Download or read book The Business of Pharmaceutical Inspection written by Convention for the Mutual Recognition of Inspection in Respect of the Manufacture of Pharmaceutical Products Cambridge, England) and published by . This book was released on 1987 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a new postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book Corporate Crime in the Pharmaceutical Industry Routledge Revivals written by John Braithwaite and published by Routledge. This book was released on 2013-10-08 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
Download or read book Government Big Pharma and The People written by Mickey C. Smith and published by CRC Press. This book was released on 2020-12-02 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals constitute a relatively small share of the total Health Care expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford Health Care. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, and support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall Health Care system. The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, its contribution to Health and Health Care, and its dual and often conflicting priorities of affordability and innovation, as well as the various Private and Public Policy initiatives directed at the sector. Everyone is affected by Big Pharma and the products they produce. At the Drug store, the physician’s office, in front of the television, in everyday conversations, Drugs are a part of our lives. Society shapes our values toward Drugs and Drugs shape society. ("The Pill" and minor tranquilizers are good examples.) And, of course, the way Congress deliberates and Big Pharma responds has a huge impact on how Drugs affect our lives. This book is well-researched on the subject of the pharmaceutical industry, its struggles with Government, and its relationship to the consumer from the early twentieth century until the present. The Dynamic Tension between the three participants – Government, Big Pharma, and the People – is described and explained to lead to an understanding of the controversies that rage today. The author describes how the Government, its many investigatory efforts, and the ultimate legislative results affect the industry and the consequences of their activities are explored in light of their effects on other players, including the patients and consumers who rely on both Government and Big Pharma for their well-being and who find sometimes unexpected consequences while giving special attention to the attitudes, beliefs, and misadventures of less-than-optimal Drug use. Stakeholders are identified with physicians as a major focus, as well as describing the significance of prescriptions as social objects and the processes by which physicians make choices on behalf of their patients. The author ties it all together with how Big Pharma affects and is affected by each of these groups. The author utilizes his 50-plus years’ experience as an academic, practicing pharmacist, and Big Pharma employee to describe the scope of the pharmaceutical industry and how it affects us on a daily basis, concluding with an inside look at Big Pharma and how regulations, marketing, and the press have affected their business, both good and bad.
Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Download or read book Good Manufacturing Practices for Pharmaceuticals Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The International Pharmacopoeia written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 1526 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Download or read book Knowledge Management in the Pharmaceutical Industry written by Elisabeth Goodman and published by Routledge. This book was released on 2016-04-22 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pharmaceutical Industry has been undergoing a major transformation since the heady days of 'big pharma' in the 1970s and 80s. Patent expiry, the rise of generics, and the decline of the blockbuster drug have all changed the landscape over the last 10-15 years. It's an environment where products can take 10 years or more to come to market, billions are spent on research and development, jobs are being shed in the western pharma homelands and regulators and the public are more demanding than ever. So what part is Knowledge Management playing and going to play in this vital international industry? Knowledge Management (KM) has many facets from providing comprehensive knowledge bases for workers, through the sharing of advice and problem solving, to providing an environment for innovation and change. This book, focusing on research and development, and manufacturing-based companies, explores how a range of techniques and approaches have been applied in the unique environment of the Pharmaceutical Industry, and examine how it can help the industry in the 21st century. Whilst the book is centered on the Pharmaceutical Industry, its objective will be to discuss and demonstrate how Knowledge Management can be applied in a variety of environments, and with a range of cultural issues. KM practitioners, and potential practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from both the examples of good practice and the lessons learned by the authors and contributors.
Download or read book FDA Foreign Drug Inspection Program written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2008 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Download or read book Inventing Disease and Pushing Pills written by Jörg Blech and published by Taylor & Francis. This book was released on 2023-05-09 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a highly accessible and reassuring account of how the pharmaceutical industry is redefining health, making it a state that is almost impossible to achieve. Many normal life processes – states as natural as birth, ageing, sexuality, unhappiness and death – are systematically being reinterpreted as pathological so creating new markets for their treatments. In this enlightening book, Jörg Blech reveals: how the invention of diseases by pharmaceutical companies is turning us all into patients, and how we can protect ourselves against this how the medical profession has been bullied and co-opted into endorsing profitable cures for people who aren't ill fears about how pharmaceutical companies create markets by playing on the general public's concern with their health A self-help book in the truest sense, Inventing Disease and Pushing Pills reassures us about our own health. It is essential reading for doctors, nurses and patients alike.
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
