Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook PDF Download
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Author: Jordi Botet
Publisher: Bentham Science Publishers
ISBN: 1681081148
Category : Medical
Languages : en
Pages : 504
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Book Description
Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.
Author: Jordi Botet
Publisher: Bentham Science Publishers
ISBN: 1681081148
Category : Medical
Languages : en
Pages : 504
Get Book Here
Book Description
Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.
Author: Jack Wong
Publisher: CRC Press
ISBN: 0429996764
Category : Medical
Languages : en
Pages : 475
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Book Description
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Author: Masahiko Minami
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 1501500805
Category : Language Arts & Disciplines
Languages : en
Pages : 615
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Book Description
Applied linguistics is the best single label to represent a wide range of contemporary research at the intersection of linguistics, anthropology, psychology, and sociology, to name a few. The Handbook of Japanese Applied Linguistics reflects crosscurrents in applied linguistics, an ever-developing branch/discipline of linguistics. The book is divided into seven sections, where each chapter discusses in depth the importance of particular topics, presenting not only new findings in Japanese, but also practical implications for other languages. Section 1 examines first language acquisition/development, whereas Section 2 covers issues related to second language acquisition/development and bilingualism/multilingualism. Section 3 presents problems associated with the teaching and learning of foreign languages. Section 4 undertakes questions in corpus/computational linguistics. Section 5 deals with clinical linguistics, and Section 6 takes up concerns in the area of translation/interpretation. Finally, Section 7 discusses Japanese sign language. Covering a wide range of current issues in an in an in-depth, comprehensive manner, the book will be useful for researchers as well as graduate students who are interested in Japanese linguistics in general, and applied linguistics in particular. Chapter titles Chapter 1. Cognitive Bases and Caregivers' Speech in Early Language Development (Tamiko Ogura, Tezukayama University) Chapter 2. Literacy Acquisition in Japanese Children (Etsuko Haryu, University of Tokyo) Chapter 3. Age Factors in Language Acquisition (Yuko Goto Butler, University of Pennsylvania) Chapter 4. Cross-lingual Transfer from L1 to L2 Among School-age Children (Kazuko Nakajima, University of Toronto) Chapter 5. Errors and Learning Strategies by Learners of Japanese as an L2 (Kumiko Sakoda, Hiroshima University/NINJAL) Chapter 6. Adult JFL Learners' Acquisition of Speech Style Shift (Haruko Minegishi Cook, University of Hawai'i at Manoa) Chapter 7. Japanese Language Proficiency Assessment (Noriko Kobayashi, Tsukuba University) Chapter 8. The Role of Instruction in Acquiring Japanese as a Second Language (Kaoru Koyanagi, Sophia University) Chapter 9. The Influence of Topic Choice on Narrative Proficiency by Learners of Japanese as a Foreign Language (Masahiko Minami, San Francisco State University) Chapter 10. CHILDES for Japanese: Corpora, Programs, and Perspectives (Susanne Miyata, Aichi Shukutoku University) Chapter 11. KY Corpus (Jae-Ho Lee, Tsukuba University) Chapter 12. Corpus-based Second Language Acquisition Research (Hiromi Ozeki, Reitaku University) Chapter 13. Assessment of Language Development in Children with Hearing Impairment and Language Disorders (Kiyoshi Otomo, Tokyo Gakugei University) Chapter 14. Speech and Language Acquisition in Japanese Children with Down Syndrome (Toru Watamaki, Nagasaki University) Chapter 15. Revisiting Autistic Language: Is "literalness" a Truth or Myth? Manabu Oi (Osaka University/Kanazawa University) Chapter 16. Towards a Robust, Genre-based Translation Model and its Application (Judy Noguchi, Mukogawa Women's University; Atsuko Misaki, Kwansei Gakuin University; Shoji Miyanaga, Ritsumeikan University; Masako Terui, Kinki University) Chapter 17. Japanese Sign Language: An Introduction (Daisuke Hara, Toyota Technological Institute) Chapter 18. Japanese Sign Language Phonology and Morphology (Daisuke Hara, Toyota Technological Institute) Chapter 19. Japanese Sign Language Syntax (Noriko Imazato, Kobe City College of Technology) Chapter 20. Sign Language Development and Language Input (Takashi Torigoe, Hyogo University of Teacher Education)
Author: Jack Wong
Publisher: CRC Press
ISBN: 1000440532
Category : Medical
Languages : en
Pages : 620
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Book Description
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Author: Atta-ur- Rahman
Publisher: Bentham Science Publishers
ISBN: 1681082136
Category : Medical
Languages : en
Pages : 253
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Book Description
Natural products continue to play a key role in drug development. A recent analysis of the drug market in the developed world revealed that 40% of total clinically approved drugs were either unmodified natural products or their semi-synthetic derivatives. This book series focuses on reviews of exciting new bioactive natural products that have huge potential as drugs. It highlights the everlasting importance of natural products in our lives. Each volume brings reviews contributed by eminent scientists in the field. The first volume covers the following topics: - bioactive compounds from marine invertebrates - natural product derived drugs for immunological and inflammatory diseases - clinical trials of curcumin, camptothecin, astaxanthin, and biochanin - antibacterial and antifungal drugs from natural sources - natural products as anti-HIV medicines.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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Book Description
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.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
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Book Description
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.
Author: Shayne Cox Gad
Publisher: Wiley-Interscience
ISBN: 9780470259597
Category : Science
Languages : en
Pages : 856
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Book Description
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.
Author: John Sharp
Publisher: CRC Press
ISBN: 9780367393779
Category :
Languages : en
Pages : 520
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Book Description
With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.
Author: Gottfried Schmalz
Publisher: Springer Science & Business Media
ISBN: 3540777822
Category : Medical
Languages : en
Pages : 392
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Book Description
This book provides a comprehensive and scientifically based overview of the biocompatibility of dental materials. Up-to-date concepts of biocompatibility assessment are presented, as well as information on almost all material groups used in daily dentistry practice. Furthermore, special topics of clinical relevance (e.g,, environmental and occupational hazards and the diagnosis of adverse effects) are covered. The book will: improve the reader’s ability to critically analyze information provided by manufacturers supply a better understanding of the biocompatibility of single material groups, which will help the reader choose the most appropriate materials for any given patient and thus prevent adverse effects from developing provide insights on how to conduct objective, matter-of-fact discussions with patients about the materials to be used in dental procedures advise readers, through the use of well-documented concepts, on how to treat patients who claim adverse effects from dental materials feature clinical photographs that will serve as a reference when analyzing clinical symptoms, such as oral mucosa reactions.
