Download or read book Electronic Batch Recording Solutions written by Monika Futschik and published by Springer. This book was released on 2017-10-11 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monika Futschik introduces an evaluation model that allows a holistic assessment of the advantages and disadvantages of electronic batch recording solutions versus traditional paper batch ticket solutions. In comparison to former studies, this newly developed evaluation model considers the change management efforts and the financial investments required for system deployment. The model proves the overall performance value through the implementation of electronic batch recording solutions and supports decision-makers in finding the most effective solution. The development and effectiveness of this model is based on various surveys, expert interviews, a Delphi study as well as a case study with a real-life pharmaceutical company. The outcome of her research can be easily applied to other industries as well.

Download or read book Instrument Engineers Handbook Volume 3 written by Bela G. Liptak and published by CRC Press. This book was released on 2018-10-08 with total page 1140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Instrument Engineers' Handbook – Volume 3: Process Software and Digital Networks, Fourth Edition is the latest addition to an enduring collection that industrial automation (AT) professionals often refer to as the "bible." First published in 1970, the entire handbook is approximately 5,000 pages, designed as standalone volumes that cover the measurement (Volume 1), control (Volume 2), and software (Volume 3) aspects of automation. This fourth edition of the third volume provides an in-depth, state-of-the-art review of control software packages used in plant optimization, control, maintenance, and safety. Each updated volume of this renowned reference requires about ten years to prepare, so revised installments have been issued every decade, taking into account the numerous developments that occur from one publication to the next. Assessing the rapid evolution of automation and optimization in control systems used in all types of industrial plants, this book details the wired/wireless communications and software used. This includes the ever-increasing number of applications for intelligent instruments, enhanced networks, Internet use, virtual private networks, and integration of control systems with the main networks used by management, all of which operate in a linked global environment. Topics covered include: Advances in new displays, which help operators to more quickly assess and respond to plant conditions Software and networks that help monitor, control, and optimize industrial processes, to determine the efficiency, energy consumption, and profitability of operations Strategies to counteract changes in market conditions and energy and raw material costs Techniques to fortify the safety of plant operations and the security of digital communications systems This volume explores why the holistic approach to integrating process and enterprise networks is convenient and efficient, despite associated problems involving cyber and local network security, energy conservation, and other issues. It shows how firewalls must separate the business (IT) and the operation (automation technology, or AT) domains to guarantee the safe function of all industrial plants. This book illustrates how these concerns must be addressed using effective technical solutions and proper management policies and practices. Reinforcing the fact that all industrial control systems are, in general, critically interdependent, this handbook provides a wide range of software application examples from industries including: automotive, mining, renewable energy, steel, dairy, pharmaceutical, mineral processing, oil, gas, electric power, utility, and nuclear power.

Download or read book SAP S 4HANA Supply Chain Planning and Manufacturing written by Dr. Ankush Agrawal and published by BPB Publications. This book was released on 2023-11-21 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discovering features and functionalities in SAP IBP and SAP S/4HANA Manufacturing KEY FEATURES ● Delve into the core functionalities of SAP S/4HANA for supply chain planning and manufacturing. ● Harness the power of SAP IBP to forecast demand, optimize supply, and manage inventory with precision. ● Explore the intricacies of SAP S/4HANA Manufacturing, streamlining production planning, execution, and quality management. ● Leverage AI and ML to enhance demand forecasting, optimize schedules, automate tasks, and gain real-time visibility. DESCRIPTION Embark on a transformative journey with SAP S/4HANA Supply Chain Planning and Manufacturing, your comprehensive guide to mastering the latest advancements in supply chain management. Step into the world of SAP S/4HANA and conquer the complexities of demand-driven planning, production optimization, and quality control. Unlock the secrets of SAP IBP, a cloud-based powerhouse that empowers you to forecast demand with precision, optimize supply chains seamlessly, and manage inventory levels effortlessly. Master the intricacies of SAP S/4HANA Manufacturing, harnessing its capabilities to streamline production planning, execute orders efficiently, and ensure impeccable product quality. Embrace the transformative power of AI and ML, leveraging these cutting-edge technologies to enhance demand forecasting, optimize production schedules, automate repetitive tasks, and gain real-time visibility into your supply chain operations. Whether you are a seasoned supply chain professional or just starting your journey, this book is your indispensable companion, providing a clear and concise roadmap to success. WHAT YOU WILL LEARN ● Master the art of demand-driven planning, ensuring optimal production and inventory levels. ● Learn about the latest advancements in planning, manufacturing, and quality control. ● Understand the planning journey along with SAP S/4HANA and SAP IBP. ● Gain the knowledge and skills to become a sought-after supply chain expert, equipped to navigate the ever-evolving landscape of supply chain management. WHO THIS BOOK IS FOR This book is designed for the supply chain professionals, including business users, functional and technical consultants, and program managers, who are seeking to transform their supply chain to an integrated digital supply chain planning and manufacturing in SAP S/4HANA and IBP. Prior knowledge of SAP S/4HANA and IBP is not required. However, a basic understanding of supply chain management principles and terminology would be beneficial. TABLE OF CONTENTS 1. Exploring Planning and Manufacturing in S/4HANA 2. Uncovering Inter-connected Business Process through SAP S/4HANA 3. SAP S/4HANA Planning and Manufacturing Capabilities 4. Getting Started with SAP Integrated Business Planning 5. Implementing and Configuring SAP IBP 6. Getting Started with SAP S/4HANA Manufacturing 7. Configuring SAP S/4HANA Manufacturing 8. Understanding SAP Digital Manufacturing Cloud 9. SAP S/4HANA Advance Planning: aATP and ePPDS 10. Implementing SAP S/4HANA ePPDS and aATP 11. SAP S/4HANA Advance Manufacturing Features 12. Implementation Methodologies, Assessments, and Tools 13. Data Integration with SAP IBP and SAP S/4HANA Manufacturing 14. AI, ML, Analytics, and Robotic Process Automation 15. SAP Best Practices

