Download or read book Pharmaceutical Supply Chain written by Fred A. Kuglin and published by CRC Press. This book was released on 2015-07-29 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical Supply Chain Security written by United States House of Representatives and published by . This book was released on 2020-01-15 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical supply chain security: hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, July 11, 2006.
Download or read book Pharmaceutical Supply Chain Security written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-26 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical supply chain security : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, July 11, 2006.
Download or read book Supply Chain Management in the Drug Industry written by Hedley Rees and published by John Wiley & Sons. This book was released on 2011-04-06 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical Supply Chain Security written by and published by . This book was released on 2013 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Drug Supply Chain Security Act Explained written by Dirk Rodgers and published by Createspace Independent Publishing Platform. This book was released on 2016-01-26 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Drug Supply Chain Security Act (DSCSA) was passed by Congress in the fall of 2013 and signed into law by President Barack Obama on November 27, 2013. The DSCSA was Title II of the Drug Quality and Security Act (DQSA). The law establishes new requirements that must be administered by the Food and Drug Administration (FDA). These requirements escalate over time from 2015 through 2023 in a series of stages. They include lot-based tracing of prescription pharmaceuticals from the manufacturer to the dispenser from 2015 through 2023 and serialization-based tracing after 2023. Drug manufacturers must apply unique identifiers on all prescription drug packages by November 2017 and repackagers, wholesale distributors and dispensers must begin to buy and sell products marked with those identifiers by November of 2018, 2019 and 2020 respectively. This book explains the DSCSA, section by section, so that drug manufacturers, repackagers, wholesale distributors, dispensers, contract partners (CMOs, CPOs, 3PLs), solution providers, consultants, law firms, regulators and students can understand the text, the meaning and the significance of the law. The book also includes more than two dozen of the most informative RxTrace essays about various aspects of the DSCSA. These essays, by Dirk Rodgers, help to expose the implications of the law and provide the context necessary to understand its full impact on companies in the supply chain. In these essays, the latest FDA guidance related to the DSCSA, as of book publication, are explained. Praise for The Drug Supply Chain Security Act Explained, Second Edition: "Dirk Rodgers has an unparalleled knowledge of federal track and trace legislation. This book is essential reading for anyone who wants to understand and benefit from coming changes to the pharmaceutical supply chain." -- Adam J. Fein, Ph.D., president, Pembroke Consulting, Inc., and CEO, Drug Channels Institute "Through RxTrace, Dirk Rodgers has provided stakeholders valuable insights on DSCSA. As DSCSA has evolved, his questions and opinions have helped all the stakeholders understand compliance. Dirk's new book brings years of wisdom from RxTrace and more together in one volume." -- Napoleon Monroe, Managing Director, New Directions Technology Consulting, LLC "As dispensers entrusted with the last encounter for patient safety, it is important to have a venue for discussion on DSCSA implementation challenges amongst trading partners. In this book, Dirk provides his experience as a resource for companies to use to create solutions." -- Chris Chandler, PharmD, VP of USDM Healthcare
Download or read book Supply Chain in the Pharmaceutical Industry written by Rob Whewell and published by CRC Press. This book was released on 2016-04-01 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical and healthcare industry is hugely complex because it involves so many markets, products, processes and intermediaries. It is also heavily regulated, global, and used by everyone at some stage in their life. No wonder the supply chain for delivery of healthcare services is often fragmented and understood only in discrete sections. Changes in one area impact upon the others, and environmental factors such as pricing, regulatory change or actions by competitors impact the whole supply chain in ways that are not easily understood or managed. Accelerating technology, the commoditization of healthcare, increasing demands from ageing populations all influence the approach that suppliers of pharmaceutical products and services worldwide need to take if they are to design and manage an effective supply chain that will be capable of: exploiting their intellectual property in a sustainable way; providing safe and continuous provision of drugs or devices; and sustaining with resilience, yet still be flexible and cost efficient. Supply Chain in the Pharmaceutical Industry offers the basis for organizations to develop their own blueprint for managing the opportunities and threats to the pharmaceutical supply chain. Using examples from companies and markets across the world Rob Whewell offers a very vivid picture of the developing trends for pharmaceutical companies; the customers and markets they serve and points to some of the elements that underpin sustainable pharmaceutical strategies. The current global banking and financial crisis illustrates the important role played by regulation. The healthcare industry is similar in scope, and complexity, yet the implications of error are worse - life threatening. This review of key industry parameters will provide senior executives in the industry and policy makers in healthcare with a broad perspective of the issues and illustrates an understanding of the task at hand.
