Error-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act 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. The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will need to respond to the myriad of threats facing the pharmaceutical drug supply chain and comply with this act. He goes in depth into each segment of the pharmaceutical drug supply chain, describing the industry segment and how it will need to adapt to the new act. By incorporating real-world examples of industry leaders, the book underlines the contributions of individuals who have made a difference through innovations and execution. It also addresses how laws are made, and specifically how the Drug Quality and Security Act was passed by Congress and signed into law. In an industry that is so big, you may feel that you cannot make a difference. This book provides you with key insights on how the forward supply chain process should work and how anyone can make a difference at all levels.

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

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.

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.

Originally published in 1999 The Commercial Use of Biodiversity examines how biodiversity and the genetic material it contains are now as valuable resources. Access to genetic resources and their commercial development involve a wide range of parties such as conservation and research institutes, local communities, government agencies and companies. Equitable partnerships are not only crucial to conservation and economic development but are also in the interests of business and often required by law. In this authoritative and comprehensive volume, the authors explain the provisions of the Convention on Biological Diversity on access and benefit-sharing, the effect of national laws to implement these, and aspects of typical contracts for the transfer of materials. They provide a unique sector-by-sector analysis of how genetic resources are used, the scientific, technological and regulatory trends and the different markets in Pharmaceuticals, Botanical Medicines, Crop Development, Horticulture, Crop Protection, Biotechnology (in fields other than healthcare and agriculture) and Personal Care and Cosmetics Products. This will be an essential sourcebook for all those in the commercial chain, from raw material collection to product discovery, development and marketing, for governments and policy-makers drafting laws on access and for all the institutions, communities and individuals involved in the conservation, use, study and commercialisation of genetic resources.

* provides an in-depth discussion of recent advances in sterilization * identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions * explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results * New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

Medicinal chemistry and pharmacology are closely associated fields, and the use of natural products for their medicinal properties is ever-growing. The study of drugs from natural products and their effects on the living body are explored in this volume. The book looks into the research, discovery, and characterization of chemicals that exhibit biological effects. Providing an informative compilation of research, valuable case studies, and reviews of existing literature in the area, the book focuses on the ethnobotanical uses of natural products and phytochemicals for health care, including applications for diabetes, ulcers, wound healing, chronic alcoholism, hemorrhoidal treatment, cancer mitigation, pain management, immunotherapy, and more.

There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.

Drawing on anthropology, historical sociology and social-epidemiology, this multidisciplinary book investigates how pharmaceuticals are produced, distributed, prescribed, (and) consumed, and regulated in order to construct a comprehensive understanding of the issues that drive (medicine) pharmaceutical markets in the Global South today. Based on primary research conducted in Benin and Ghana, and additional data collected in Cambodia and the Ivory Coast, this volume uses artemisinin-based combination therapies (ACTs) against malaria as a central case study. It highlights the influence of the countries colonial and post-colonial history on their models for state regulation, production, and distribution, explores the determining role transnational actors as well as industries from the North but also and increasingly from the South play in influencing local pharmaceutical markets and looks at the behaviour of health care professionals and individuals. Stepping back, the authors then unpick the pharmaceuticalization process and the multiple regulations at stake by looking at the workings of, and linkages between, (biomedical health) pharmaceutical systems, (representatives of companies) industries, actors in private distribution, and consumer practices. Providing a thorough comparative analysis of the advantages and disadvantages of different pharmaceutical systems, it is an important contribution to the literature on pharmaceutalization and the governance of medication. It is of interest to students, researchers and policy-makers interested in medical anthropology, the sociology of health and illness, global health, healthcare management and pharmacy. The Open Access version of this book, available at http://www.taylorfrancis.com/books/9780429329517, has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license.

