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Qualification Dune Chaine De Repartition Et Validation Du Processus De Conditionnement
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Book Synopsis Qualification d'une chaine de répartition et validation du processus de conditionnement by : Camille Chevaux
Download or read book Qualification d'une chaine de répartition et validation du processus de conditionnement written by Camille Chevaux and published by . This book was released on 2013 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: Depuis le premier mai 2011, date d'entrée en application de la directive européenne 2004/24/CE relative aux médicaments traditionnels à base de plantes, les fabricants de ces médicaments sont tenus d'assurer la qualité pharmaceutique de leurs produits. A ce titre, les fabricants doivent garantir la qualité, l'efficacité et la sécurité des médicaments en prouvant que leur fabrication s'effectue dans des locaux et selon des procédés maîtrisés. La validation des procédés de fabrication, principal outil de l'assurance qualité, est alors mise en oeuvre pour répondre aux exigences de la réglementation en vigueur. La répartition et le conditionnement des plantes en vrac font partie des étapes déterminantes du procédé de fabrication. Ces opérations pharmaceutiques permettent non seulement la maîtrise des doses de principes actifs présentes dans chaque unité mais aussi la protection et l'identification des composants du médicament. La validation des procédés de répartition et de conditionnement est une nécessité afin de certifier la quantité de principe actif délivrée au patient et de prévenir tout risque de contamination ou une mauvaise identification du produit. Cette thèse d'exercice aborde les aspects organisationnels, techniques et légaux de la validation d'une chaine de répartition et de conditionnement. Elle traite cette validation dans son ensemble, depuis la stratégie de validation à mettre en place, les prérequis, la définition des paramètres critiques du procédé via une analyse de risques, les méthodes d'échantillonnage et les paramètres évalués, la définition des critères d'acceptation et de validité jusqu'au choix des tests et analyses réalisés. Une application à un cas réel complète les données théoriques et montre la méthodologie entreprise par une industrie pharmaceutique avec les difficultés auxquelles elle s'est confrontée
Book Synopsis RECEPTION, QUALIFICATION ET VALIDATION D'UNE CHAINE DE CONDITIONNEMENT POUR FORMES SEMI-SOLIDES by : NATACHA.. MAMDY
Download or read book RECEPTION, QUALIFICATION ET VALIDATION D'UNE CHAINE DE CONDITIONNEMENT POUR FORMES SEMI-SOLIDES written by NATACHA.. MAMDY and published by . This book was released on 2000 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Qualification d'une ligne de conditionnement by : Claire Emaille
Download or read book Qualification d'une ligne de conditionnement written by Claire Emaille and published by . This book was released on 2003 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: La qualification des équipements et la validation des process et procédés est un des principaux piliers de la qualité dans l'industrie pharmaceutique. La qualification d'une ligne de répartition et de conditionnement préalable à la mise en service va permettre de réduire considérablement les risques de production de non-conformités. Pour y parvenir des protocoles sont mis en place comprenant trois étapes : une qualification d'installation, une qualification opérationnelle et une qualification de performance qui correspond à la validation. La validation concerne à la fois le conditionnement et le nettoyage. La mise en place d'un système documentaire complet et efficace est indispensable au démarrage d'une ligne de conditionnement.
Book Synopsis VALIDATION ET QUALIFICATION D'UNE LIGNE DE CONDITIONNEMENT DE GELULES by : ISABELLE.. FRAISSE
Download or read book VALIDATION ET QUALIFICATION D'UNE LIGNE DE CONDITIONNEMENT DE GELULES written by ISABELLE.. FRAISSE and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Qualification et validation d’une ligne de conditionnement primaire pour préparations injectables by : Charles Haendler
Download or read book Qualification et validation d’une ligne de conditionnement primaire pour préparations injectables written by Charles Haendler and published by . This book was released on 2016 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: La fabrication de médicaments, et plus particulièrement la production de médicaments injectables est soumise à un haut degré d’exigences techniques, humaines et réglementaires. La stérilisation et son maintien est l’étape primordiale dans le processus de production de ce type de médicaments. En fonction de la nature des principes actifs, excipients ou encore des articles de conditionnement, il existe différentes méthodes de stérilisation décrites au niveau des Bonnes pratiques de fabrication. La qualification des équipements et la validation des procédés est un enjeu majeur en production pharmaceutique, puisque, toutes les étapes déroulées au cours de ces activités permettent d’identifier et de corriger des anomalies afin de maitriser le risque de non-conformité, et donc, de répondre aux exigences de la qualité. La production d’injectables conditionnés en flacon nécessite une étape de lavage, de stérilisation, de répartition et de mirage. La qualification d’installation, opérationnelle et de performances d’une telle ligne de conditionnement vérifie, contrôle et approuve l’ensemble des paramètres de l’installation.
