Qualit In Biotech E Pharma
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Biotechnology
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Author : Kenneth E Avis
language : en
Publisher: CRC Press
Release Date : 2019-08-30
Biotechnology written by Kenneth E Avis and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-30 with categories.
Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.
Quality By Design For Biopharmaceuticals
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Author : Anurag S. Rathore
language : en
Publisher: Wiley-Interscience
Release Date : 2009-06-22
Quality By Design For Biopharmaceuticals written by Anurag S. Rathore and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-06-22 with Science categories.
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Qualit In Biotech E Pharma
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Author :
language : it
Publisher:
Release Date : 2011-04-08
Qualit In Biotech E Pharma written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-08 with categories.
Quality Operations Procedures For Pharmaceutical Api And Biotechnology
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2012-06-06
Quality Operations Procedures For Pharmaceutical Api And Biotechnology written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-06 with Medical categories.
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.
Nonclinical Statistics For Pharmaceutical And Biotechnology Industries
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Author : Lanju Zhang
language : en
Publisher: Springer
Release Date : 2016-01-13
Nonclinical Statistics For Pharmaceutical And Biotechnology Industries written by Lanju Zhang and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-13 with Medical categories.
This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.
Quality Operations Procedures For Pharmaceutical Api And Biotechnology
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2012-06-06
Quality Operations Procedures For Pharmaceutical Api And Biotechnology written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-06 with Medical categories.
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-
Quality Management In Scientific Research
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Author : Antonella Lanati
language : en
Publisher: Springer
Release Date : 2018-05-23
Quality Management In Scientific Research written by Antonella Lanati and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-23 with Medical categories.
In recent years, the attention of the scientific and social community has not solely been on producing new findings, but increasingly also on the related issues of the reliability, safety, and efficacy of the discoveries made, as well as the efficient and effective use of resources. The adoption of management models and tools can help scientists to improve their research, ensuring valuable, robust and dependable outcomes. Quality disciplines have been widely used for decades in industrial and business fields, building a knowledge base that can be translated and exploited, much to the advantage of scientific research. However, quality references in scientific research are still extremely rare and largely limited to an international guideline and a few sector-specific standards. Despite WHO and EU Commission campaigns, there are still precious few practical texts that offer researchers guidance on quality principles and provide simple tools and methodologies for their daily work. The book, starting from the problem of the reproducibility of scientific results and the substantial contribution that the Quality approach can make to research (Chapter 1), introduces the reader to key principles and basic concepts of Quality and illustrates both general and research-specific quality standards, paving the way for further discussion (Chapter 2). In turn, Chapter 3 presents detailed applications of Quality principles in various aspects of research, from study and ethics to materials and equipment management. Chapters 4 and 5, respectively, are devoted to Quality tools and Quality methodologies, as well as soft skills, all of which are valuable to scientific experimentation and study management. The concepts and practical tools discussed are extensively illustrated with examples from actual applications in scientific research.
Proceedings Of 2nd World Congress On Patient Safety Quality Healthcare 2018
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Author : ConferenceSeries
language : en
Publisher: ConferenceSeries
Release Date :
Proceedings Of 2nd World Congress On Patient Safety Quality Healthcare 2018 written by ConferenceSeries and has been published by ConferenceSeries this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
June 21-22, 2018 Dublin, Ireland Key topics : Health Care, Home Care Safety, Infection Prevention and Control (IPAC), Medication Safety, Surgical Care Safety, Gynecology & Obstetrics, Treatment & Safe Care, Hospital-Acquired Infections, Errors in Patient Safety, Primary Healthcare, Clinical Research, Psychiatry and Mental Health, Patient Safety & Nursing Education, Infections, Womens Health & Patient Safety, Pediatric & Geriatric Patient Safety, Trauma & Critical Care, Patient Safety Factors, Occupational Health and Safety, Nursing Care & Practice, Patient Safety, Cancer Nursing,
Pharmaceutical Biotechnology
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Author : Adalberto Pessoa
language : en
Publisher: CRC Press
Release Date : 2021-07-16
Pharmaceutical Biotechnology written by Adalberto Pessoa and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-07-16 with Medical categories.
Pharmaceutical Biotechnology: A Focus on Industrial Application covers the development of new biopharmaceuticals as well as the improvement of those being produced. The main purpose is to provide background and concepts related to pharmaceutical biotechnology, together with an industrial perspective. This is a comprehensive text for undergraduates, graduates and academics in biochemistry, pharmacology and biopharmaceutics, as well as professionals working on the interdisciplinary field of pharmaceutical biotechnology. Written with educators in mind, this book provides teachers with background material to enhance their classes and offers students and other readers an easy-to-read text that examines the step-by-step stages of the development of new biopharmaceuticals. Features: Discusses specific points of great current relevance in relation to new processes as well as traditional processes Addresses the main unitary operations used in the biopharmaceutical industry such as upstream and downstream Includes chapters that allow a broad evaluation of the production process Dr. Adalberto Pessoa Jr. is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo and Visiting Senior Professor at King’s College London. He has experience in enzyme and fermentation technology and in the purification processes of biotechnological products such as liquid–liquid extraction, cross-flow filtration and chromatography of interest to the pharmaceutical and food industries. Dr. Michele Vitolo is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo. He has experience in enzyme technology, in immobilization techniques (aiming the reuse of the biocatalyst) and in the operation of membrane reactors for obtaining biotechnological products of interest to the pharmaceutical, chemical and food industries. Dr. Paul F. Long is Professor of Biotechnology at King's College London and Visiting International Research Professor at the University of São Paulo. He is a microbiologist by training and his research uses a combination of bioinformatics, laboratory and field studies to discover new medicines from nature, particularly from the marine environment.
Gmp Audits In Pharmaceutical And Biotechnology Industries
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Author : Mustafa Edik
language : en
Publisher: CRC Press
Release Date : 2024-06-28
Gmp Audits In Pharmaceutical And Biotechnology Industries written by Mustafa Edik and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-06-28 with Medical categories.
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