Compaction of powder constituents-both active ingredient and excipients-is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application. This unique reference covers: The physical structure of pharmaceutical compacts Bonding phenomena that occur during powder compaction Compression mechanisms of pharmaceutical particles Theories and basic principles of powder compaction New topics include: Compaction data analysis techniques The migration of powder constituents into commercial manufacture Instrumentation for compaction Compaction functionality testing, which is likely to become a USP requirement Design space for compaction Metrics required for scalability in tablet compression Interactive compaction and preformulation database for commonly used excipients

Advances and Challenges in Pharmaceutical Technology: Materials, Process Development and Drug Delivery Strategies examines recent advancements in pharmaceutical technology. The book discusses common formulation strategies, including the use of tools for statistical formulation optimization, Quality by design (QbD), process analytical technology, and the uses of various pharmaceutical biomaterials, including natural polymers, synthetic polymers, modified natural polymers, bioceramics, and other bioinorganics. In addition, the book covers rapid advancements in the field by providing a thorough understanding of pharmaceutical processes, formulation developments, explorations, and exploitation of various pharmaceutical biomaterials to formulate pharmaceutical dosage forms.

The study of pharmaceutical dosage forms has many connections to biological and medical sciences including physiology, biochemistry, pharmacology, pharmacotherapy, therapeutics, pharmacodynamics, pharmacokinetics, and pharmacognosy. Dictionary of Pharmaceutical Dosage Forms is a collection of terms and definitions prepared to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care. It can also provide reference material for hospital and medical staff, consultants, nursing instructors, and pharmaceutical science students. This first edition classifies and organizes the forms in an easily readable format, so readers will find it a quick and simple reference. Features Collects terms and definitions to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care Focuses on product dosage forms and includes supplementary information, providing readers, particularly pharmacy and medical students and professionals, insights into choices of dosage forms made during drug product development Offers information on the indications, contraindications, side effects, and more, for a given drug Classifies and organizes the forms in a readable format, providing a quick and simple reference

The pharmaceutical industry, long thought of as a recession-proof investment, now faces a day of reckoning. The reasons for this impending downfall are not hard to discern. The prices the industry charges for its prescription drugs have escalated at four to five times the cost-of-living increases during the past two decades and have reached a point where 30% of Americans must choose between filling a prescription, paying for housing, and buying food. This has brought about public pressure on governments around the world to control drug prices, yet the world's twenty largest pharma companies realized 80% of their growth as a result of exorbitant price hikes. Pharma currently enjoys its extraordinary profitability by exploiting the world's most vulnerable populations. Yet even their ability to increase prices in the face of falling demand does not satisfy their profit demands. The breadth and depth of pharma's marketing transgressions exceed those of any other industry and have now reached a point where authorities around the world have found it necessary to take legal action against its violations. Drastic change is needed if the pharmaceutical industry can equitably advance the health of the world's population and regain public esteem. This book illustrates the range and extent of pharma's violations and addresses the actions that should be implemented in order to make the drug industry a more constructive, less venal part of contemporary society. It will be of interest to researchers, academics, practitioners, and students with an interest in the pharmaceutical industry, healthcare management, regulation, and bioethics.

This book is open access under a CC-BY license. The importance of the pharmaceutical industry in Sub-Saharan Africa, its claim to policy priority, is rooted in the vast unmet health needs of the sub-continent. Making Medicines in Africa is a collective endeavour, by a group of contributors with a strong African and more broadly Southern presence, to find ways to link technological development, investment and industrial growth in pharmaceuticals to improve access to essential good quality medicines, as part of moving towards universal access to competent health care in Africa. The authors aim to shift the emphasis in international debate and initiatives towards sustained Africa-based and African-led initiatives to tackle this huge challenge. Without the technological, industrial, intellectual, organisational and research-related capabilities associated with competent pharmaceutical production, and without policies that pull the industrial sectors towards serving local health needs, the African sub-continent cannot generate the resources to tackle its populations' needs and demands. Research for this book has been selected as one of the 20 best examples of the impact of UK research on development. See http://www.ukcds.org.uk/the-global-impact-of-uk-research for further details.

