Search


Current filters:
New search
Add filters

Refine your search


Results 1-10 of 117.
Item hits:
Thumbnail
Comité OMS d' experts de la standardisation biologique [réuni à Genève du 12 au 19 octobre 1993] : quarante-quatrième rapport
WHO Expert Committee on Biological Standardization; World Health Organization ( 1994 )
Abstract

La première partie fournit des renseignements sur l'état actuel et la mise au point de substances de référence pour divers anticorps, antigènes, produits sanguins, cytokines, substances endocriniennes. La deuxième partie du rapport, la plus longue, intéresse plus particulièrement les fabricants et les autorités nationales. Elle contient trois séries de normes : Normes relatives au vaccin antivaricelleux (vivant). Normes relatives au vaccin anti-fièvre hémorragique avec syndrome rénal (inactivé). Normes pour les substances biologiques. Normes relatives aux vaccins antirougeoleux, antiourlien et antirubéolique et aux vaccins associés (vivants)

Thumbnail
WHO Expert Committee on Biological Standardization [meeting held in Geneva from 12 to 19 October 1993] : forty-fourth report
WHO Expert Committee on Biological Standardization; World Health Organization ( 1994 )
Abstract

Reports the work of an expert committee commissioned to identify and establish international standards and reference reagents for biological substances. Held and distributed by WHO International Laboratories for Biological Standards, these reference materials are widely used by national control authorities and manufacturers to ensure worldwide uniformity when designating the potency, activity, or specificity of biologicals used in prophylaxis, therapy or diagnosis of disease. The committee also issues guidelines and detailed requirements for the manufacturing and quality control of selected biologicals. The report has two parts. The first part briefly considers general issues affecting the committee s work, explains the decision to issue new or revised requirements for two vaccines, and reviews the need to establish, replace, or discontinue some 55 international reference materials. Ten new or replacement reference materials were established. The second and most extensive part issues detailed requirements for the manufacturing and quality control of two vaccines. Revised requirements were issued for live varicella vaccine. Revisions reflect the extensive experience gained by manufacturers since the initial requirements were established in 1984. The committee also issued new requirements for inactivated vaccine against haemorrhagic feverwith renal syndrome, an acute interstitial nephropathy caused by viruses belonging to the Hantavirus genus of the family Bunyaviridae

Comité de Expertos de la OMS en Patrones Biológicos [se reunió en Ginebra del 22 al 29 de octubre 1991] : 42o informe
WHO Expert Committee on Biological Standardization; World Health Organization ( 1992 )
Abstract

En la parte principal del informe se presentan tres series de pautas detalladas, destinadas a servir de ayuda a los fabricantes y a los servicios nacionales de inspección en su tarea de asegurar que las vacunas y otros productos biológicos sean inocuos y eficaces. Las pautas dan respuesta a varios problemas específicos de inspección de la calidad que surgen siempre que se emplean procesos y materiales biolâogicos, tales como cultivos de câelulas o extracción de material de los organismos vivos, para fabricar productos farmacéuticos. Asimismo, las recomendaciones y los requisitos responden a recientes y sorprendentes avances de las técnicas de fabricaciâon. Prâacticas adecuadas para la fabricación de productos biológicos. Estas pautas señalan las prácticas adecuadas de fabricación en lo relativo a personal, instalaciones y equipos, alojamiento y cuidado de animales, producción, etiquetado, registros de la producción de los lotes y de la distribución, y garantía e inspección de la calidad. Pautas para los servicios nacionales de control sobre garantía de la calidad de los productos biológicos. Estas pautas indican las medidas que deben adoptar los servicios nacionales de inspección y los laboratorios nacionales de control para asegurar la inocuidad y eficacia de los productos biológicos. Pautas para asegurar la calidad de los anticuerpos monoclonales de uso médico. En la tercera serie de pautas se establecen los requisitos para garantizar la calidad de los anticuerpos monoclonales humanos y murinos de uso médico, incluidos el diagnóstico in vivo y el tratamiento ex vivo. En las pautas, que constan de dos partes - la primera destinada a los fabricantes y la segunda a los servicios nacionales de inspección -, se ponen de relieve las estrictas precauciones necesarias para prevenir la contaminación microbiana, especialmente por virus. Normas para las pruebas de sensibilidad a los antimicrobianos: 1. Pruebas de difusión en agar con discos para determinar la sensibilidad a los antimicrobianos (addéndum de 1991). Laboratorios aprobados por la OMS para la producción de vacuna antiamarílica

Thumbnail
Comité OMS d' experts de la standardisation biologique [réuni à Genève du 22 au 29 octobre 1991] : quarante-deuxième rapport
WHO Expert Committee on Biological Standardization; World Health Organization ( 1992 )
Abstract

Cet ouvrage est le fruit des travaux d'un comité d'experts chargé de coordonner un ensemble de recherches et autres activités nécessaires pour garantir la conformité des produits biologiques aux étalons internationaux de pureté, d'activité, d'innocuité et de stabilité

Thumbnail
WHO Expert Committee on Biological Standardization [meeting held in Geneva from 22 to 29 October 1991] : forty-second report
WHO Expert Committee on Biological Standardization ( 1992 )
Abstract

