Download or read book International Biotechnology Bulk Chemical and Pharmaceutical GMPs Fifth Edition written by Michael H. Anisfeld and published by CRC Press. This book was released on 1999-05-31 with total page 716 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains the English language texts of all GMPs (regulations, guidelines, codes, and practices) implemented by national and international regulatory authorities that govern the manufacture and testing of biotechnology-derived products, active pharmaceutical ingredients, and pharmaceuticals. Prepared with the cooperation of health authorities worldwide, this resource contains the GMPs in effect in 114 countries, plus GMP regulations of the World Health Organization (including the 1996 WHO GMPs), the European Union, the Association of South East Asian Nations, and the Pharmaceutical Inspection Convention.
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 Fundamentals of Modern Bioprocessing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2017-07-27 with total page 746 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing—the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.
Download or read book Forthcoming Books written by Rose Arny and published by . This book was released on 2001-06 with total page 1736 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 Subject Guide to Books in Print written by and published by . This book was released on 1997 with total page 3310 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Biotechnology written by Daan J. A. Crommelin and published by CRC Press. This book was released on 2002-11-14 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.
Download or read book Enhancing the Regulatory Decision Making Approval Process for Direct Food Ingredient Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1999-04-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 1999-01-31 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.
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 Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2004-04-27 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul
Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 674 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Download or read book Books in Print Supplement written by and published by . This book was released on 2002 with total page 2576 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
Download or read book Textbook of Pharmaceutical Biotechnology written by Chandrakant Kokate and published by Elsevier Health Sciences. This book was released on 2012-05-14 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: Textbook of Pharmaceutical Biotechnology
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:
