Pharmaceutical Process Design And Management

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Pharmaceutical Process Design and Management

Kate McCormick,D. Wylie McVay Jr
Pharmaceutical Process Design and Management Book PDF

Author : Kate McCormick,D. Wylie McVay Jr
Publisher : Routledge
Page : 288 pages
File Size : 43,5 Mb
Release : 2016-04-22
Category : Business & Economics
ISBN : 9781317081401

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Pharmaceutical Process Design and Management by Kate McCormick,D. Wylie McVay Jr Pdf

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

Pharmaceutical Process Design and Management

Kate McCormick,D. Wylie McVay Jr
Pharmaceutical Process Design and Management Book PDF

Author : Kate McCormick,D. Wylie McVay Jr
Publisher : Routledge
Page : 262 pages
File Size : 46,8 Mb
Release : 2016-04-22
Category : Business & Economics
ISBN : 9781317081395

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Pharmaceutical Process Design and Management by Kate McCormick,D. Wylie McVay Jr Pdf

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

Pharmaceutical Operations Management

Pankaj Mohan,Jarka Glassey,Gary A. Montague
Pharmaceutical Operations Management Book PDF

Author : Pankaj Mohan,Jarka Glassey,Gary A. Montague
Publisher : McGraw-Hill Professional
Page : 264 pages
File Size : 50,7 Mb
Release : 2006-03-16
Category : Business & Economics
ISBN : 9780071472494

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Pharmaceutical Operations Management by Pankaj Mohan,Jarka Glassey,Gary A. Montague Pdf

Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.

Pharmaceutical Quality by Design

Walkiria S. Schlindwein,Mark Gibson
Pharmaceutical Quality by Design Book PDF

Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Page : 375 pages
File Size : 55,5 Mb
Release : 2018-03-19
Category : Science
ISBN : 9781118895207

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Pharmaceutical Quality by Design by Walkiria S. Schlindwein,Mark Gibson Pdf

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Process Systems Engineering for Pharmaceutical Manufacturing

Ravendra Singh,Zhihong Yuan
Process Systems Engineering for Pharmaceutical Manufacturing Book PDF

Author : Ravendra Singh,Zhihong Yuan
Publisher : Elsevier
Page : 698 pages
File Size : 40,9 Mb
Release : 2018-03-16
Category : Technology & Engineering
ISBN : 9780444639660

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Process Systems Engineering for Pharmaceutical Manufacturing by Ravendra Singh,Zhihong Yuan Pdf

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book PDF

Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Page : 416 pages
File Size : 43,8 Mb
Release : 2017-08-30
Category : Science
ISBN : 9781119356165

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Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz Pdf

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Pharmaceutical Quality by Design

Sarwar Beg,Md Saquib Hasnain
Pharmaceutical Quality by Design Book PDF

Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Page : 448 pages
File Size : 43,7 Mb
Release : 2019-03-27
Category : Business & Economics
ISBN : 9780128163726

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Pharmaceutical Quality by Design by Sarwar Beg,Md Saquib Hasnain Pdf

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Pharmaceutical Product Development

Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Pharmaceutical Product Development Book PDF

Author : Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Publisher : CRC Press
Page : 433 pages
File Size : 53,9 Mb
Release : 2016-05-25
Category : Medical
ISBN : 9781498730785

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Pharmaceutical Product Development by Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee Pdf

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Quality by Design for Biopharmaceutical Drug Product Development

Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
Quality by Design for Biopharmaceutical Drug Product Development Book PDF

Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
Publisher : Springer
Page : 710 pages
File Size : 52,9 Mb
Release : 2015-04-01
Category : Medical
ISBN : 9781493923168

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Quality by Design for Biopharmaceutical Drug Product Development by Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe Pdf

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Pharmaceutical Process Engineering

Anthony J. Hickey,David Ganderton
Pharmaceutical Process Engineering Book PDF

Author : Anthony J. Hickey,David Ganderton
Publisher : CRC Press
Page : 230 pages
File Size : 53,6 Mb
Release : 2016-03-09
Category : Medical
ISBN : 9781420084764

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Pharmaceutical Process Engineering by Anthony J. Hickey,David Ganderton Pdf

With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmac

Biopharmaceutical Processing

Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
Biopharmaceutical Processing Book PDF

Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
Publisher : Elsevier
Page : 1308 pages
File Size : 53,8 Mb
Release : 2018-01-18
Category : Technology & Engineering
ISBN : 9780128125526

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Biopharmaceutical Processing by Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher Pdf

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Global Supply Chains in the Pharmaceutical Industry

Nozari, Hamed,Szmelter, Agnieszka
Global Supply Chains in the Pharmaceutical Industry Book PDF

Author : Nozari, Hamed,Szmelter, Agnieszka
Publisher : IGI Global
Page : 373 pages
File Size : 43,7 Mb
Release : 2018-11-09
Category : Business & Economics
ISBN : 9781522559221

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Global Supply Chains in the Pharmaceutical Industry by Nozari, Hamed,Szmelter, Agnieszka Pdf

In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.

PAT Applied in Biopharmaceutical Process Development And Manufacturing

Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
PAT Applied in Biopharmaceutical Process Development And Manufacturing Book PDF

Author : Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
Publisher : CRC Press
Page : 330 pages
File Size : 55,9 Mb
Release : 2011-12-07
Category : Medical
ISBN : 9781439829455

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PAT Applied in Biopharmaceutical Process Development And Manufacturing by Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch Pdf

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.

The Management of Chemical Process Development in the Pharmaceutical Industry

Derek Walker
The Management of Chemical Process Development in the Pharmaceutical Industry Book PDF

Author : Derek Walker
Publisher : John Wiley & Sons
Page : 424 pages
File Size : 47,5 Mb
Release : 2008-03-03
Category : Medical
ISBN : 9780470259504

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The Management of Chemical Process Development in the Pharmaceutical Industry by Derek Walker Pdf

Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on: Directing and carrying out specific tasks and courses of action Making and communicating clear and achievable decisions Solving problems on the spot Managing the administrative aspects of chemical process development The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into: Understanding the workings of matrix organizations Defining missions and creating action plans Developing interdisciplinary approaches to problem solving Holding review meetings, revising goals, and motivating staff Prioritizing programs and responses to emergencies In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development

Márcia Cristina Breitkreitz,Hector Goicoechea
Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development Book PDF

Author : Márcia Cristina Breitkreitz,Hector Goicoechea
Publisher : Springer Nature
Page : 268 pages
File Size : 53,9 Mb
Release : 2023-07-13
Category : Medical
ISBN : 9783031315053

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Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development by Márcia Cristina Breitkreitz,Hector Goicoechea Pdf

Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.