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Book La gestion des risques de contamination crois  e a  roport  e sur un site de production pharmaceutique de formes solides non st  riles

Download or read book La gestion des risques de contamination crois e a roport e sur un site de production pharmaceutique de formes solides non st riles written by Romain Havart and published by . This book was released on 2016 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: La maîtrise des risques de contamination croisée durant la production des médicaments représente un enjeu majeur pour toute entreprise pharmaceutique. La réglementation insiste sur la prévention de tels risques, mais elle est moins stricte pour les médicaments non stériles que pour ceux stériles. L'une des sources potentielles d'un tel défaut qualité est l'air. Ainsi, une démarche rigoureuse doit être mise en place pour maîtriser les risques à l'origine d'une contamination croisée aéroportée, en s'appuyant sur les référentiels normatifs existants pour la qualité particulaire de l'air. Tout d'abord, une analyse des risques de contamination croisée aéroportée est établie pour identifier et évaluer les risques de chaque produit, permettant de mettre en place des actions adaptées pour les réduire, au niveau des locaux, du traitement d'air et des surveillances. Enfin, les risques doivent aussi être communiqués et revus périodiquement pour que la maîtrise soit pleinement efficace.

Book La d  contamination par voie a  rienne des locaux dans l industrie pharmaceutique

Download or read book La d contamination par voie a rienne des locaux dans l industrie pharmaceutique written by Mickael Jaffar and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'industrie pharmaceutique est un secteur regroupant les activités de recherche, de fabrication et de commercialisation des médicaments à usage humain et vétérinaire. Un site de production peut fabriquer des médicaments en formes sèches (comprimés, gélules, etc.), semi-solides (crème, pommade, etc.) et liquides (sirop) dont font parties les formes injectables (ampoules, seringues auto-injectables, etc.) entres autres. La fabrication d'un médicament stérile impose des exigences particulières de production visant à réduire au minimum les risques de contamination microbienne, particulaire et par des substances pyrogènes (bactérienne ou chimique). Pour maîtriser ces risques de contamination, la fabrication doit se faire obligatoirement dans une ZAC. Travailler dans une salle propre consiste en une maîtrise de la contamination du milieu, matériel, mains d'œuvre, matières premières et méthodes tout au long du cycle de production d'un médicament. La conception, le nettoyage et la désinfection sont des critères permettant l'obtention d'une salle propre (BPF 2015, LD1 et glossaire). On peut également parler de zone propre, qui selon la norme ISO 14644 se définit comme un «espace dédié dans lequel la concentration des particules en suspension dans l'air est maîtrisée et qui est construit et utilisé de façon à minimiser l'introduction, la production et la rétention de particules à l'intérieur de la pièce, et dans laquelle d'autres paramètres pertinents, tels que la température, l'humidité et la pression sont maîtrisés comme il convient». Le terme de zone propre englobe donc d'autres caractéristiques par rapport aux ZAC. Un moyen d'optimisation de la désinfection est la mise en place d'un procédé de décontamination par voie aérienne. Ces procédés sont encadrés par un contexte réglementaire, dans le respect des règles HSE. Les industries pharmaceutiques ont le choix entre deux procédés de décontamination, l'un utilisant le peroxyde d'hydrogène seul et l'autre en association avec l'acide peracétique.

Book Impact des contaminations crois  es en industrie pharmaceutique

Download or read book Impact des contaminations crois es en industrie pharmaceutique written by Célia Sorrentino and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'enjeu majeur pour garantir la sécurité des produits pharmaceutiques est de maîtriser les risques liés à la présence de contaminants, quels que soient leur nature et leur mode d'administration. L'identification et la maîtrise des sources potentielles de contamination sont essentielles pour assurer la qualité des produits fabriqués. Il est donc important d'identifier et d'évaluer les risques, afin de mettre en œuvre des mesures préventives qui éliminent le risque ou le réduisent à un niveau acceptable. La mission principale de ce travail est de contrôler la contamination sur un site de production de formes sèches. L'objectif est de mettre en place un système de gestion de la qualité et une cartographie représentant les différents flux de production. Ce projet proactif permet aux équipes de production et au département d'assurance qualité d'être plus rapides et plus efficaces face à la contamination.

