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Book Plan de pr  vention des contaminations crois  es sur la ligne de conditionnement

Download or read book Plan de pr vention des contaminations crois es sur la ligne de conditionnement written by Erwan Le Dru and published by . This book was released on 2018 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le conditionnement pharmaceutique est l'étape où le médicament est inséré dans un emballage. Cette étape est réalisée dans un service spécifique d'un site de production pharmaceutique. Le conditionnement a des rôles très importants, il permet l'identification du médicament, il participe à la sécurisation de l'ensemble de la chaîne pharmaceutique, il assure également la promotion du bon usage du médicament, il favorise l'observance thérapeutique et, il est aussi un acteur majeur dans la sécurité d'emploi du médicament. L'un des principaux risques du processus de conditionnement est la contamination croisée. Les conséquences de cette anomalie peuvent être extrêmement graves pour le patient ainsi que pour l'entreprise. C'est pourquoi la prévention et l'élimination du risque de contamination croisée sont un défi quotidien et très important pour l'entreprise. L'un des moyens de contrôler ce risque est la mise en place d'un plan de prévention, qui a pour objectif de contrôler tous les éléments pouvant provoquer le défaut. L'objectif est de maîtriser les méthodes de conditionnement, de garantir la formation du personnel et l'utilisation correcte des équipements au sein de l'atelier.

Book Gestion du risque de contamination crois  e en industrie pharmaceutique

Download or read book Gestion du risque de contamination crois e en industrie pharmaceutique written by Camille Trehel and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'industrie pharmaceutique fait face à de nombreux risques pouvant altérer la qualité du médicament, ce qui pourrait porter atteinte à la santé publique. Face à de tels enjeux, les entreprises se dotent d'un système de management des risques conformément aux Bonnes Pratiques de Fabrication (BPF). La contamination croisée ou contamination d'un produit par un autre, est un risque qui génère des conséquences sur la sécurité du patient et pour l'entreprise mise en cause. La gestion du risque de contamination croisée a pris une importance croissante au cours des dernières années. Les BPF ont notamment été mises à jour en 2015 dans le but d'améliorer la prévention des contaminations croisée. Une démarche rigoureuse de gestion des risques Qualité et l'utilisation d'outils adaptés selon l'ICH Q9, sont alors nécessaires pour réduire ce risque. Les sources de contamination croisée sont multiples et peuvent survenir à toutes les étapes de la vie du médicament. Elles peuvent être liées à des défaillances d'origine technique ou organisationnelle : problèmes de nettoyage, de conception des locaux, de maîtrise des flux, de vide de ligne... Un outil de gestion des risques tel que l'AMDEC, ciblant un procédé en particulier, permet d'identifier efficacement les risques selon leur criticité. Suite à cette analyse du risque, des moyens de maîtrise de la contamination croisée sont mis en place par les industriels, tout en se conformant aux exigences des BPF. À travers cette étude, le risque de contamination croisée au sein d'un service de conditionnement sera abordé plus en détails.

Book Les mesures indispensables pour des vides de lignes conformes dans un atelier de conditionnement des comprim  s

