Electronic Batch Recording Solutions

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Author :
Publisher : Springer
ISBN 13 : 3658198192
Total Pages : 283 pages
Book Rating : 4.6/5 (581 download)

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Book Synopsis Electronic Batch Recording Solutions by : Monika Futschik

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.

Innovative Logistics Services and Sustainable Lifestyles

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Publisher : Springer
ISBN 13 : 3319984675
Total Pages : 315 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Innovative Logistics Services and Sustainable Lifestyles by : Ani Melkonyan

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 315 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.

Innovation in Life Sciences

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Author :
Publisher : Springer Nature
ISBN 13 : 3031477685
Total Pages : 272 pages
Book Rating : 4.0/5 (314 download)

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Book Synopsis Innovation in Life Sciences by : Avo Schönbohm

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:

Ontology-Based Development of Industry 4.0 and 5.0 Solutions for Smart Manufacturing and Production

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Author :
Publisher : Springer Nature
ISBN 13 : 3031474449
Total Pages : 277 pages
Book Rating : 4.0/5 (314 download)

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Book Synopsis Ontology-Based Development of Industry 4.0 and 5.0 Solutions for Smart Manufacturing and Production by : János Abonyi

Download or read book Ontology-Based Development of Industry 4.0 and 5.0 Solutions for Smart Manufacturing and Production written by János Abonyi and published by Springer Nature. This book was released on 2024-01-01 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a comprehensive framework for developing Industry 4.0 and 5.0 solutions through the use of ontology modeling and graph-based optimization techniques. With effective information management being critical to successful manufacturing processes, this book emphasizes the importance of adequate modeling and systematic analysis of interacting elements in the era of smart manufacturing. The book provides an extensive overview of semantic technologies and their potential to integrate with existing industrial standards, planning, and execution systems to provide efficient data processing and analysis. It also investigates the design of Industry 5.0 solutions and the need for problem-specific descriptions of production processes, operator skills and states, and sensor monitoring in intelligent spaces. The book proposes that ontology-based data can efficiently represent enterprise and manufacturing datasets. The book is divided into two parts: modeling and optimization. The semantic modeling part provides an overview of ontologies and knowledge graphs that can be used to create Industry 4.0 and 5.0 applications, with two detailed applications presented on a reproducible industrial case study. The optimization part of the book focuses on network science-based process optimization and presents various detailed applications, such as graph-based analytics, assembly line balancing, and community detection. The book is based on six key points: the need for horizontal and vertical integration in modern industry; the potential benefits of integrating semantic technologies into ERP and MES systems; the importance of optimization methods in Industry 4.0 and 5.0 concepts; the need to process large amounts of data while ensuring interoperability and re-usability factors; the potential for digital twin models to model smart factories, including big data access; and the need to integrate human factors in CPSs and provide adequate methods to facilitate collaboration and support shop floor workers.

SAP S/4HANA Supply Chain Planning and Manufacturing

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Author :
Publisher : BPB Publications
ISBN 13 : 9355516231
Total Pages : 529 pages
Book Rating : 4.3/5 (555 download)

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Book Synopsis SAP S/4HANA Supply Chain Planning and Manufacturing by : Dr. Ankush Agrawal

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

Recent Trends in Social and Behaviour Sciences

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Author :
Publisher : CRC Press
ISBN 13 : 1315775530
Total Pages : 100 pages
Book Rating : 4.3/5 (157 download)

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Book Synopsis Recent Trends in Social and Behaviour Sciences by : Ford Lumban Gaol

Download or read book Recent Trends in Social and Behaviour Sciences written by Ford Lumban Gaol and published by CRC Press. This book was released on 2014-02-27 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: The human aspect plays an important role in the social sciences. The behaviour of people has become a vital area of focus in the social sciences as well. Recent Trends in Social and Behaviour Sciences contains papers that were originally presented at the International Congress on Interdisciplinary Behavior and Social Sciences, held 4-5 November 201

Implementing a Curriculum for Improving Accuracy of Real-time Comments in Electronic Batch Records for Genentech, Inc

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (99 download)

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Book Synopsis Implementing a Curriculum for Improving Accuracy of Real-time Comments in Electronic Batch Records for Genentech, Inc by : Kirstie Hunt

