Download or read book Contract Manufacturing of Medicines written by Magdalena Krekora and published by Kluwer Law International B.V.. This book was released on 2008-01-01 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and definition of andmedicineand in different jurisdictions; and categories of medicines; and manufacturing and importation regulation in numerous jurisdictions worldwide; and inspection regimes; and good manufacturing practice (GMP); and marketing authorization; and manufacturing documentation; and complaints and product recall; and liability insurance; and protection of trade secrets; and data exclusivity and data protection; and deficiencies and delays; and and recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.
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.
Download or read book Legal aspects of outsourcing contracts in the pharmaceutical industry A practical guide written by and published by Pharmalicensing. This book was released on with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Strategies Used by Adults to Reduce Their Prescription Drug Costs written by Robin A. Cohen and published by . This book was released on 2015 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Art of Pharmaceutical Manufacturing written by G.C. Hanford Manufacturing Company (Syracuse, N.Y.) and published by . This book was released on 1994 with total page 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 2008-03-21 with total page 1384 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 Pharmaceutical Outsourcing Discovery and Preclinical Services written by William C. Stevens Jr. and published by Lulu.com. This book was released on 2011 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!
Download or read book Manufacturing of Pharmaceutical Proteins written by Stefan Behme and published by John Wiley & Sons. This book was released on 2015-03-20 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Contract Research and Manufacturing Services CRAMS in India written by Milind Antani and published by Elsevier. This book was released on 2012-10-31 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. Simple and accessible presentation using tables, charts and diagrams Practical tips from leading practitioners Inclusion of relevant case laws and other legal considerations
Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
Download or read book Good Manufacturing Practices GMP Modules for Pharmaceutical Products written by Chandrasekhar Panda and published by . This book was released on 2021-07-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book contains 11 Modules of Good Manufacturing Practices (GMP) for Pharmaceutical Products which will be very useful to the persons working in Pharmaceutical Industry and this can be used as a cGMP Training modules in Pharmaceutical Companies which is a basic training requirement for every employee. The Modules are Module-1 Plant Premises Module-2 Plant Equipment's Module-3 Plant Production Module-4 Plant Personnel Module-5 Plant Training, Documentation and Personnel Hygiene Module-6 Plant Quality Control Module-7 Qualification and Validation Module-8 Pharmaceutical QMS Module-9 Plant Self-Inspection and Audit Module-10 Plant Complaints and Product recall Module-11 Plant Contract Manufacturing and Contract Analysis
Download or read book Key Players in Pharmaceutical Contract Manufacturing written by and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical contract manufacturing industry continues to grow, driven by mounting industry pressures. The highly competitive nature of the industry has been driving consolidation and companies are increasingly offshoring to emerging markets.
Download or read book Contract Pharmaceutical Manufacturing Research and Packaging written by BCC Research and published by . This book was released on 2009-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drugs Pharmaceutical Technology Handbook written by NIIR Board and published by ASIA PACIFIC BUSINESS PRESS Inc.. This book was released on 2004-01-01 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drugs and pharmaceutical industry plays a vital role in the economic development of a nation. It is one of the largest and most advanced sectors in the world, acting as a source for various drugs, medicines and their intermediates as well as other pharmaceutical formulations. India has come a long way in this field, from a country importing more than 95% of its requirement of drugs and pharmaceuticals; India now is exporting it even to developed countries. Being the intense knowledge driven industry, it offers innumerable business opportunities for the investors/ corporate the world over. The existence of well defined and strong pharmaceutical industry is important for promoting and sustaining research and developmental efforts and initiatives in an economy as well as making available the quality medicines to all at affordable prices. That is, it is essential to improve the health status of the individuals as well as the society as a whole, so that positive contributions could be made to the economic growth and regional development of a country. On the global platform, India holds fourth position in terms of volume and thirteenth position in terms of value of production in pharmaceuticals. The pharmaceutical industry has been producing bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing processes as well as a wide range of pharmaceutical machinery and equipments. The modern Indian Pharmaceutical Industry is recent and its foundation was laid in the beginning of the current century. The pharmaceutical industry can be broadly categorised as bulk drugs, formulations, IV fluids and pharmaceutical aids (such as medical equipment, hospital disposables, capsules, etc.). Special feature of the pharmaceutical industry is a large number of manufacturers in the small scale sector. The government is also encouraging the SSI sector providing some incentives. The recent developments in the technology and R & D work in this field have led to the increased growth rate of industries and have established Indian Pharmaceutical industries in the international market. The content of the book includes information about properties, general methods of analysis, methods of manufacture, of different types of drugs and pharmaceuticals. Some of the fundamentals of the book are polymeric materials used in drug delivery systems , theoretical aspects of friction and lubrication , a convenient method for conversion of quinine to quinidine, formulation and evaluation of bio-available enteric-coated erythromycin and metronidazole tablets, extraction of virginiamycin, antipyretics and analgesics, column chromatographic assay of aspirin tablets, differentiating titration of phenacetin and caffeine, infrared spectra of some compounds of pharmaceutical interest etc. This book covers an intensive study on manufacturing, production, formulation and quality control of drugs and pharmaceuticals with technology involved in it. This book is an invaluable resource for technologists, professionals and those who want to venture in this field. 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Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Download or read book Contract Pharmaceutical Manufacturing Research and Packaging written by BCC Research and published by . This book was released on 2011-09 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