Download or read book Sterile Processing of Pharmaceutical Products written by Sam A. Hout and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: Covers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements Addresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH Provides techniques for systematic process optimization and good manufacturing practice Emphasizes the importance of attention to detail in process development and validation Features real-world examples highlighting different aspects of drug manufacturing Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.

Download or read book Innovative Logistics Services and Sustainable Lifestyles written by Ani Melkonyan and published by Springer. This book was released on 2019-02-26 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited volume aims to describe the transformation of supply chain management (SCM) and logistics services by merging sustainable logistics, SCM, sustainable consumption and lifestyle research. This assessment of the transformation potential serves the development of sustainable business models and optimized decision-making systems for achieving sustainable economic value creation within a green economy. In 5 sections, the volume takes a unique transdisciplinary approach to assess sustainable business practices within SCM and the logistics sector, and to understand the interactions between logistics services and consumer lifestyles while creating transparency within the decision making process. This book will be of particular interest to academics, policymakers, planners, and politicians. Section 1 introduces readers to the importance of blended research and innovation between sustainable SCM and consumer lifestyles for transformation towards a green economy. Section 2 addresses the question of how trends and developments in consumption behavior and lifestyles influence the development of sustainable logistics. Section 3 discusses the transformation potential towards sustainable logistics using the food sector as an example. Section 4 focuses on strategic decision making in SCM, and how long-term improvements of sustainability performance can be achieved. Section 5 concludes with policy recommendations as well as research and innovation perspectives for future sustainable development with SCM and logistics.

Download or read book Sterile Manufacturing written by Sam A. Hout and published by CRC Press. This book was released on 2021-07-04 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1310 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Electronic Resource Management in Libraries Research and Practice written by Yu, Holly and published by IGI Global. This book was released on 2008-02-28 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: A pronounced move from print subscriptions to electronic resources in all types of libraries has fundamentally impacted the library and its users. With the influx of resources such as e-journals; e-books; index, abstract, and/or full-text databases; aggregated databases; and others, the shift to electronic resources is rapidly changing library operational and organizational procedures. Electronic Resource Management in Libraries: Research and Practice provides comprehensive coverage of the issues, methods, theories, and challenges connected with the provision of electronic resources in libraries, with emphasis on strategic planning, operational guidelines, and practices. This book primarily focuses on management practices of the life-cycle of commercially acquired electronic resources from selection and ordering to cataloging, Web presentation, user support, usage evaluation, and more.

Download or read book Manufacturing of Quality Oral Drug Products written by Sam A. Hout and published by CRC Press. This book was released on 2022-06-27 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.