Download or read book Pharmaceutical Supply Chain Security written by United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources and published by . This book was released on 2007 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Securing the Pharmaceutical Supply Chain written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2014 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Supply Chain Transparency in the Pharmaceutical Returns Industry written by Anna Yankanich and published by . This book was released on 2024 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Company X, a pharmaceutical manufacturer, is seeking clarity on best practices for complying with the Drug Supply Chain Security Act (DSCSA). Additionally, they are looking to reevaluate current relationships with reverse distributor third-party logistics partners, as well as explore new entrants to the market. This thesis provides insight as to what two competitors are doing to meet compliance. It also includes a Strengths, Weaknesses, Opportunities, Threats (S.W.O.T.) Analysis of current RD 3PL partners, and compares the strengths and weaknesses of four additional entities. The methodology of thesis consists of reviewing publicly available sources, as well as expertise from representatives of Company X. The publicly available sources are found primarily through keyword searches, as well as reviewing online supply chain journals. Competitor practices and the RD 3PL S.W.O.T. analysis indicated that to stay competitive in the industry, investment in technological development is necessary. The information collected is intended to give Company X a broader view of the pharmaceutical returns industry, and assist them in creating a future request for proposal (RFP).
Download or read book Securing the Pharmaceutical Supply Chain written by Lenora White and published by Nova Science Publishers. This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The drug package that a community pharmacist hands to a patient, or a hospital pharmacist sends to a patient's bedside, or a physician administers in the medical office has reached the end of a complicated path. That path is called a supply or distribution chain. The upstream portion of the chain includes the journey of each active and inactive ingredient and their chemical components to the manufacturer that creates the finished drug product. The downstream chain, which this report addresses, includes the repackagers, wholesale distributors, associated storage and transport companies, and, finally, the dispenser. Dispensers include independent community or chain pharmacies, hospitals or other health care facilities, and physicians' offices. Usually the supply chain provides consumers with unadulterated prescription drugs. However, the chain is potentially vulnerable, and when it breaks, a dispenser might provide a counterfeit product containing no active ingredient, less-than-labelled dosage, or a dangerous substitution. The dispenser might also provide a mishandled or diverted drug that has become sub- or superpotent or has gone past its expiration Usually the supply chain provides consumers with unadulterated prescription drugs. However, the chain is potentially vulnerable, and when it breaks, a dispenser might provide a counterfeit product containing no active ingredient, less-than-labelled dosage, or a dangerous substitution. The dispenser might also provide a mishandled or diverted drug that has become sub- or superpotent or has gone past its expiration. This book serves as a primer on pharmaceutical supply chain issues. It describes the chain from manufacturer13 to patient, including where it is vulnerable; summarises current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drug product, and indicates where those protections may falter; notes state-level and professional association activities; and discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Download or read book Impact of Drug Supply Chain Security Act on US Pharmaceutical Industry Under Decentralized Information Flow written by Meng Ying Chang (M. Eng.) and published by . This book was released on 2017 with total page 47 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug counterfeiting is one of the major issues in the pharmaceutical industry across the world. These products could cause damages from ineffective treatments to death of patients. In order to fight against counterfeit drugs, the US government introduced Drug Supply Chain Security Act (DSCSA) mandating that all prescription drugs should be serialized. In addition, it mandates all pharmaceutical companies in the U.S. to provide tracking documents in response to a tracing request from FDA. While the act aims to improve drug security across the pharmaceutical industry, it poses a huge impact across the supply chain on both physical flow and information flow. This research evaluates the supply chain impact at an industry level. In this thesis, we evaluate the supply chain impact of Matryoshka model and Unit level model supported by a decentralized information flow. The thesis then evaluates the supply chain impact from three aspects, operational cost, IT infrastructure cost and capital investment. We reference Nabiyeva and Wu's research on centralized information flow model to conduct an exhaustive supply chain impact evaluation across the centralized model and the decentralized model. We conclude that among all these scenarios, unit level model under centralized information flow design bears the highest cost as it requires higher IT investment. On the other hand, the matryoshka model under decentralized information flow has a least supply chain impact from the cost perspective with low IT investment.