Download or read book Implementing a Curriculum for Improving Accuracy of Real-time Comments in Electronic Batch Records for Genentech, Inc written by Kirstie Hunt and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Genentech is a biopharmaceutical company located in Oceanside, CA. The Oceanside campus is one of five locations within the United States and is a multi-product drug substance Manufacturing facility of biopharmaceuticals. The Manufacturing production plant is controlled by an automated system called DeltaV, which facilitates the processing equipment to effectively produce biopharmaceuticals. DeltaV has the ability to track any process recordable including: alarms, holds/restart, overrides, and process interventions; simultaneously recording them to an Electronic Batch Record (EBR). In addition to the automated control system, Manufacturing bioprocess technicians provide manual support and oversight for the process operations and equipment. There are a multitude of Standard Operating Procedures (SOP), work instructions, training modules, instructor-led courses and other tools that provide guidelines and information for employees to perform compliant operations. EBRs are official Good Manufacturing Practice (GMP) documents that provide an audit trail for all manufacturing processes. The EBR is segmented into different sections including: material usage, equipment usage, batch formula, procedure details, phase details, failure messages, alarms, and process interventions. The EBR is generated real-time while a process recipe is running in DeltaV and populates the information to the Manufacturing Execution System (MES) or Syncade. Completed EBRs are compiled into the MES queue and undergo Manufacturing Quality Assurance (MQA) review, Manufacturing review, MQA approval and then become archived once the process is complete. Each step within the review process is tedious and time consuming, requiring acquisition of relevant information and a high degree of patience and technical accuracy to ensure the job is done correctly. It is the responsibility of MQA to make note of any issues, inconsistencies, or missing components within the completed record. It is the responsibility of the Manufacturing Department to address MQA's instructions with an appropriate comment. This review process is prolonged if comments are not entered real-time, thus generating more time in the review process and extensive investigation. There are a number of EBRs that require rework, which adds complexity, time, and non-value to the operations, thus costing Genentech money by impacting lot disposition and ultimately patients receipt of medication in a timely manner. Genentech would like to codify a solution for technicians to compose right the first time comments that are written real-time and reduce the percentage of batch records that are not completed correctly. This project aims to successfully analyze and implement a resourceful solution to the issue at hand. The DMAIC approach was conducted in order to identify and analyze the contributing elements that pose a threat to right the first time batch records. The DMAIC model is comprised of the following components: Define, Measure, Analyze, Improve and Control. The DMAIC approach is highlighted as a core component to the Six Sigma methodology, which is widely used as an industry standard. Six Sigma is a disciplined methodology for eliminating defects in Genentech's manufacturing process. The utilization of this concept has allowed for a development and implementation of an instructor-led training curriculum titled Right the First Time Comments Training. The idea of incorporating an instructor-led training course stemmed from studies stating it was a more effective and engaging method of encoding the content to trainees. Reportedly, 70% of learning comes from on the job practice (Heathfield, 2016), thus guiding the instructor-led training course to incorporate a variety of real life simulations that engage the attention of the trainees. The objective of the training course is to teach technicians how to write batch comments that are right the first time in order to avoid mistakes that may cause unnecessary re-work and delays. Upon completion of this course technicians will be equipped to navigate through MES/Syncade and DeltaV, locate in-process batch records, utilize process historian, identify SOP linkages, and properly write a comment.

Practical Batch Process Management

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Author :
Publisher : Elsevier
ISBN 13 : 0080455433
Total Pages : 189 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Practical Batch Process Management by : Mike Barker

Download or read book Practical Batch Process Management written by Mike Barker and published by Elsevier. This book was released on 2004-11-18 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Historically batch control systems were designed individually to match a specific arrangement of plant equipment. They lacked the ability to convert to new products without having to modify the control systems, and did not lend themselves to integration with manufacturing management systems. Practical Batch Management Systems explains how to utilize the building blocks and arrange the structures of modern batch management systems to produce flexible schemes suitable for automated batch management, with the capability to be reconfigured to use the same plant equipment in different combinations. It introduces current best practice in the automation of batch processes, including the drive for integration with MES (Manufacturing Execution System) and ERP (Enterprise Resource Planning) products from major IT vendors. References and examples are drawn from DCS / PLC batch control products currently on the market. - Implement modern batch management systems that are flexible and easily reconfigured - Integrate batch management with other manufacturing systems including MES and ERP - Increase productivity through industry best practice

Cracking the SAP S/4HANA Interview

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Publisher : BPB Publications
ISBN 13 : 9355512198
Total Pages : 271 pages
Book Rating : 4.3/5 (555 download)