Download or read book Digital Transformation of Animal Health Data Proceedings of the AHEAD 2017 Workshop written by Flavie Vial and published by Frontiers Media SA. This book was released on 2018-08-30 with total page 63 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Organisation for Economic Co-operation and Development (OECD)’s Co-operative Research Programme on Biological Resource Management for Sustainable Agricultural Systems sponsored the AHEAD 2017 workshop, bringing together experts from the farming and pharmaceutical industries, information and communications technology, policy, research (and more) to create a roadmap to the digital transformation of animal health surveillance. In many countries, policy supports the reduction of antibiotic use and a growing focus in the veterinary practice is to move away from blanket dosage of antibiotics, for example for mastitis. Significant and speedy improvements can take place, but only with coordinated actions supported by the entire value chain. Reducing the use of antibiotics is of massive societal importance, but changing on farm or veterinary methods requires thought and a user-centred approach. The most glaring and addressable challenge is the absence of near real-time data and information. AHEAD 2017 explored how governments globally can benefit from increased digitisation in animal health. For effective monitoring, it is important to first understand the relevant tasks of each stakeholder in the food value chain. In these proceedings we openly discuss and define these tasks, identify existing challenges to completion of these tasks, and suggest the business opportunities overcoming these challenges can create. Through this publication, it is our intention to encourage open discussion, design and co-creation of an improved digital approach to animal health and drug usage in agriculture. The Workshop was sponsored by the OECD Co-operative Research Programme on Biological Resource Management for Sustainable Agricultural Systems, whose financial support made it possible for most of the invited speakers to participate in the Workshop. The opinions expressed and arguments employed in this publication are the sole responsibility of the authors and do not necessarily reflect those of the OECD or of the governments of its Member countries.

Download or read book Manufacturing of Pharmaceutical Proteins written by Stefan Behme and published by John Wiley & Sons. This book was released on 2022-04-18 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: An expert, single-volume overview of the core processes and disciplines of biopharmaceutical production In the newly revised Third Edition of Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control. Suitable as both a reference book and a training resource, this book extensively explores the impact of digital transformation on pharmaceutical protein manufacturers and includes a brand-new chapter dedicated to digitalization. The distinguished author provides readers with practical understanding of the terminology and principles driving the various fields involved with biotechnological production, including operations, legal, finance, and IT. He also offers: A thorough introduction to biopharmaceutical production, including value creation, product types, and biological basics Comprehensive explorations of the technology of the manufacturing process and analytics Practical discussions of pharmacology and drug safety, quality assurance, and pharmaceutical law In-depth examinations of pharmaceutical protein production facilities, including facility design and the planning, construction, and commissioning of a manufacturing plant Perfect for biotechnologists working in the pharmaceutical industry, Manufacturing of Pharmaceutical Proteins: From Technology to Economy will also earn a place in the libraries of pharmaceutical engineers seeking a one-stop reference for all aspects of biopharmaceutical production.

Download or read book The Computer System Risk Management and Validation Life Cycle written by R. Timothy Stein and published by Paton Professional. This book was released on 2006 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book THE WBF BOOK SERIES Applying ISA 88 In Discrete and Continuous Manufacturing written by The WBF and published by Momentum Press. This book was released on 2010-12-13 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE WBF BOOK SERIES-APPLYING ISA 88 In Discrete and Continuous Manufacturing features: * How to apply ISA 88 batch recipes to continuous and semi-continuous manufacturing processes * How to use ISA 88 recipes for packaging of consumer packaged goods and defining a Compliant Packaging Environment * Examples of applying ISA 88 and 99 to manufacturing and packaging systems integration. ISA (International Society of Automation) standards 88 and 95 are manufacturing standards established in the late 1990s and periodically updated by the governing bodies responsible for them--the Instrumentation Society of America and the American National Standards Institute). The two standards set up protocols and uniform specifications for batch control systems, including types of control equipment, design of control systems and interpretation of batch control data. In Volume 3, the reader will find innovative applications of ISA batch recipes to continuous and semi-continuous manufacturing operations, as well as how to integrate with ISA 95 standards for total integrated manufacturing automation. The ISA 88 and 95 standards have been around (and periodically updated) for nearly 20 years now, but little really helpful has been published on how to put those standards into use, particularly from a pragmatic, real-life experience point of view. The four books in this new series will do exactly that: explain to the manufacturing engineer, the controls engineers, and the industrial planner and manager alike how these standards translate into improved batch and continuous process operations--and ultimately how those operations can be integrated and automate into the general business operations (accounting, inventory, customer relations, product development) of the manufacturing concern.

Download or read book Control Solutions written by and published by . This book was released on 2001 with total page 856 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Innovation in Life Sciences written by Avo Schönbohm and published by Springer Nature. This book was released on with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Parenteral Medications Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.