Presents three sets of detailed guidelines intended to assist manufacturers and national control authorities in their efforts to assure that vaccines and other biological products are safe and efficacious. The guidelines respond to several specific problems of quality control that arise whenever biological processes and materials, such as cultivation of cells or extraction of material from living organisms, are used to manufacture pharmaceutical products. The first guidelines, which cover good manufacturing practices specific to biological products, are intended to supplement the more general guidelines on "Good manufacturing practices for pharmaceutical products", also issued by WHO in 1992 (see below). Because tests of the final biological product can fail to detect certain deficiencies and therefore cannot alone guarantee quality, the guidelines concentrate on the strict in-process controls that must be adhered to at each stage of production, beginning with the production of active ingredients. The second guidelines describe the measures that should be taken by national control authorities and national control laboratories toassure the safety and efficacy of biological products. The third guidelines set out requirements for assuring the quality of murine and human monoclonal antibodies for use in humans, including in vivo diagnosis and ex vivo treatment. Presented in two parts, with the first addressed to manufacturers and the second to national control authorities, the guidelines emphasize the strict precautions needed to prevent microbial contamination, especially by viruses. Each section includes requirements, which may be used as definitive national requirements, and comments and recommendations for guidance. Other sections provide an updated, complete list of codes for antimicrobic susceptibility discs and a list of laboratories approved by WHO for the production of yellow fever vaccine. The report also issues updated information on changes in the status of international reference materials, which are held and distributed by four main international laboratories for use in the standardization and control of biologicals

Comité de Expertos de la OMS en Patrones Biol'ogicos [se reuni'o en Ginebra del 16 al 23 de octubre de 1990] : 41 i̜nforme
WHO Expert Committee on Biological Standardization; World Health Organization ( 1991 )
Thumbnail
WHO Expert Committee on Biological Standardization [meeting held in Geneva from 16-23 October 1990] : forty-first report
WHO Expert Committee on Biological Standardization; World Health Organization ( 1991 )
Abstract

Records the deliberations and recommendations of an expert committee commissioned by WHO to coordinate a range of research and other activities needed to ensure that biological products conform to international standards of purity, potency, safety, and stability. Addressed to manufacturers, researchers and national control authorities, the report also provides updated information about the availability of international biological standards and reference reagents, which are established by WHO and held and distributed by the four international laboratories for biological standards. The report has three main parts. The first consists of brief comments on a number of topics relevant to the development of international reference materials and the use of different assays in quality control. Topics covered include the need to develop international reference materials for growth factors and cytokines, the urgent need to standardize and improve the reliability of assays for residual DNA, and recommended methods for determining the potency of diphtheria toxoid, antivenoms, oral poliomyelitis vaccine, and live measles vaccine. The second part announces changes in the status of international reference materials for various antibiotics, antibodies, antigens, blood products, endocrinological substances and cytokines. The third and most extensive part includes detailed requirements for the manufacturing and licensing of Haemophilus type b conjugate vaccines and inactivated influenza vaccine. Requirements are intended to help manufacturers and control authorities ensure that these products are safe, reliable, and potent prophylactic or therapeutic agents. The book also establishes guidelines for the quality assurance of pharmaceutical and biological products made using recombinant DNA techniques

Thumbnail
Comité OMS d' experts de la standardisation biologique [réuni à Genève du 16 au 23 octobre 1990] : quarante et unième rapport
WHO Expert Committee on Biological Standardization; World Health Organization ( 1991 )
Abstract

Cet ouvrage présente les débats et recommandations d'un comité d'experts chargé par l'OMS de coordonner diverses activités entreprises dans le domaine de la recherche et d'autres domaines en vue de garantir la conformité des produits biologiques avec les normes internationales de pureté, d'activité, d'innocuité et de stabilité. Ce rapport qui s'adresse en particulier aux fabricants, aux chercheurs et aux autorités nationales de contrôle contient en outre des informations mises à jour relatives aux étalons biologiques internationaux et réactifs biologiques internationaux de référence qui ont été mis au point par l'OMS et sont distribués par les quatre laboratoires internationaux d'étalons biologiques

Thumbnail
Comité de Expertos de la OMS en Patrones Biol'ogicos [se reuni'o en Ginebra del 24 al 31 de octubre de 1989] : 40 informe
WHO Expert Committee on Biological Standardization; World Health Organization ( 1990 )
Abstract

Este informe comienza con un análisis de cuestiones generales planteadas al Comité y presenta información sobre la situación y la producción de materiales internacionales de referencia relacionados con diversos antibióticos, anticuerpos, antígenos, productos sanguíneos, sustancias endocrinológicas, citocinas, alergenos y otras sustancias biológicas

Thumbnail
WHO Expert Committee on Biological Standardization [meeting held in Geneva from 24 to 31 October 1989] : fortieth report
WHO Expert Committee on Biological Standardization; World Health Organization ( 1990 )
Abstract

Reports the work of an expert committee commissioned to coordinate the international activities needed to assure the production of safe, potent, and stable prophylatic and therapeutic agents. Work includes the establishment and monitoring of international standard reference materials, in line with changing patterns of clinical use, and the recommendation of requirements to e fulfilled by individual preparations in order to assure their quality and effectiveness. The publication of recommended requirements and advice on the status of international reference materials is intended to facilitate the exchange of biological substances between different countries and to provide guidance to manufacturers, national licensing and control authorities, and others who may have to decide upon appropriate methods of assay and control. The most extensive part of the report issues revised requirements for the manufacturing and control of poliomyelitis vaccine and for diphtheria, tetanus, pertussis, and combined vaccines. The revised requirements for diphtheria, tetanus, pertussis, and combined vaccines place special emphasis on methods of determining the potency of vaccines that would require a smaller number of animals and, for combined vaccines, on the further tests required after blending. The report also sets out detailed procedures to be followed in the preparation, characterization, and establishment of international biological reference materials, including guidelines that can assist national control authorities and individual laboratories in the preparation and establishment of national or laboratory working standards