Download or read book Pharmaceutical Supply Chain Security Serial No 109 227 July 11 2006 109 2 Hearing written by United States. Congress. House. Committee on Government Reform and published by . This book was released on 2007* with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Framework to Evaluate Interoperable Data Exchange Models for Drug Supply Chain Security Act Compliance written by Peter Wontae Chung and published by . This book was released on 2016 with total page 50 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States has one of the safest drug supply chains in the world. However, its security is threatened by new challenges such as counterfeit, diverted, and illegally imported drugs. To counter the new challenges, the Drug Supply Chain Security Act (DSCSA) was signed into law by President Obama on November 27, 2013, with a 10-year implementation timeframe. As a result, companies in the U.S. pharmaceutical industry, including drug manufacturers, distributors, and dispensers, are challenged to fully comply with the DSCSA by 2023. The compliance with the DSCSA will enable companies to operate and manage the risks of their supply chains more efficiently. Industry consortiums, such as the Healthcare Distribution Management Association (HDMA), and the industry leaders have recommended various interoperable data exchange models for the implementation of the compliance. However, domestic and international complexities make it difficult to pick the optimal model for the industry. In this research, we start with categorizing the known data exchange models that can be potentially used by the U.S. pharmaceutical industry. Second, we develop a scorecard methodology based on a framework that considers various factors across the entire supply chain. Next, we examine the categorized models using this scorecard methodology. Lastly, we conclude with recommendations on the data strategy decision for the U.S. pharmaceutical industry.
Download or read book Pharmaceutical Supply Chain Security Scholar s Choice Edition written by United States Congress House of Represen and published by . This book was released on 2015-02-14 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work.As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Download or read book Drug Supply Chain Security Act of 2013 and Its Computer System Implementation written by Daryl O. Jones and published by . This book was released on 2014 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Since 1987, the federal government and later, the state governments, have tried to combat counterfeit drugs from entering the United States and the state's pharmaceutical supply chain. The latest attempt to prevent counterfeit drugs from entering the state drug supply chain was the California E-Pedigree drug tracing program that was to be implemented by the end of 2017. The California E-Pedigree system uses GS1 PDMS tracing system as its guideline. Since all of the states use paper format pedigree systems, California would have been the first electronic pedigree system in the U.S. However, on November 27, 2013, the President of the United States signed into law the Drug Quality Security Act (DQSA). Title II of DQSA is called Drug Supply Chain Security Act (DSCSA) and it removes all existing or future drug track or trace systems including pedigree systems from all states. DSCSA does establish a new federal drug tracing program that uses pedigrees and product identifiers for verification of the drugs being accepted by the buyer. Although the full implementation of the DSCSA will take about ten years from its enactment, the basic structure of the new federal tracing program is laid out. My thesis will analyze the current state of the pharmaceutical industry, the impact from counterfeit medicine, and anti-counterfeit technologies. We will proceed to analyze the DSCSA to create a basic logical model and show a possible implementation of its verification process. Additionally, we will discuss DSCSA model as to its effectiveness of the basic design against the entrance of counterfeit medicine into the United States Pharmaceutical Supply Chain. This will be followed by a conclusion"--Leaf iv.
Download or read book Global Supply Chains in the Pharmaceutical Industry written by Nozari, Hamed and published by IGI Global. This book was released on 2018-11-09 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
