producing specification-confirming products. This is the essential text on the theories and applications behind statistical methods and control procedures. This eight-chapter reference breaks information down into digestible sections and covers topics including: ● An introduction to the basics as well as a background of control charts ● Widely used and newly researched attributes of control charts, including guidelines for implementation ● The process capability index for both normal and non-normal distribution via the sampling of multiple dependent states ● An overview of attribute control charts based on memory statistics ● The development of control charts using EQMA statistics For a solid understanding of control methodologies and the basics of quality assurance, Introduction to Statistical Process Control is a definitive reference designed to be read by practitioners and students alike. It is an essential textbook for those who want to explore quality control and systems design.

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.

Download or read book Using Applied Statistics to Study a Pharmaceutical Manufacturing Process written by John P. Tiani and published by . This book was released on 2004 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: Abstract: The pharmaceutical manufacturing process of interest produces a suspension for inhalation. Currently, the product is manufactured on two lines. A third and fourth line are in the process of being commissioned and plans are currently in place to construct three additional lines. The manufacturing lines operate independently of one another. Each manufacturing line consists of two actives compounding tanks so their utilization can be rotated to improve manufacturing capacity. The objective of this project was to study the content uniformity assay values for the 0.25 mg/mL (0.5 mg) manufacturing process through the application of statistical techniques. The study focused on three separate topics: 1. Monitoring process behavior for content uniformity assay values 2. Ascertaining the equivalence of batches manufactured on Line 1 vs Line 2. 3. Monitoring the signal to noise ratio of the content uniformity assay values In order to accomplish the three tasks above, the following statistical techniques were applied: 1. Control chart techniques were applied to the data, including standard control chart techniques (x-bar and S), individuals control chart techniques, and modified limits. 2. An equivalence test for the means of the two processes was conducted. 3. A new control chart, the SNR chart, was developed and implemented. The results/conclusions of the application of statistical techniques were: 1. The content uniformity assay values were in statistical process control with respect to modified limit control chart techniques. 2. The Line 1 and 2 data were statistically equivalent. 3. The quantity (x-bar / s) was in statistical process control. The SNR control chart displayed superior performance to the Individuals control chart.

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 383 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.

Download or read book Statistical Process Control for Real World Applications written by William A. Levinson and published by CRC Press. This book was released on 2010-12-21 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: The normal or bell curve distribution is far more common in statistics textbooks than it is in real factories, where processes follow non-normal and often highly skewed distributions. Statistical Process Control for Real-World Applications shows how to handle non-normal applications scientifically and explain the methodology to suppliers and custom