Download or read book Gestion du cycle de vie des m thodes analytiques dans les laboratoires de contr le qualit written by Ho Mai Thy Nguyen and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: La gestion du cycle de vie analytique (ALCM) est un processus continu qui vise à évaluer et à améliorer la performance des méthodes analytiques. Son cycle de vie commence par l'identification du besoin jusqu'à la fin d'utilisation ou remplacement de la méthode. Ce processus garantit la maîtrise de la performance et de la conformité d'une méthode analytique durant toute sa période d'utilisation. Afin de prioriser la méthode analytique à optimiser, une analyse de risque est réalisée sur l'ensemble des méthodes analytiques mises en œuvre dans le laboratoire de contrôle qualité (CQ) en utilisant la méthode Risk Ranking and Filtering. Ainsi, le dosage du Polysorbate 80 (PS80) a été identifié comme une méthode à haut risque qui devait être optimisée. Afin de concevoir un plan d'action de correction pour réduire ce risque, tous les collaborateurs du projet ont répondu à une série de questions liées à la technique, via un formulaire, pour dégager les actions à mettre en place. Les résultats positifs obtenus par le laboratoire de développement des méthodes analytiques (Analytical Technical Support) seront ensuite appliqués au service CQ. L'efficacité des actions sera mesurée dans les années suivantes en réévaluant le score critique obtenu lors de l'analyse de risque ALCM pour ce test.
Download or read book Gestion de la qualit au laboratoire contr le written by Thomas Poirot and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Les produits chimiques, de leur gestion à leur utilisation, constituent une branche très importante de la gestion de la qualité au sein d'un laboratoire de contrôle. La qualité des substances mises en oeuvre est primordiale afin d'assurer un contrôle qualité des produits pharmaceutiques juste et fiable.Dans ce contexte de gestion de la qualité, la durée limite d'utilisation des réactifs et des solvants après ouverture doit être déterminée.La nécessité de connaître la date limite d'utilisation des produits utilisés lors d'analyses physico-chimiques de médicaments se base sur plusieurs points :- La guide des Bonnes Pratiques de Fabrication, référentiel opposable, fixe les attentes réglementaires ;- La qualité des réactifs est aussi et surtout une composante majeure de la justesse et de la fiabilité des résultats d'analyses. Déterminer une date limite d'utilisation permet alors de maîtriser l'impact des réactifs et des solvants sur l'incertitude d'une mesure ;- La qualité d'un réactif ou d'un solvant n'est pas une donnée constante. À chaque étape du cycle de vie d'un produit au sein d'un laboratoire de contrôle il existe un risque de perte d'intégrité.D'un point de vue pratique, la date limite d'utilisation d'un produit peut être déterminée à travers une approche processus, via l'élaboration d'une étude de risque, ou à travers une approche systématique, via la réalisation d'études de stabilité.L'étude d'un cas concret, sera l'occasion d'expliquer les motivations de la mise en place d'une telle démarche et d'évaluer les méthodologies existantes.
Download or read book La validation analytique dans le contr le des m dicaments et exemples d application written by Laurence Grinie and published by . This book was released on 2006 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: La validation des méthodes analytiques est un concept fondamental au sein des laboratoires de contrôle qualité de l'industrie pharmaceutique. Cette étape est essentielle afin d'une part, de se conformer aux exigences réglementaires, et, d'autre part, dans une approche qualité, de développer la maîtrise des méthodes d'analyse, au quotidien. Les exemples d'application, détaillés dans cette présentation, illustrent le déroulement, la place et l'importance de la validation analytique. La validation, de type initiale, d'une méthode de dosage est entreprise, après la phase de développement, afin de démontrer que cette méthode est réellement adaptée au dosage à réaliser. Les compléments de validation, effectués après évaluation des modifications apportées aux méthodes d'analyse au cours de leur usage, permettent de garantir la pérennité de ces méthodes.
