Qualification de performance des systèmes environnementaux d'un local pharmaceutique pour la production de vaccin PDF Download
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Author: Delphine Lafargue
Publisher:
ISBN:
Category :
Languages : fr
Pages : 111
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Book Description
La production des vaccins est un enjeu majeur pour la santé publique. La production de vaccin est complexe et repose sur un savoir-faire et une capacité d'innovation forte dans le domaine de la biotechnologie. La production des vaccins est soumise à de nombreuses réglementations. La maitrise de l'environnement des ZAC est un axe majeur pour la production des vaccins. En effet, une contamination de l'environnement au niveau du produit peut avoir un impact grave sur la santé du patient. De ce fait, les autorités de santé sont attentives à la maitrise de l'environnement des ZAC. La qualification des systèmes environnementaux permet de démontrer la maitrise de l'environnement d'une ZAC ainsi que sa conformité aux spécifications en vigueur. La qualification permet de générer une base de données des résultats d'environnement exploitables pour servir de référence au suivi de routine.
Author: Delphine Lafargue
Publisher:
ISBN:
Category :
Languages : fr
Pages : 111
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Book Description
La production des vaccins est un enjeu majeur pour la santé publique. La production de vaccin est complexe et repose sur un savoir-faire et une capacité d'innovation forte dans le domaine de la biotechnologie. La production des vaccins est soumise à de nombreuses réglementations. La maitrise de l'environnement des ZAC est un axe majeur pour la production des vaccins. En effet, une contamination de l'environnement au niveau du produit peut avoir un impact grave sur la santé du patient. De ce fait, les autorités de santé sont attentives à la maitrise de l'environnement des ZAC. La qualification des systèmes environnementaux permet de démontrer la maitrise de l'environnement d'une ZAC ainsi que sa conformité aux spécifications en vigueur. La qualification permet de générer une base de données des résultats d'environnement exploitables pour servir de référence au suivi de routine.
Author:
Publisher:
ISBN:
Category : Immigrants
Languages : en
Pages : 4
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Book Description
Author: Barry R. Bloom
Publisher: Academic Press
ISBN: 012805400X
Category : Medical
Languages : en
Pages : 666
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Book Description
The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment. This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child's risk. - Provides insights into diseases that could be prevented, along with the challenges facing research scientists in the world of vaccines - Gives new ideas about future vaccines and concepts - Introduces new vaccines and concepts - Gives ideas about challenges facing public and private industrial investors in the vaccine area - Discusses the problem of declining immunization rates and vaccine hesitancy
Author: Brian K. Nunnally
Publisher: Springer
ISBN: 3662450240
Category : Medical
Languages : en
Pages : 669
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Book Description
This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.
Author:
Publisher:
ISBN: 9789240698345
Category : MEDICAL
Languages : en
Pages :
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Book Description
Author: Donald Ainslie Henderson
Publisher:
ISBN: 9781591027225
Category : Medical
Languages : en
Pages : 334
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Book Description
Foreword by Richard Preston, author of The Hot Zone; Preface by David M. Oshinsky. The personal story of how Dr Henderson led the World Health Organization's campaign to eradicate smallpoxthe only disease in history to have been deliberately eliminated.
Author: Tom Forester
Publisher: MIT Press
ISBN: 9780262060950
Category : History
Languages : en
Pages : 684
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Book Description
This text is aimed at students of information technology, as well as business students and general readers.
Author: John Henry Lorentz
Publisher: Historical Dictionaries of Asia, Oceania, and the Middle East
ISBN:
Category : History
Languages : en
Pages : 570
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Book Description
Provides an overview of specific events, movements, people, political and social groups, places, trends, and chronology. Allows for considerable exploration of a number of historical and contemporary topics and issues. The modern period, defined as 1800-present, is covered extensively.
Author: Jo N. Hays
Publisher: Bloomsbury Publishing USA
ISBN:
Category : History
Languages : en
Pages : 654
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Book Description
Balancing current and historical issues, this volume of essays covers the most significant worldwide epidemics from the Black Death to AIDS. Great pandemics have resulted in significant death tolls and major social disruption. Other "virgin soil" epidemics have struck down large percentages of populations that had no previous contact with newly introduced microbes. Written by a specialist in the history of science and medicine, the essays in this volume discuss pandemics and epidemics affecting Europe, the Americas, Africa, and Asia, covering diseases in ancient times to the present. Each entry combines biological and social information to form a picture of the significance of epidemics that have shaped world history. The essays cover the areas of major pandemics, virgin soil epidemics, disruptive shocks, and epidemics of symbolic interest. Included are facts about what an epidemic was, where and when it occurred, how contemporaries reacted, and the unresolved historical issues remaining. This fascinating material is written at a level suitable for scholars and the general public.
Author: Maria-Luisa Escobar
Publisher: Brookings Institution Press
ISBN: 0815705468
Category : Social Science
Languages : en
Pages : 239
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Book Description
Over the past twenty years, many low- and middle-income countries have experimented with health insurance options. While their plans have varied widely in scale and ambition, their goals are the same: to make health services more affordable through the use of public subsidies while also moving care providers partially or fully into competitive markets. Until now, however, we have known little about the actual effects of these dramatic policy changes. Understanding the impact of health insurance-based care is key to the public policy debate of whether to extend insurance to low-income populationsand if so, how to do itor to serve them through other means.
