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首页> 外文会议>International Conference of the Australian Centre for International Agricultural Research >Managing the risks to vaccine quality associated with the small-scale production of 1-2 Newcastle disease vaccine in developing countries
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Managing the risks to vaccine quality associated with the small-scale production of 1-2 Newcastle disease vaccine in developing countries

机译：管理与发展中国家1-2个新城疫疫苗的小规模生产相关的疫苗质量的风险

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Manufacturers in developing countries involved in the small-scale production of 1-2 Newcastle disease (ND) vaccine for use in village chickens face many challenges that can affect vaccine quality. At the laboratory level these include problems in obtaining quality consumables, ensuring reliable and regular supplies of water and electricity, mamtaining vital equipment, retaining trained and motivated personnel, and providing an appropriate production environment. Vaccine packaging and distribution inthe field can also present problems. Regulatory authorities in many developing countries have developed good manufacturing practice (GMP) standards to ensure the quality of imported and locally produced pharmaceutical products and vaccines. However, in many cases, local small-scale producers of veterinary vaccines will have some difficulty in meeting these standards. Quality assurance managers must therefore adopt a risk-based approach to GMP and establish controls and procedures that ensure productionand distribution of a product of acceptable quality at an affordable price for use in control of ND in village chickens. One such approach drafted by the quality assurance managers of the Southern Africa Newcastle Disease Control Project participating countries is discussed.
机译：发展中国家的制造商参与了1-2岁的小规模生产（ND）疫苗，用于村鸡面临许多可能影响疫苗质量的挑战。在实验室级别，这些内容包括获得质量耗材的问题，确保可靠和定期的水和电源供应，Mamtaining Vital设备，保留培训和有动力的人员，并提供适当的生产环境。疫苗包装和分配Inthe现场也可以存在问题。许多发展中国家的监管机构都制定了良好的制造业实践（GMP）标准，以确保进口和本地制作药品和疫苗的质量。然而，在许多情况下，兽医疫苗的当地小规模生产者将在满足这些标准方面存在一些困难。因此，质量保证管理人员必须采用基于风险的基于GMP的方法，并建立控制和程序，以确保以可负担的价格生产可接受质量的产品，以控制村鸡的ND。讨论了南非南部非洲南部非洲疾病控制项目参与国家的质量保证管理人员起草的一种这样的方法。

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