Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook PDF full book. Access full book title Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook by Jordi Botet. Download full books in PDF and EPUB format.
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: 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: Luis H. Reyes
Publisher: Elsevier
ISBN: 0443153949
Category : Science
Languages : en
Pages : 440
Get Book Here
Book Description
Antimicrobial Peptides: A Roadmap for Accelerating Discovery and Development covers the most important efforts of scientists and engineers worldwide to accelerate the process of discovery, production, and eventual market penetration of more potent antimicrobial peptides. These efforts have been fueled by emerging technologies such as artificial intelligence and data science, molecular and CFD simulations, easy-to-use process simulation packages, microfluidics, 3D-printing, among many others. Such technologies can now be implemented and scaled up quickly and at relatively low cost in low-budget production facilities, critical to moving to sustainable and marketable products worldwide. Discovering novel antimicrobial peptides rationally and cost-effectively has emerged as one of the significant challenges of modern biotechnology. Thus far, this process has been tedious and costly, resulting in molecules with activities far below those needed to address the current challenge of microbial resistance to antibiotics that takes the lives of thousands of people around the world every year. Finally, the book also highlights how multidisciplinary teams have assembled to address the challenges of manufacturing, biological testing, and clinical trials to finally reach complete translation. - Covers computational tools (including emerging artificial intelligence algorithms) and microfluidic systems for discovery and high-throughput screening of AMPs - Discusses the application of bioprocess engineering scale-up approaches for AMPs' production and purification with the aid of process simulation tools and rapid prototyping - Highlights user-centered design and formulation of products with AMPs - Describes the whole pipeline for AMPs production
Author: Kayvon Modjarrad
Publisher: Elsevier
ISBN: 0323221696
Category : Medical
Languages : en
Pages : 365
Get Book Here
Book Description
While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they're creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. - Gathers discussions of a large number of applications of polymers in medicine in one place - Provides an insight into both the legal and clinical implications of device design - Relevant to industry, academic and medical professionals - Presents the latest developments in the field, including medical devices on a nano-scale
Author: Jack Wong
Publisher: CRC Press
ISBN: 0429996764
Category : Medical
Languages : en
Pages : 475
Get Book Here
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
Get Book Here
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 : 622
Get Book Here
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
Get Book Here
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
Get Book Here
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
Get Book Here
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: Gottfried Schmalz
Publisher: Springer Science & Business Media
ISBN: 3540777822
Category : Medical
Languages : en
Pages : 392
Get Book Here
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.