Download or read book Les validations de m thodes d analyses au contr le qualit dans l industrie pharmaceutique written by Gauthier Gaillard and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le sujet de thèse proposé expose les validations de méthodes d'analyses au laboratoire de contrôle qualité, dans l'industrie pharmaceutique, d'un point de vue règlementaire tout d'abord, puis d'un oeil très pratique. Le contexte réglementaire général est mis en place dans la première partie avant de s'intéresser plus précisément aux validations de méthodes microbiologiques dans la deuxième partie. La partie finale expose les travaux de validation effectués dans le laboratoire de Contrôle Qualité de Microbiologie d'Octapharma Lingolsheim. Des revalidations périodiques et des validations de méthodes analytiques entrainées par un changement de méthode sont imposées par les Bonnes Pratiques de Fabrication. Le laboratoire comporte 22 procédures et donc un grand nombre de validations de méthodes sont à mettre en place. Le travail mis en place concerne 3 validations principales : • Validation de la numération de germes par filtration d'échantillons en cours de procédé de fabrication • Validation de la possibilité d'utiliser du milieu de culture fusionné après 8h de maintien au bain-marie • Validation de la possibilité d'incuber les différents milieux de culture jusqu'à leur péremption La rédaction du protocole de validation et de son analyse de risque est suivie par la mise en place de la technique d'analyse puis de la rédaction du rapport de validation. Une fois tous ces documents vérifiés et signés par les différents services en charge, les procédures sont révisées en conséquence.
Download or read book Gestion des appareils au laboratoire de contr le qualit written by Sebastien Monnet and published by . This book was released on 2003 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: La gestion des appareils au laboratoire de Contrôle Qualité décrit toutes les étapes de la vie des appareils, leur traçabilité, ainsi que la gestion globale qui leur est associée. Des rappels bibliographiques résument et situent la notion de qualité industrielle au niveau français et mondial. La notion de qualité pharmaceutique est ensuite abordée. En ce qui concerne la qualité, les grands principes correspondant sont discutés, telles que la gestion documentaire, la définition des responsabilités. Le cycle de vie des appareils est abordé avec notamment les étapes suivantes : de l'apparition du besoin à sa finalisation : cahier des charges et Qualification de Conception ; de la commande à la qualification opérationnelle : Qualification d'Installation et Qualification Opérationnelle ; de la mise en service à la mise hors service : Qualification des Performances, fiche de vie
Download or read book Taking a Multisectoral One Health Approach A Tripartite Guide to Addressing Zoonotic Diseases in Countries written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2019-03-11 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2018 FAO-OIE-WHO (Tripartite) zoonoses guide, “Taking A Multisectoral, One Health Approach: A Tripartite Guide to Addressing Zoonotic Diseases in Countries” (2018 TZG) is being jointly developed to provide member countries with practical guidance on OH approaches to build national mechanisms for multisectoral coordination, communication, and collaboration to address zoonotic disease threats at the animal-human-environment interface. The 2018 TZG updates and expands on the guidance in the one previous jointly-developed, zoonoses-specific guidance document: the 2008 Tripartite “Zoonotic Diseases: A Guide to Establishing Collaboration between Animal and Human Health Sectors at the Country Level”, developed in WHO South-East Asia Region and Western Pacific Region. The 2018 TZG supports building by countries of the resilience and capacity to address emerging and endemic zoonotic diseases such as avian influenza, rabies, Ebola, and Rift Valley fever, as well as food-borne diseases and antimicrobial resistance, and to minimize their impacts on health, livelihoods, and economies. It additionally supports country efforts to implement WHO International Health Regulations (2005) and OIE international standards, to address gaps identified through external and internal health system evaluations, and to achieve targets of the Sustainable Development Goals. The 2018 TZG provides relevant country ministries and agencies with lessons learned and good practices identified from country-level experiences in taking OH approaches for preparedness, prevention, detection and response to zoonotic disease threats, and provides guidance on multisectoral communication, coordination, and collaboration. It informs on regional and country-level OH activities and relevant unisectoral and multisectoral tools available for countries to use.
Download or read book Faecal Sludge Management written by Linda Strande and published by IWA Publishing. This book was released on 2014-08-15 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is estimated that literally billions of residents in urban and peri-urban areas of Africa, Asia, and Latin America are served by onsite sanitation systems (e.g. various types of latrines and septic tanks). Until recently, the management of faecal sludge from these onsite systems has been grossly neglected, partially as a result of them being considered temporary solutions until sewer-based systems could be implemented. However, the perception of onsite or decentralized sanitation technologies for urban areas is gradually changing, and is increasingly being considered as long-term, sustainable options in urban areas, especially in low- and middle-income countries that lack sewer infrastructures. This is the first book dedicated to faecal sludge management. It compiles the current state of knowledge of the rapidly evolving field of faecal sludge management, and presents an integrated approach that includes technology, management, and planning based on Sandecs 20 years of experience in the field. Faecal Sludge Management: Systems Approach for Implementation and Operation addresses the organization of the entire faecal sludge management service chain, from the collection and transport of sludge, and the current state of knowledge of treatment options, to the final end use or disposal of treated sludge. The book also presents important factors to consider when evaluating and upscaling new treatment technology options. The book is designed for undergraduate and graduate students, and engineers and practitioners in the field who have some basic knowledge of environmental and/or wastewater engineering.