Download or read book Doing Business 2020 written by World Bank and published by World Bank Publications. This book was released on 2019-11-21 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Seventeen in a series of annual reports comparing business regulation in 190 economies, Doing Business 2020 measures aspects of regulation affecting 10 areas of everyday business activity.
Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl
Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian
Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Author :North Atlantic Treaty Organization. Advisory Group for Aerospace Research and Development Publisher : ISBN 13 :9789283600046 Total Pages : pages Book Rating :4.6/5 ( download)
Book Synopsis AGARD Conference Proceedings by : North Atlantic Treaty Organization. Advisory Group for Aerospace Research and Development
Download or read book AGARD Conference Proceedings written by North Atlantic Treaty Organization. Advisory Group for Aerospace Research and Development and published by . This book was released on 1994 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Food and Agriculture Organization of the United Nations Publisher :Food & Agriculture Organization of the UN (FAO) ISBN 13 : Total Pages :32 pages Book Rating :4.:/5 (319 download)
Book Synopsis FAO Policy on Gender Equality by : Food and Agriculture Organization of the United Nations
Download or read book FAO Policy on Gender Equality written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Organization of the UN (FAO). This book was released on 2013 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The FAO Policy on Gender Equality provides a framework that guides the Organization's efforts to achieve gender equality in all its technical work and assesses results. The policy outlines FAO's goal and objectives related to gender equality and delineates an accountability structure for ensuring policy oversight and achievement of results."--Publisher's description.
Book Synopsis Interculturalism at the crossroads by : Mansouri, Fethi
Download or read book Interculturalism at the crossroads written by Mansouri, Fethi and published by UNESCO Publishing. This book was released on 2017-05-08 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Organisation mondiale de la santé Publisher :World Health Organization ISBN 13 :9241562625 Total Pages :310 pages Book Rating :4.2/5 (415 download)
Book Synopsis Enterobacter Sakazakii and Other Microorganisms in Powdered Infant Formula by : Organisation mondiale de la santé
Download or read book Enterobacter Sakazakii and Other Microorganisms in Powdered Infant Formula written by Organisation mondiale de la santé and published by World Health Organization. This book was released on 2004 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cases of listeriosis appear to be predominantly associated with ready-to-eat products. FAO and WHO have undertaken a risk assessment of Listeria monocytogenes in ready-to-eat foods, prepared and reviewed by an international team of scientists. Input was received from several international fora including expert consultations and Codex Alimentarius committee meetings as well as via public and peer review. This technical report provides complete documentation of the risk assessment, the approaches taken, the data and methodology used, and the results. It also contains four example assessments addressing the risk of listeriosis associated with fresh milk, ice cream, fermented meats and cold-smoked fish. These products were selected to represent typical classes of ready-to-eat products.
Download or read book Dairy Technology written by P. Walstra and published by CRC Press. This book was released on 1999-04-23 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes the efficient transformation of milk into a variety of products, focusing on the changes in raw material, and intermediate and final products, as well as the interactions between products and processing equipment. The book details the procedures for ensuring processing efficiency and product quality.
Book Synopsis Underground Disposal of Radioactive Wastes by : International Atomic Energy Agency
Download or read book Underground Disposal of Radioactive Wastes written by International Atomic Energy Agency and published by . This book was released on 1981 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis NATO Glossary of Terms and Definitions by : North Atlantic Treaty Organization
Download or read book NATO Glossary of Terms and Definitions written by North Atlantic Treaty Organization and published by CreateSpace. This book was released on 2013-03-08 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: NATO Glossary of terms and definitions (English and French). Listing terms of military significance and their definitions for use in NATO.
Book Synopsis Human Dignity in Context by : Dieter Grimm
Download or read book Human Dignity in Context written by Dieter Grimm and published by . This book was released on 2015-11 with total page 550 pages. Available in PDF, EPUB and Kindle. Book excerpt:
