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中国兽药生产厂家及产品在非洲的注册要求(中英对照)

Manufacturing Vet Drugs Plant Registration Requirement 生产厂家注册要求:
1-The plant should be G.M.P certificate from the competent authorities in the country of origin (Authenticated G.M.P certificate).生产厂家需有GMP证书并公证
2-The plant should be manufacturing plant not packaging. 应为生产厂家而非包装厂
3- Its products should be freely sold in the country of origin. 产品应在原产国自由销售
4- Statement explaining branches of the plants and defining form and activities of each whether it is manufacturer, packager or distributor.对生产厂家各分公司的说明(是生产、包装还是销售)
5-The following information and should clearly state:清楚说明以下信息:
5-1 -History of foundation and establishment and its subsequent development.
厂家建成和发展的历史
5-2 -List of products and their chemical compositions and concentration.
产品清单及其化学组成和浓度
6-Production lines in the plant should be described in details.详细描述生产线
7- Quality control laboratory. 实验室
8-Technical staff responsible for the following activities:以下内容的负责技术人员的说明
8-1 -Production in different lines.各生产线的生产
8-2 -Quality control lab staff responsible for chemical, Physical analysis and microbiological tests.负责理化实验和微生物实验的质检人员
8-3 -Qualification and experiences of the all technical staff and this should be issued by competent authority and authenticated.所有这些技术人员的资质应有主管部门颁发的证书并公证
9- List of the major machineries and equipment used in both production and quality control. 生产和质量控制部门的主要机械设备清单
10-The sources of water used in the plant for cleaning and production and how it's treated.工厂用来清洁和生产的水源及其处理方法
Vet. Drugs Registration Requirement 兽药注册要求:
1. The authenticated C.P.P (Certificate of pharmaceutical products) 公证的CPP
2. Certificate of analysis.检验报告
3. Method of manufacture.生产流程

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[发布时间:2007-8-14 17:46:32 来源:admin]
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