Download or read book Pre Examination Procedures in Laboratory Diagnostics written by Walter G. Guder and published by Walter de Gruyter GmbH & Co KG. This book was released on 2015-08-31 with total page 493 pages. Available in PDF, EPUB and Kindle. Book excerpt: The preanalytical phase is an important component of Laboratory medicine and errors arising in this phase affect the validity of laboratory results. In this book physicians and clinical staff have access to valuable information about the current preanalytical variables and factors (patient preparation, sample collection, handling and processing before analysis).
Download or read book Cover Crops in West Africa written by International Development Research Centre (Canada) and published by IDRC. This book was released on 1998 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cover Crops in West Africa Contributing to Sustainable Agriculture
Download or read book Remediation Technologies for Soils and Groundwater written by and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book PASCAL written by and published by . This book was released on 1991 with total page 744 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Soil Analysis written by J. Gautheyrou and published by CRC Press. This book was released on 2001-01-01 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of this book is to provide a better understanding of tools for soil analysis in order to use them more efficiently. It covers sampling problems as well as difficulties relating to actual analysis and quality control.
Download or read book Global Burden of Disease and Risk Factors written by Alan D. Lopez and published by World Bank Publications. This book was released on 2006-04-02 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.
Download or read book Multispecies Approaches to Fisheries Management Advice written by M. C. Mercer and published by . This book was released on 1982 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication comprises the proceedings of an international workshop convened in St. John's, Nfld, Nov. 26-29, 1979. The purpose of the workshop was to discuss the results of recent multispecies research, its applications to management, and to consider future directions for research in this field. A total of 26 papers were presented, including a combination of experience papers, state-of-the-art review, and new scientific findings. Sequential sessions were held on fisheries systems research by the Department of Fisheries and Oceans, multispecies considerations in fisheries research and management advice in the ICES area, species interactions in the Northeast Pacific and Northwest Atlantic, fisheries interactions, and applications to fisheries management. The workshop concluded with a substantial discussion of implications of present knowledge for advice to fisheries managers and implications for research program planning. The Workshop Report comprises the Chairman's opening remarks, a report on main elements of discussion in the sessions, and a summarization of workshop conclusions.
Download or read book Trends in Global Higher Education written by Philip G. Altbach and published by BRILL. This book was released on 2019-04-09 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patterns of globalization, the flow of students and scholars across borders, the impact of information technology, and other key forces are critically assessed. This book is a key resource for understanding the present and future of global higher education.
Download or read book Frontline and Factory written by Roy MacLeod and published by Springer Science & Business Media. This book was released on 2007-05-06 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents a first considered attempt to study the factors that conditioned industrial chemistry for war in 1914-18. Taking a comparative perspective, it reflects on the experience of France, Germany, Austria, Russia, Britain, Italy and Russia, and points to significant similarities and differences. It looks at changing patterns in the organisation of industry, and at the emerging symbiosis between science, industry and the military.
Download or read book Le Golfe Du Saint Laurent petit Oc an Ou Grand Estuaire written by Canada. Department of Fisheries and Oceans and published by Peches Et Oceans Direction Generale Des Communications = Fisheries and Oceans Communications Dir. This book was released on 1991 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proceedings of a workshop, the scientific reviews and the contributed papers presented at the symposium. The document presents a brief historical summary of marine research in the Gulf; reports the discussions, conclusions and recommendations of the different working groups on oceanography (physics, biology, chemistry and sedimentology) and on the fishery (fish and invertebrates); then presents the discussions of each multidisciplinary working group, centered around how the St. Lawrence system may be used as a natural laboratory which will contribute to the solution of major long-term problems of conservation of natural resources and of the quality of the environment.
