Download or read book Production de m dicaments st riles maitrise de la contamination et monitoring environnemental face aux nouvelles exigences de l annexe 1 des GMP written by Thomas Labro and published by . This book was released on 2020 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les médicaments injectables doivent être stériles, aparticulaires et apyrogènes. Ils doivent être produits dans des zones où le niveau de contamination microbiologique et particulaire est maitrisé. Afin de maitriser le niveau de contamination, trois grands principes doivent être appliqués : empêcher la contamination extérieure d'entrer, limiter les contaminations générées lors des activités de production et être en mesure de les éliminer. La notion de maitrise de la contamination est au cœur de la révision de l'annexe 1 des GMP. Cette thèse présente la production de médicaments stériles, les différents moyens de maitrise de la contamination ainsi que les nouvelles exigences de l'annexe 1 des GMP Européennes.

Download or read book Moyens de maitrise de l environnement aseptique et de d tection des contaminations written by Baptiste Lissarague and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: La production des médicaments est régie par un cadre réglementaire strict afin d'offrir aux patients l'accès à des produits de santé conformes et sûrs. En France, la production aseptique de médicaments stériles ne déroge pas à cette règle. Bien au contraire, le cadre réglementaire dicté par les BPF et notamment son annexe 1 est l'un des plus restrictifs rencontré dans l'industrie pharmaceutique. Dans l'optique de maintenir un environnement de production aseptique conforme aux exigences tout au long du procédé de fabrication, les industriels ont à leur disposition de nombreux moyens de maitrise de l'asepsie permettant de réduire les risques de contamination de l'environnement et des produits fabriqués. De plus, en association des moyens de maitrise de l'asepsie implémentés, la réglementation impose qu'un suivi environnemental des ZAC soit mené afin de détecter les potentielles contaminations et de démontrer que les moyens de maitrise de l'asepsie en place sont pertinents. Malgré l'adéquation des pratiques des industriels aux exigences réglementaires, malgré la pertinence des moyens de maitrise de l'environnement implémentés, malgré le travail consciencieux et les compétences du personnel de production, le risque zéro de contamination n'existe pas. En cas de perte de maitrise de l'asepsie d'une ZAC et de détection d'une contamination microbiologique, une anomalie relative au suivi environnemental est déclarée et doit être traitée selon un processus défini. L'objectif de ce dernier est d'identifier la cause racine de la perte de maitrise de l'asepsie et de permettre la mise en place, si nécessaire, de nouvelles mesures de prévention afin d'en éviter la récurrence.

Download or read book La surveillance environnementale des zones de production en industrie pharmaceutique written by Emmanuelle Gary and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: La surveillance des zones de production en industrie pharmaceutique est un élément clé pour maîtriser la contamination des produits fabriqués et assurer la sécurité du patient. Depuis ces dernières décennies les différents référentiels applicables au domaine pharmaceutique préconisent une approche basée sur les risques pour la maîtrise de la contamination dans les zones de production. Cette approche basée sur l'évaluation proactive des risques reste souvent abstraite de par la difficulté de détecter la contamination mais aussi de par l'exhaustivité des informations portées par les différents référentiels applicables qui peuvent perdre le lecteur. L'objectif de ce travail est de faciliter la compréhension des différentes recommandations et réglementations applicables à la maîtrise de la contamination (viable et non viable) en industrie pharmaceutique. Notamment en mettant en avant un cas concret d'application d'un plan de surveillance environnemental en industrie pharmaceutique. Dans un premier temps nous redéfinirons la contamination et l'intérêt de la maîtriser dans le cadre de la fabrication des produits de santé. Dans un second temps nous nous intéresserons à l'origine des zones de production à atmosphères contrôlées, à leur conception et à leur mise en place. Enfin nous mettrons en avant la mise en place d'un plan de surveillance environnementale mise au point à l'aide de la méthode d'analyse de risque HACCP, au sein de l'entreprise Sanofi.

Download or read book Multi party Elections in Africa written by Michael Cowen and published by . This book was released on 2002 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume contains electoral studies of multiparty politics in 14 African countries during the 1990s. Most are about national elections in Anglophone Africa. There are also less well-known examples from Sudan, Ethiopia and Guinea Bissau. The collection also features studies of the local elections in Namibia and of a significant by-election in Malawi. The multiparty period had been put, wherever possible, within the historical context of earlier elections in Africa. Questions addressed include: how did incumbent governing regimes learn to live with multiparty politics? Why have some elections been so closely fought and others have suffered from apathy? Why has there been relatively open political expression and activity when the elections have increased the political and economic manipulation by incumbent governments? Why have the elections of the 1990s been so marked by local and ethnic variations? To what extent did this wave of democracy result from pressure from donor countries?

Download or read book The ABC of Community Law written by Klaus-Dieter Borchardt and published by Luxembourg : Office for Official Publications of the European Communities. This book was released on 1994 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book City Making and Urban Governance in the Americas written by Clara Irazábal and published by Routledge. This book was released on 2017-03-02 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cities in both North and South America are confronting tremendous challenges in urban growth and management as they enter the new century. Curitiba in Brazil and Portland in Oregon, US are cities that have achieved recognition for exemplary urban planning programmes over the past three decades. As such, they provide particularly useful illustrations of the intense development pressures that many urban areas currently face. This book explores the dynamics of their urban governance, arguing that, in general, there has been a unique synergy derived from the combination of visionary leadership, innovative urban plans and effective citizen involvement. The book argues that, while urban design and architecture are key to the success in making cities livable and in augmenting the global reputations, such sensitive, innovative urban planning and design projects first need to be governed effectively and grounded within the specifics of their local cultures and existing built environments.

Download or read book Eurospeak written by François Gondrand and published by . This book was released on 1992 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: 2In 1993, nineteen countries from the Arctic to the Mediterranean will come together in the new European Economic Area (EEA) to form the world's largest market with a single language common to all-Eurospeak. Whether you are in business or a student, an aspiring Eurocrat or an armchair Euro-watcher, Francois Gondrand's book is essential reference to understanding the confusing, constantly changing and complex language of the European Community, the Single Market and the new EEA."

Download or read book Making the Difference written by Claudia Haarmann and published by . This book was released on 2009 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book 1992 Eurospeak Explained written by Stephen Crampton and published by . This book was released on 1992 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Urban Renewal Municipal Revitalization written by Hugh H. Schwartz and published by . This book was released on 2004 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first major account in English of one of the most successful urban renewals of the Twentieth Century, highlighting implementation of development visions. Likely to be of special interest to Latin Americanist, Urban Planners, and Transportation and Behavioral Economists

Download or read book Food for the Few written by Gerardo Otero and published by University of Texas Press. This book was released on 2008-07-15 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent decades have seen tremendous changes in Latin America's agricultural sector, resulting from a broad program of liberalization instigated under pressure from the United States, the IMF, and the World Bank. Tariffs have been lifted, agricultural markets have been opened and privatized, land reform policies have been restricted or eliminated, and the perspective has shifted radically toward exportation rather than toward the goal of feeding local citizens. Examining the impact of these transformations, the contributors to Food for the Few: Neoliberal Globalism and Biotechnology in Latin America paint a somber portrait, describing local peasant farmers who have been made responsible for protecting impossibly vast areas of biodiversity, or are forced to specialize in one genetically modified crop, or who become low-wage workers within a capitalized farm complex. Using dozens of examples such as these, the deleterious consequences are surveyed from the perspectives of experts in diverse fields, including anthropology, economics, geography, political science, and sociology. From Kathy McAfee's "Exporting Crop Biotechnology: The Myth of Molecular Miracles," to Liz Fitting's "Importing Corn, Exporting Labor: The Neoliberal Corn Regime, GMOs, and the Erosion of Mexican Biodiversity," Food for the Few balances disturbing findings with hopeful assessments of emerging grassroots alternatives. Surveying not only the Latin American conditions that led to bankruptcy for countless farmers but also the North's practices, such as the heavy subsidies implemented to protect North American farmers, these essays represent a comprehensive, keenly informed response to a pivotal global crisis.