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Author: Fred A. Kuglin
Publisher: CRC Press
ISBN: 1482258943
Category : Business & Economics
Languages : en
Pages : 204
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Book Description
Error-proofing in the production process of pharmaceuticals isn‘t just a matter of good business, it has life-and-death implications for consumers. The 2013 Drug Quality and Security Act introduces more stringent compliance factors towards this common goal, in large part requiring new mandates on tracking and tracing chain of custody in the supply chain. This book comprehensively overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.
Author: Fred A. Kuglin
Publisher: CRC Press
ISBN: 1482258943
Category : Business & Economics
Languages : en
Pages : 204
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Book Description
Error-proofing in the production process of pharmaceuticals isn‘t just a matter of good business, it has life-and-death implications for consumers. The 2013 Drug Quality and Security Act introduces more stringent compliance factors towards this common goal, in large part requiring new mandates on tracking and tracing chain of custody in the supply chain. This book comprehensively overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.
Author: Monika Mangla
Publisher: John Wiley & Sons
ISBN: 1119769302
Category : Computers
Languages : en
Pages : 386
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Book Description
The book aims to integrate the aspects of IoT, Cloud computing and data analytics from diversified perspectives. The book also plans to discuss the recent research trends and advanced topics in the field which will be of interest to academicians and researchers working in this area. Thus, the book intends to help its readers to understand and explore the spectrum of applications of IoT, cloud computing and data analytics. Here, it is also worth mentioning that the book is believed to draw attention on the applications of said technology in various disciplines in order to obtain enhanced understanding of the readers. Also, this book focuses on the researches and challenges in the domain of IoT, Cloud computing and Data analytics from perspectives of various stakeholders.
Author: Ravendra Singh
Publisher: Elsevier
ISBN: 0444639667
Category : Technology & Engineering
Languages : en
Pages : 700
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Book Description
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
Author: Hedley Rees
Publisher: John Wiley & Sons
ISBN: 0470922842
Category : Medical
Languages : en
Pages : 458
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Book Description
This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 96
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Book Description
Author: Roger Bate
Publisher: AEI Press
ISBN: 0844772348
Category : Business & Economics
Languages : en
Pages : 489
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Book Description
Roger Bate has spend years on the trail of counterfeit medicines in Asia, Africa, and the Middle East, learning the anatomy of a nebulous, far-reaching black market that has resulted in countless deaths and injuries around the world. Phake: The Deadly World of Falsified and Substandard Medicines is the culmination of Bate's research and travels—both a fascinating first hand account of the counterfeit drug trade and an incisive policy analysis with important ramifications for decision makers in the U.S. Food and Drug Administration and the international World Health Organization.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
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Book Description
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author: Dan Burges
Publisher: Butterworth-Heinemann
ISBN: 012391468X
Category : Social Science
Languages : en
Pages : 391
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Book Description
Cargo Theft, Loss Prevention, and Supply Chain Security outlines steps for identifying the weakest links in the supply chain and customizing a security program to help you prevent thefts and recover losses. Written by one of the world’s leading experts in cargo theft analysis, risk assessment and supply chain security, this is the most comprehensive book available on the topic of cargo theft and loss prevention. Part history of cargo theft, part analysis and part how-to guide, the book is the one source supply chain professionals and students can turn to in order to understand every facet of cargo theft and take steps to prevent losses.This groundbreaking book contains methods of predictive cargo theft modeling, allowing proactive professionals to develop prevention solutions at every step along the supply chain. It provides a complete methodology for use in creating your own customized supply chain security program as well as in-depth analysis of commonly encountered supply chain security problems. It also supplies a massive amount of credible cargo theft statistics and provides solutions and best practices to supply chain professionals who must determine their company’s risk and mitigate their losses by adopting customizable security programs. Furthermore, it presents cutting-edge techniques that industry professionals can use to prevent losses and keep their cargo secure at every stage along the supply chain.This book will be of interest to manufacturing, logistics and security professionals including chief security officers, VPs of logistics or supply chain operations, and transportation managers, as well as professionals in any company that manufactures, ships, transports, stores, distributes, secures or is otherwise responsible for bulk product and cargo. Outlines steps you can take to identify the weakest links in the supply chain and customize a security program to help you prevent thefts and recover losses Offers detailed explanations of downstream costs in a way that makes sense - including efficiency losses, customer dissatisfaction, product recalls and more - that dramatically inflate the impact of cargo theft incidents Provides a complete methodology for use in creating your own customized supply chain security program as well as in-depth analysis of commonly encountered supply chain security problems
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030922408X
Category : Medical
Languages : en
Pages : 366
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Book Description
A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Author: Valentina Emilia Balas
Publisher: Academic Press
ISBN: 0128213264
Category : Medical
Languages : en
Pages : 382
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Book Description
An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing.This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance.