Book Gestion des risques qualit     cas d une contamination particulaire au cours de la production de comprim  s

Download or read book Gestion des risques qualit cas d une contamination particulaire au cours de la production de comprim s written by Laurine Deher and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'industrie pharmaceutique est soumise à des exigences réglementaires en constante évolution. Ces exigences imposent aux industriels de déployer un système qualité efficace. La gestion des risques est devenue une préoccupation centrale pour l'industrie pharmaceutique et est aujourd'hui reconnue comme une composante importante d'un système qualité efficace. Afin de mener au mieux cette gestion des risques, les Bonnes Pratiques de Fabrication et les ICH donnent des directives. La contamination qu'elle soit particulaire, microbiologique, chimique ou encore croisée, représente un risque pouvant impacter la qualité du médicament. Quel que soit le type de contamination, celle-ci peut survenir tout au long de la production du médicament. La gestion des risques permettra aux entreprises pharmaceutiques d'identifier les risques de contamination, les analyser et les évaluer. Ainsi, des actions pourront être mises en place afin de maitriser le risque. A travers un cas pratique, cette thèse illustrera la démarche qualité mise en place par l'industrie pharmaceutique lors d'un cas de contamination particulaire survenue au cours de la production du comprimé. Ce sujet sera traité en abordant dans une première partie des notions générales de production des comprimés ainsi que des notions réglementaires. Une deuxième partie s'attachera à définir le rôle de l'Assurance Qualité, les différents types de contamination, leur gestion et leur impact. Enfin, la troisième partie illustrera un cas pratique de contamination particulaire survenu au cours de la production. Cette dernière partie permettra de mettre en avant la gestion des risques et les différents outils qualité utilisés face à ce type d'anomalie.

Book Innovate Bristol

    Book Details:
  • Author : Sven Boermeester
  • Publisher :
  • Release : 2019-12
  • ISBN : 9781949677072
  • Pages : pages

Download or read book Innovate Bristol written by Sven Boermeester and published by . This book was released on 2019-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.

Book What is the Code of Conduct for Responsible Fisheries

Download or read book What is the Code of Conduct for Responsible Fisheries written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2001 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: The actual Code of conduct is also available (1996) (ISBN 9251038341).

Book Rational Phytotherapy

    Book Details:
  • Author : Volker Schulz
  • Publisher : Springer Science & Business Media
  • Release : 2013-03-09
  • ISBN : 3662096668
  • Pages : 432 pages

Download or read book Rational Phytotherapy written by Volker Schulz and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: All practitioners and pharmacists interested in treatment with herbal remedies should have this book at their disposal. It is the definitive practice-oriented introduction - now in its fifth edition - to phytotherapy. Methodically classified by organic systems and fields of application, the text provides a quick insight into dosage, form of application and effects of the most important herbal remedies. Only those herbal remedies that are of pharmacological and clinical efficiency have been considered. The authors are highly experienced in the field of postgraduate medical education, and, with this work, present an indispensable reference book for the medical practice.

Book Contemporary Criminological Issues

Download or read book Contemporary Criminological Issues written by Carolyn Côté-Lussier and published by University of Ottawa Press. This book was released on 2020-05-05 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contemporary Criminological Issues tackles some of today’s most pressing social issues, from the criminalization of Indigenous peoples to interpersonal violence, border control, and armed conflicts. This book advances cutting-edge theories and methods, with the aim of moving beyond the scholarship that reproduces insecurity and exclusion. The breadth of approaches encompasses much of the current critical criminological scholarship, serving as a counterpoint to the growth of managerial and administrative criminologies and the rise of explicitly exclusionary and punitive state policies and practices with respect to ‘crime’ and ‘security.’ This edited collection featuring two books, one in English and one in French, includes important contributions to knowledge and public policy by eminent experts and emerging scholars. This book is published in English.

Book Tolerance  Democracy  and Sufis in Senegal

Download or read book Tolerance Democracy and Sufis in Senegal written by Mamadou Diouf and published by Columbia University Press. This book was released on 2013 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection critically examines "tolerance," "secularism," and respect for religious "diversity" within a social and political system dominated by Sufi brotherhoods. Through a detailed analysis of Senegal's political economy, essays trace the genealogy and dynamic exchange among these concepts while investigating public spaces and political processes and their reciprocal engagement with the state, Sunni reformist and radical groups, and non-religious organizations. The anthology provides a rich and nuanced historical ethnography of the formation of Senegalese democracy, illuminating the complex trajectory of the Senegalese state and reflecting on similar postcolonial societies. Offering rare perspectives on the country's "successes" since liberation, the volume identifies the role of religion, gender, culture, ethnicity, globalization, politics, and migration in the reconfiguration of the state and society, and it makes an important contribution to democratization theory, Islamic studies, and African studies.

Book One Welfare in Practice

    Book Details:
  • Author : Tanya Stephens
  • Publisher : CRC Press
  • Release : 2021-10-25
  • ISBN : 1000459608
  • Pages : 294 pages

Download or read book One Welfare in Practice written by Tanya Stephens and published by CRC Press. This book was released on 2021-10-25 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal welfare has long been recognised as central to the role of the veterinary professional, but this is increasingly aligned with the welfare of humans and the broader environment in which we co-exist. This is the first book dedicated to the role of the veterinarian in One Welfare, a concept that recognises the interconnections between animal welfare, human wellbeing, and the environment. The book demonstrates, through a wide range of international case studies, why professional ethics and the use of good evidence is integral to this role. Contributors bring a rich variety of writings, each with their own perception of the role of the veterinarian in improving animal welfare and human wellbeing. One Welfare in Practice: The Role of the Veterinarian emphasises the importance of interdisciplinary collaboration and solutions: it is essential that veterinary practitioners recognise when other professionals or disciplines need to be consulted to benefit both animals and humans. With its multiple, fascinating approaches to One Welfare, this book will inform and inspire the veterinarian to find areas where collaborative action reaps the greatest rewards. This unique book shows how veterinarians can and are contributing to improving animal and human welfare, offering practical advice as to how the profession can further engage in One Welfare in a range of settings.