Download or read book Les mesures indispensables pour des vides de lignes conformes dans un atelier de conditionnement des comprim s written by Nacima Ouali and published by . This book was released on 2005 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le conditionnement pharmaceutique des comprimés, tant par la conception que par la production, est l'une des étapes fondamentales de la fabrication du médicament. En effet, l'opération de conditionnement est une opération pharmaceutique d'emballage qui vise à garantir la qualité du médicament jusqu'à son utilisation ou sa péremption, en préservant l'intégrité du comprimé et du conditionnement primaire et en assurant la présence de toutes les informations légales et nécessaires pour le patient. C'est le service conditionnement, rattaché au département production, qui est responsable de cette activité. Cependant, l'un des risques majeurs auquel est confronté le service conditionnement est la contamination croisée. En effet, la similitude des matières premières (comprimés et articles de conditionnement) entre différents médicaments, est de plus en plus courante, ce qui engendre un risque accru de substitution d'un article de conditionnement par un autre ou d'un comprimé par un autre. Afin d'éviter les contaminations croisées, les Bonnes Pratiques de Fabrication (BPF) et l'Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) recommandent d'effectuer des vides de ligne entre deux productions pharmaceutiques. Ce sont des opérations critiques du processus de onditionnement qui visent à supprimer les articles de conditionnement, produits, éléments d'impression et documents de la production antérieure lorsque ceux-ci ne sont pas utiles à la nouvelle production. Pour effectuer un vide de ligne conforme aux exigences de l'AFSSAPS et des BPF, il est indispensable de mettre en place un dispositif qualité rigoureux qui couvre tous les aspects de cette opération. Cette démarche qualité s'articule sur trois systèmes : Un système de documentation de vides de ligne qui définit les bases communes à la réalisation des opérations de vide de ligne. Il comprend une procédure de vide de ligne, des modes opératoires et des relevés d'activité. Un système de formation rigoureux qui repose sur un programme de formation. Il permet de qualifier le personnel du service onditionnement aux opérations de vides de ligne. Un système d'évaluation de vides de ligne qui aura pour but d'identifier les lacunes des deux autres systèmes. Ils utilisent les outils suivants : les tableaux de bord des indicateurs qualité. Lors de mon stage de fin d'étude, j'ai pu éprouver l'efficacité de ces systèmes. En effet, j'ai amélioré un dispositif de modes opératoires de vides de ligne et conçue une formation aux opérations de vides de ligne. Cela m'a permis de souligner l'importance d'une documentation exhaustive, simple d'accès et à jour. D'autre part, le rôle de la formation est apparu déterminant dans la sensibilisation au problème des contaminations croisées.

Book Spalding  Elizabeth

    Book Details:
  • Author :
  • Publisher :
  • Release : 2000
  • ISBN :
  • Pages : pages

Download or read book Spalding Elizabeth written by and published by . This book was released on 2000 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The folder may include clippings, announcements, small exhibition catalogs, and other ephemeral items.

Book Clinical Management of Patients with Viral Haemorrhagic Fever

Download or read book Clinical Management of Patients with Viral Haemorrhagic Fever written by World Health Organization and published by World Health Organization. This book was released on 2016-05-03 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in March 2014 under the title "Clinical management of patients with viral haemorrhagic fever: a pocket guide for front-line health workers: interim emergency guidance for West Africa".

Book On Curiosity

    Book Details:
  • Author : Franck Cochoy
  • Publisher :
  • Release : 2016-07-25
  • ISBN : 9780995527706
  • Pages : 256 pages

Download or read book On Curiosity written by Franck Cochoy and published by . This book was released on 2016-07-25 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: What draws us towards a shop window display? What drives us to grab a special offer, to enter the privileged circle of premium newspaper subscribers, to peruse the pages of an enticing magazine? Without doubt, it is curiosity - that essential force of everyday action which invites us to break from our habits and to become transported beyond our very selves. Curiosity (whether healthy or unhealthy) is one of the favourite tricks of market seduction. Capturing a public - attracting the attention of a reader, seducing a customer, meeting the expectations of a user, persuading a voter ... - often requires the construction of a set of technical devices that can play upon people's inner motivations. Cochoy invites us to take a sociological trip into these cabinets of curiosity, accompanied throughout by Bluebeard, a fairy tale that is both a model of the genre and a pure curiosity machine. At once a work of history and economic anthropology, the book meticulously analyses the devices designed by markets to arouse, excite, and sustain curiosity: a window display, practices of 'teasing', packaging, bus shelters, mobile internet technologies, to name but a few. In the Bettencourt and Strauss-Kahn affairs and the Wikileaks controversy, Cochoy also uncovers the work of investigative journalism and its attention-grabbing 'scoops', revealing the secrets of the revealers of secrets. Available in English for the first time, this major work will arouse readers' curiosity over the course of its unusual and colourful journey. By the end, now better informed and more cautious, they will be able to identify the traps of which they are the target. So long as curiosity is kept at bay, at least!