Drug Delivery Aspects reviews additional features of drug delivery systems, along with the standard formulation development, like preclinical testing, conversion into solid dosage forms, roles of excipients and polymers used on stability and sterile processing. There is a focus on formulation engineering and related large scale (GMP) manufacturing, regulatory, and functional aspects of drug delivery systems. A detailed discussion on biologics and vaccines gives insights to readers on new developments in this direction. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems.

"This fascinating and most timely critical medical anthropology study successfully binds two still emergent areas of contemporary anthropological research in the global world: the nature and significant impact of multinational pharmaceutical manufacturers on human social life everywhere, and the contribution of corporations to the fast-paced degradation of our life support system, planet Earth. . . . Focusing on a pharmaceutically-impacted town on the colonized island of Puerto Rico, Dietrich ably demonstrates the value of ethnography carried out in small places in framing the large issues facing humanity." -Merrill Singer, University of Connecticut The production of pharmaceuticals is among the most profitable industries on the planet. Drug companies produce chemical substances that can save, extend, or substantially improve the quality of human life.However, even as the companies present themselves publicly as health and environmental stewards, their factories are a significant source of air and water pollution--toxic to people and the environment. In Puerto Rico, the pharmaceutical industry is the backbone of the island's economy: in one small town alone, there are over a dozen drug factories representing five multinationals, the highest concentration per capita of such factories in the world. It is a place where the enforcement of environmental regulations and the public trust they ensure are often violated in the name of economic development. The Drug Company Next Door unites the concerns of critical medical anthropology with those of political ecology, investigating the multi-faceted role of pharmaceutical corporations as polluters, economic providers, and social actors. Rather than simply demonizing the drug companies, the volume explores the dynamics involved in their interactions with the local community and discusses the strategies used by both individuals and community groups to deal with the consequences of pollution. The Drug Company Next Door puts a human face on a growing set of problems for communities around the world. Accessible and engaging, the book encourages readers to think critically about the role of corporations in everyday life, health, and culture.

Drug Delivery Trends examines a drift in the pharmaceutical field across the wide range of dosage forms, drug delivery systems (micro and nanoparticulate), at the regulatory front and on new types of therapies in the market. This volume additionally covers the challenges on drug delivery systems in terms of preclinical and current ways of determining quality and the options to solve the challenges associated with this. Most small-medium scale industries and academics struggle with initial regulatory challenges so a detailed discussion on regulatory trend covers the necessary basic understanding of regulatory procedures and provides the required guidance. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems.

This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.

Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems. Recognized international experts discuss the bioequivalence of dermatological and transdermal dosage forms. They explore the biochemistry and treatment of skin diseases, the structure and function of the skin, adverse dermal responses to drug formulations, mechanisms of drug transport through barrier membranes, and methods for measuring and modulating percutaneous permeation.

Emergence of Pharmaceutical Industry Growth with Industrial IoT Approach uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches, create efficiencies 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. Pharmaceutical manufacturing companies are no exception to this, as IoT has the potential to revolutionize aspects of the pharmaceutical manufacturing process, from drug discovery to manufacturing. Using clear, concise 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 of topics presented offers readers multiple perspectives on a how to integrate the Internet of Things into pharmaceutical manufacturing.

Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic changes in approaches for identifying new chemical entities with a desired biological activity. While chemical modification of existing leads was the most important approach in the 1970s and 1980s, high-throughput screening and structure-based design are now major players among a multitude of methods used in drug discov ery. Quite often, companies favor one of these relatively new approaches over the other, e.g., screening over rational design, or vice versa, but we believe that an intelligent and concerted use of several or all methods currently available to drug discovery will be more successful in the medium term. What has changed most significantly in the past few years is the time available for identifying new chemical entities. Because of the high costs of drug discovery projects, pressure for maximum success in the shortest possible time is higher than ever. In addition, the multidisciplinary character of the field is much more pronounced today than it used to be. As a consequence, researchers and project managers in the pharmaceutical industry should have a solid knowledge of the more important methods available to drug discovery, because it is the rapidly and intelligently combined use of these which will determine the success or failure of preclinical projects.