Book A German English Dictionary for Chemists

Download or read book A German English Dictionary for Chemists written by Austin McDowell Patterson and published by . This book was released on 1935 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book West Africa s Women of God

Download or read book West Africa s Women of God written by Robert M. Baum and published by Indiana University Press. This book was released on 2015-11-09 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: West Africa's Women of God examines the history of direct revelation from Emitai, the Supreme Being, which has been central to the Diola religion from before European colonization to the present day. Robert M. Baum charts the evolution of this movement from its origins as an exclusively male tradition to one that is largely female. He traces the response of Diola to the distinct challenges presented by conquest, colonial rule, and the post-colonial era. Looking specifically at the work of the most famous Diola woman prophet, Alinesitoué, Baum addresses the history of prophecy in West Africa and its impact on colonialism, the development of local religious traditions, and the role of women in religious communities.

Book Aquaculture Development

Download or read book Aquaculture Development written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 1997 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides annotations to the Principles of Article 9 of the Code of Conduct for Responsible Fisheries. These annotations are meant to serve as general guidance, and should be taken as suggestions or observations intended to assist those interested in identifying their own criteria and options for actions, as well as partners for collaboration, in support of sustainable aquaculture development.

Book Shrines of the Slave Trade

Download or read book Shrines of the Slave Trade written by Robert M. Baum and published by Oxford University Press. This book was released on 1999-05-13 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this groundbreaking work, Robert Baum seeks to reconstruct the religious and social history of the Diola communities in southern Senegal during the precolonial era, when the Atlantic slave trade was at its height. Baum shows that Diola community leaders used a complex of religious shrines and priesthoods to regulate and contain the influence of the slave trade. He demonstrates how this close involvement with the traders significantly changed Diola religious life.

Book Gut Feeling and Digestive Health in Nineteenth Century Literature  History and Culture

Download or read book Gut Feeling and Digestive Health in Nineteenth Century Literature History and Culture written by Manon Mathias and published by Springer. This book was released on 2018-11-17 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book considers the historical and cultural origins of the gut-brain relationship now evidenced in numerous scientific research fields. Bringing together eleven scholars with wide interdisciplinary expertise, the volume examines literal and metaphorical digestion in different spheres of nineteenth-century life. Digestive health is examined in three sections in relation to science, politics and literature during the period, focusing on Northern America, Europe and Australia. Using diverse methodologies, the essays demonstrate that the long nineteenth century was an important moment in the Western understanding and perception of the gastroenterological system and its relation to the mind in the sense of cognition, mental wellbeing, and the emotions. This collection explores how medical breakthroughs are often historically preceded by intuitive models imagined throughout a range of cultural productions.

Book Sheep and Goat Production

Download or read book Sheep and Goat Production written by I. E. Coop and published by Elsevier Science & Technology. This book was released on 1982 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ecology and distribution; Breeding; Reproduction; Maintenance and growth; Pregnancy; Lactation of suckling ewes and does; Nutritional diseases; Infectious diseases of sheep and goats; Internal parasites of sheep and goats; External parasites of sheep and goats; Growth and characteristics of wool and hair; Wiik grading and marketing; Livestock and meat marketing and grading; Carcase and meat qualities; Milk production in sheep and goats; Systems, biological and economic efficiencies; Very extensive systems; Extensive grazing systems; Intensive grassland systems; Intensive arable systems; Very intensive systems; Government controlled systems; Migratory (Transhumance) systems; Nomadic systems; Village and smallholder systems; List of contributors.

Book Nigerian Pentecostalism

    Book Details:
  • Author : Nimi Wariboko
  • Publisher : Boydell & Brewer
  • Release : 2014
  • ISBN : 1580464904
  • Pages : 382 pages

Download or read book Nigerian Pentecostalism written by Nimi Wariboko and published by Boydell & Brewer. This book was released on 2014 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part 1. Origins and spirituality of Nigerian Pentecostalism. Sources of Nigerian pentecostalism --The spell of the invisible --Excremental visions in postcolonial Pentecostalism --Desire and disgust : ways of being for God --The Pentecostal self : from body to body politic --Part 2. Ethical vision of Nigerian Pentecostal spirituality. Politics: between ontology and spiritual warfare --Miracles, sovereignty, and community --Altersovereignty and virtue of Pentecostal friendship --Spirituality and the weight of blackness --"This neighbor cannot be loved!" : invisibility and nudity of the "Pentecostal other"--Pentecostalism and Nigerian society.