La contamination particulaire dans les blocs stériles utilisés dans l'industrie pharmaceutique PDF Download
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Author: Philippe Sauvage
Publisher:
ISBN:
Category :
Languages : fr
Pages : 296
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Book Description
Author: Philippe Sauvage
Publisher:
ISBN:
Category :
Languages : fr
Pages : 296
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Author: Agnès Caddeo
Publisher:
ISBN:
Category :
Languages : fr
Pages : 328
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Author: Laurine Deher
Publisher:
ISBN:
Category :
Languages : fr
Pages : 0
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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.
Author: Stefan Condruz
Publisher:
ISBN:
Category :
Languages : fr
Pages : 268
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Les risques de contamination microbienne, particulaire et pyrogène sont présents partout dans une usine pharmaceutique stérile. Même si la conception puis la réalisation de toutes les installations sont parfaites, l’opérabilité de l’usine nécessite la mise en place d’un programme de nettoyage et désinfection qui met en jeu plusieurs départements. L’objectif de cette thèse est donc d’exposer les nombreux défis transversaux qu’on peut rencontrer dans le cadre de ce programme pour l’industrie pharmaceutique fabriquant des médicaments stériles à usage humain. En dressant une vision d’ensemble puis en montrant les enjeux et les points de vue des différents acteurs de ce processus complexe, on peut se faire une idée de la façon dont on pourrait obtenir un consensus pour concevoir un programme de nettoyage et de désinfection respectant les exigences du processus. Dans un premier temps la thèse présentera le contexte de l’industrie pharmaceutique stérile avec ses exigences juridiques, son système qualité pharmaceutique ainsi que les méthodes mises en œuvre pour gérer de façon épurée cet ensemble : contaminants, nettoyage et désinfection. Dans un deuxième temps les problématiques concernant le contrôle des entrées, le contrôle de l’environnement, les moyens de lutte contre la contamination, l’implémentation des méthodes et techniques ainsi que le suivi du programme seront détaillés pour donner des critères de choix vis-à-vis des solutions techniques disponibles actuellement
Author: LAURENT.. VINCENS
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
Publisher: World Health Organization
ISBN:
Category : Health & Fitness
Languages : en
Pages : 536
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Book Description
Evaluates the carcinogenic risks to humans posed by the use of four antiretroviral agents four DNA topoisomerase II inhibitors used in the treatment of cancer and an additional three pharmaceutical agents (hydroxyures phenolphthalein and vitamin K substances). The volume marks the first IARC evaluation of nucleoside analogs that act as antiviral agents. The evaluation responds in part to recent findings that zidovudine (AZT) an effective antiretroviral agent now being given to pregnant HIV-infected women to prevent maternal-to-fetal transmission of the virus is a transplacental carcinogen in mice. The opening monograph evaluates the carcinogenicity to humans of the antiretroviral nucleoside analogs zidovudine (AZT) zalcitabine (ddC) and didanosine (ddI) and the antiherpesvirus drug aciclovir. Of these aciclovir and didanosine could not be classified on the basis of available data. For zidovudine transplacental administration to mice resulted in an increased incidence and multiplicity of lung and liver tumours and in an increased incidence of female reproductive tract tumours in one study but not in another involving treatment at a lower dose. Despite observation of toxic effects in some studies of humans human carcinogenicity data were judged to provide inadequate evidence of carcinogenicity in humans. Zidovudine was classified as possibly carcinogenic to humans. Similar weaknesses in human carcinogenicity data for zalcitabine which consistently induces thymic lymphomas in mice resulted in its classification as possibly carcinogenic to humans. The second monograph evaluates four DNA topoisomerase II inhibitors: etoposide teniposide mitoxantrone and amsacrine. Of these etoposide - one of the most widely used and effective cytotoxic drugs in combination therapy - was classified as probably carcinogenic to humans and etoposide in combination with cisplatin and bleomycin was judged to be carcinogenic to humans. Teniposide was classified as probably carcinogenic to humans and mitoxantrone and amsacrine were classified as possibly carcinogenic to humans. Of the three pharmaceutical agents evaluated in the final monograph hydroxyurea which is widely used in cancer treatment and increasingly in combination with didanosine in HIV infection could not be classified. Phenolphthalein a widely used laxative now being withdrawn from the market in many countries because of toxicological concerns was classified as possibly carcinogenic. Vitamin K substances could not be classified on the basis of available evidence.
Author: Catherine Barnard
Publisher: Bloomsbury Publishing
ISBN: 184731869X
Category : Law
Languages : en
Pages : 337
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Book Description
The Cambridge Yearbook of European Legal Studies provides a forum for the scrutiny of significant issues in EU Law, the law of the European Convention on Human Rights, and Comparative Law with a 'European' dimension, and particularly those issues which have come to the fore during the year preceding publication. The contributions appearing in the collection are commissioned by the Centre for European Legal Studies (CELS) Cambridge, a research centre in the Law Faculty of the University of Cambridge specialising in European legal issues. The papers presented are at the cutting edge of the fields which they address, and reflect the views of recognised experts drawn from the University world, legal practice, and the institutions of both the EU and its Member States. Inclusion of the comparative dimension brings a fresh perspective to the study of European law, and highlights the effects of globalisation of the law more generally, and the resulting cross fertilisation of norms and ideas that has occurred among previously sovereign and separate legal orders. The Cambridge Yearbook of European Legal Studies is an invaluable resource for those wishing to keep pace with legal developments in the fast moving world of European integration. INDIVIDUAL CHAPTERS Please click on the link below to purchase individual chapters from Volume 13 through Ingenta Connect: www.ingentaconnect.com SUBSCRIPTION TO SERIES To place an annual online subscription or a print standing order through Hart Publishing please click on the link below. Please note that any customers who have a standing order for the printed volumes will now be entitled to free online access. www.hartjournals.co.uk/cyels/subs Editorial Advisory Board: Albertina Albors-Llorens, John Bell, Alan Dashwood, Simon Deakin, David Feldman, Richard Fentiman, Angus Johnston, John Spencer Founding Editors: Alan Dashwood and Angela Ward Ius Commune Prize 2012 Alexandre Saydé wrote Chapter 15 in this volume entitled: 'One Law, Two Competitions: An Enquiry into the Contradictions of Free Movement Law' and we are delighted to announce that he has been awarded the Ius Commune Prize 2012.
Author: John E Tedstrom
Publisher: Routledge
ISBN: 9780367303211
Category :
Languages : en
Pages : 239
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Book Description
This book highlights that Soviet economic planners and politicians must come to recognize the need to make fundamental changes, not simply incremental refinements, in the failing Soviet system. It examines the dynamics of the process of perestroika and the complexity of individual economic issues.
Author: Henry Allan Ironside
Publisher:
ISBN:
Category : Bible
Languages : en
Pages : 464
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Author: D H Lawrence
Publisher: Independently Published
ISBN:
Category :
Languages : en
Pages : 100
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"The Ladybird is a long tale or novella by D. H. Lawrence.It was first drafted in 1915 as a short story entitled The Thimble. Lawrence rewrote and extended it under a new title in December 1921 and sent the final version to his English agent on 9 January 1922. It was collected with two other tales, The Captain's Doll and The Fox, and the three novellas were then published in London by Martin Secker in March 1923 under the title The Ladybird and in New York by Thomas Seltzer as The Captain's Doll in April 1923."