Book Dictionary of Building and Civil Engineering

Download or read book Dictionary of Building and Civil Engineering written by Don Montague and published by Taylor & Francis. This book was released on 1996 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dual-language dictionary lists over 20,000 specialist terms in both French and English, covering architecture, building, engineering and property terms. It meets the needs of all building professionals working on projects overseas. It has been comprehensively researched and compiled to provide an invaluable reference source in an increasingly European marketplace.

Book Animal Traction in Africa

Download or read book Animal Traction in Africa written by Peter Munzinger and published by Deutsche Gesellschaft Fur Technische Zusammenarbeit. This book was released on 1982 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Slow Magic

Download or read book Slow Magic written by Philip G. Pardey and published by Intl Food Policy Res Inst. This book was released on 2001 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: A history of public agricultural R & D; The growing private sector; Research intensities; Global gaps in stocks of scientific knowledge; Agricultural biotechnologies; The rights to research.

Book Narratives of fear and safety

Download or read book Narratives of fear and safety written by Kaisa Kaukiainen and published by BoD - Books on Demand. This book was released on 2020-09-01 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essays in this edited volume, written in English and French, tackle the intriguing problems of fear and safety by analysing their various meanings and manifestations in literature and other narrative media. The articles bring forth new, cross-cultural interpretations on fear and safety through examining what kinds of genre-specific means of world-making narratives use to express these two affectivities. The articles also show how important it is to study these themes in order to understand challenges in times of global threats, such as the climate crisis. The main themes of the book are approached from various theoretical perspectives as related to their literary and cultural representations. Recent trends in research, such as affect and risk theory, serve as the basis for the discussion. The articles in the volume also draw from disciplines such as gender studies and trauma studies to examine the threats posed by collective fears and aggression on individuals' lives and propose ways of coping with fear. These themes are addressed also in articles analysing new adaptations of old myths that retell stories of the past. Many of the articles in the volume discuss apocalyptic and dystopian narratives that currently permeate the entire cultural landscape. Dystopian narratives do not only deal with future threats, such as totalitarianism, technocracy, or environmental disasters, but also suggest alternative ways of being and new hopes in the form of political resistance.

Book The Life Cycle of Pharmaceuticals in the Environment

Download or read book The Life Cycle of Pharmaceuticals in the Environment written by B.M. Peake and published by Elsevier. This book was released on 2015-11-13 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship. Encompasses the full lifecycle of common pharmaceuticals, from prescription and dispensing practices to their occurrence in a range of different types of natural waters and their environmental impact Explores the role of the healthcare system and its affect on users Beneficial for environmental engineers involved in the design and operation of appropriate degradation technologies of the pharmaceutical prescription and disposal practices

Book Before We Visit the Goddess

    Book Details:
  • Author : Chitra Banerjee Divakaruni
  • Publisher : Simon and Schuster
  • Release : 2017-04-25
  • ISBN : 1476792011
  • Pages : 240 pages

Download or read book Before We Visit the Goddess written by Chitra Banerjee Divakaruni and published by Simon and Schuster. This book was released on 2017-04-25 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A new novel from the author of Oleander Girl, a novel in stories, built around crucial moments in the lives of 3 generations of women in an Indian/Indian-American Family"--

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 The Microbiological Safety of Low Water Activity Foods and Spices