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Book Synopsis Cracking the SAP S/4HANA Interview by : Sudipta Malakar

Download or read book Cracking the SAP S/4HANA Interview written by Sudipta Malakar and published by BPB Publications. This book was released on 2022-04-14 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to achieve a highest level of SAP S/4 HANA, Central Finance and Group Reporting KEY FEATURES ● In-depth demonstration of SAP S/4HANA 2020, 1909, and 2021 fundamentals. ● Includes graphical illustrations for Migration Cockpit commands and methods. ● Hands-on practice on Fiori, BPC, SAP S/4 HANA Central Finance and Group reporting. DESCRIPTION This book will guide you through the process about what you need to know and help you perform at your highest level to achieve SAP S/4 HANA and some of the best practices available today. This book can assist you in acing employment interviews. This book provides an in-depth practical illustration of SAP S/4HANA 2020, 1909, and 2021 fundamentals with several examples. It contains graphical demonstrations and visual descriptions of the commands and methods available in the SAP S/4 HANA Migration Cockpit. It includes thorough hands-on practice showcasing Fiori, BPC, SAP S/4 HANA Central Finance, and Group reporting subjects using SAP S/4HANA standards. Many applications and industry-wide projects are included in the book. After reading this book, you will be able to reliably perform Basis, Security, SD, MM, PP, FICO, and HCM operations, as well as define complicated tasks in SAP S/4 HANA from the very first day. WHAT YOU WILL LEARN ● Perform Basis, Security, SD, MM, PP, FICO, and HCM processes in SAP S/4 HANA. ● Forecast and monitor progress throughout the SAP S/4HANA deployment process. ● Administration, implementation, and authorisation of SAP S/4 HANA systems from start to finish. ● Enterprise-wide backup, restore, and monitoring of SAP HANA databases. ● Leverage Fiori apps to carry out SAP S/4 HANA tasks. WHO THIS BOOK IS FOR This book is meant for S/4 HANA consultants and project managers as well as those working in other fields related to SAP S/4 HANA. If you read this book, you will be well-versed in every step of the SAP S/4HANA project development lifecycle. TABLE OF CONTENTS 1. SAP S/4 HANA 2020, 2021, 1909 Interview questions. 2. Lessons learnt and pragmatic approach – SAP S/4 HANA Interview questions. 3. SAP S/4 HANA Data Migration Interview questions. 4. Interview questions and answers on BPC, SAP S/4 HANA Central Finance and Group reporting.

Pharmaceutical Computer Systems Validation

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Author :
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Computer Systems Validation by : Guy Wingate

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.

Instrument Engineers' Handbook, Volume 3

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Author :
Publisher : CRC Press
ISBN 13 : 1351832980
Total Pages : 1142 pages
Book Rating : 4.3/5 (518 download)

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Book Synopsis Instrument Engineers' Handbook, Volume 3 by : Bela G. Liptak

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 1142 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.

Instrument Engineers' Handbook

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Author :
Publisher : CRC Press
ISBN 13 : 1439817766
Total Pages : 1142 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Instrument Engineers' Handbook by : Bela G. Liptak

Download or read book Instrument Engineers' Handbook written by Bela G. Liptak and published by CRC Press. This book was released on 2011-08-19 with total page 1142 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.

Sterile Processing of Pharmaceutical Products

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119802326
Total Pages : 372 pages
Book Rating : 4.1/5 (198 download)

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Book Synopsis Sterile Processing of Pharmaceutical Products by : Sam A. Hout

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.

Sterile Manufacturing

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Author :
Publisher : CRC Press
ISBN 13 : 1000406121
Total Pages : 148 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Sterile Manufacturing by : Sam A. Hout

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.

Biopharmaceutical Processing

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Author :
Publisher : Elsevier
ISBN 13 : 0128125527
Total Pages : 1310 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biopharmaceutical Processing by : Gunter Jagschies

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

Electronic Resource Management in Libraries: Research and Practice

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Author :
Publisher : IGI Global
ISBN 13 : 1599048922
Total Pages : 440 pages
Book Rating : 4.5/5 (99 download)

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Book Synopsis Electronic Resource Management in Libraries: Research and Practice by : Yu, Holly

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.

Manufacturing of Quality Oral Drug Products

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Author :
Publisher : CRC Press
ISBN 13 : 1000603423
Total Pages : 213 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Manufacturing of Quality Oral Drug Products by : Sam A. Hout

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.