Download or read book The Microbiological Safety of Low Water Activity Foods and Spices written by Joshua B. Gurtler and published by Springer. This book was released on 2014-12-08 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: Low water activity (aw) and dried foods such as dried dairy and meat products, grain-based and dried ready-to-eat cereal products, powdered infant formula, peanut and nut pastes, as well as flours and meals have increasingly been associated with product recalls and foodborne outbreaks due to contamination by pathogens such as Salmonella spp. and enterohemorrhagic E. coli. In particular, recent foodborne outbreaks and product recalls related to Salmonella-contaminated spices have raised the level of public health concern for spices as agents of foodborne illnesses. Presently, most spices are grown outside the U.S., mainly in 8 countries: India, Indonesia, China, Brazil, Peru, Madagascar, Mexico and Vietnam. Many of these countries are under-developed and spices are harvested and stored with little heed to sanitation. The FDA has regulatory oversight of spices in the United States; however, the agency’s control is largely limited to enforcing regulatory compliance through sampling and testing only after imported foodstuffs have crossed the U.S. border. Unfortunately, statistical sampling plans are inefficient tools for ensuring total food safety. As a result, the development and use of decontamination treatments is key. This book provides an understanding of the microbial challenges to the safety of low aw foods, and a historic backdrop to the paradigm shift now highlighting low aw foods as vehicles for foodborne pathogens. Up-to-date facts and figures of foodborne illness outbreaks and product recalls are included. Special attention is given to the uncanny ability of Salmonella to persist under dry conditions in food processing plants and foods. A section is dedicated specifically to processing plant investigations, providing practical approaches to determining sources of persistent bacterial strains in the industrial food processing environment. Readers are guided through dry cleaning, wet cleaning and alternatives to processing plant hygiene and sanitation. Separate chapters are devoted to low aw food commodities of interest including spices, dried dairy-based products, low aw meat products, dried ready-to-eat cereal products, powdered infant formula, nuts and nut pastes, flours and meals, chocolate and confectionary, dried teas and herbs, and pet foods. The book provides regulatory testing guidelines and recommendations as well as guidance through methodological and sampling challenges to testing spices and low aw foods for the presence of foodborne pathogens. Chapters also address decontamination processes for low aw foods, including heat, steam, irradiation, microwave, and alternative energy-based treatments.

Book Comparative Oriental Manuscript Studies

Download or read book Comparative Oriental Manuscript Studies written by Comparative Oriental Manuscript Studies, COMSt and published by Tredition Gmbh. This book was released on 2015-01-21 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: The present volume is the main achievement of the Research Networking Programme 'Comparative Oriental Manuscript Studies', funded by the European Science Foundation in the years 2009-2014. It is the first attempt to introduce a wide audience to the entirety of the manuscript cultures of the Mediterranean East. The chapters reflect the state of the art in such fields as codicology, palaeography, textual criticism and text editing, cataloguing, and manuscript conservation as applied to a wide array of language traditions including Arabic, Armenian, Avestan, Caucasian Albanian, Christian Palestinian Aramaic, Coptic, Ethiopic, Georgian, Greek, Hebrew, Persian, Slavonic, Syriac, and Turkish. Seventy-seven scholars from twenty-one countries joined their efforts to produce the handbook. The resulting reference work can be recommended both to scholars and students of classical and oriental studies and to all those involved in manuscript research, digital humanities, and preservation of cultural heritage. The volume includes maps, illustrations, indexes, and an extensive bibliography.

Book Protected Area Management

    Book Details:
  • Author : Barbara Sladonja
  • Publisher : BoD – Books on Demand
  • Release : 2012-08-08
  • ISBN : 953510697X
  • Pages : 242 pages

Download or read book Protected Area Management written by Barbara Sladonja and published by BoD – Books on Demand. This book was released on 2012-08-08 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protected areas are at the base of the most national and international conservation strategies. Due to the many unpredictable elements in ecology matters, each protected area requires a case-specific set of guidelines but a common issue is how to cope with human interaction. The management of protected areas is replete with challenges and the only way to gain understanding and achieve greater management possibilities is to exchange experiences and knowledge. Environmental managers are aware of that and together with scientists are looking for more modern and better solutions, both with respect to natural resources and human interactions in many issues regarding nature protection. This publication presents reviews and research results on protected areas management, as well as 12 case studies derived from around the world with the aim of improving management effectiveness of the protected areas.