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gmp regulations
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  “gmp regulations”译为未确定词的双语例句
     This article also put forward establishing GMP regulations of phytosanitary and practicing integrated control management for phytosanitary risk using these measures such as CCP, products classification management etc.
     提出了建立植物检疫的GMP制度,利用CCP风险过程控制与产品分级分类管理等措施对检疫风险实行综合控制的策略。
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  相似匹配句对
     Profile on GMP
     浅谈对GMP的认识
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     Interpretation of Regulations
     解读《规程》
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     On Justice and Regulations
     论公正与规则
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     I. GMP Snooping;
     IGMP Snooping组播管理;
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  gmp regulations
GMP regulations apply to all phases of cell collection, processing, and storage, and to documentation, training of personnel, and equipment of the cell processing laboratory.
      
The contractor is fully accountable to follow the appropriate predicate rules, in this case, the GMP regulations.
      
GMP regulations require a quality approach to manufacturing, in order to eliminate mistakes and contamination.
      
A general outline of GMP regulations is presented in Table 3.
      


Good manufacturing practices(GMP) regulations have won the approval of food manufacturers worldwide.It serves to assure that all food is safe and has been prepared,packed and held under sanitary conditions.The main requirements that should be established in GMP of UHT plant are discussed in this paper.

良好生产规范(GoodManufacturingPractice,GMP),是国际上普遍采用的食品生产先进管理方法,它是在食品生产全过程中保证食品具有高度安全性的良好生产管理系统。文章列举了超高温奶生产的GMP中的主要内容。

To investigate and evaluate the feasibility and validity of HACCP system for its application in production of probiotic capsules. Continuous investigation for microbial indices on personnel,equipments,environments,raw materials,semi-finished goods and final products,as well as the hazard analysis on raw materials and processing technology in a model factory,were carried out under the instruction of "HACCP system and guideline for its application"(CAC regulation) and the requirements of GMP regulation...

To investigate and evaluate the feasibility and validity of HACCP system for its application in production of probiotic capsules. Continuous investigation for microbial indices on personnel,equipments,environments,raw materials,semi-finished goods and final products,as well as the hazard analysis on raw materials and processing technology in a model factory,were carried out under the instruction of "HACCP system and guideline for its application"(CAC regulation) and the requirements of GMP regulation for medicine manufacture as well as Health Food GMP regulation. Critical control indices on probiotic strains,pipeline sterilization before fermentation and centrifuge,material transportation,etc,were established.The control criterion of both microbiological hygiene and safety/risk assessment for probiotic production were proposed. [Conclusion] HACCP system was established and applied to the production lines of probiotic capsules;its feasibility and validity were proved in model factory.

[目的 ]在益生菌保健食品生产领域建立危害分析与关键控制点 (HACCP)系统 ,并验证其可行性和有效性。[方法 ]参照国际食品法典委员会文件《HACCP的原理及其应用准则》推荐的原理和程序及国家保健食品良好操作规范(GMP)法规和药品良好操作规范 (GMP)法规的要求 ,通过对人员、设备、环境、原料、半成品、成品等对象的微生物卫生指标进行一系列检测 ,并对所有原料和加工工艺进行危害分析 ,建立胶囊型益生菌保健食品HACCP体系。 [结果 ]确定了菌种的使用和控制、发酵前灭菌、离心机管道和物料管道的灭菌、充填前的辅料烘料、半成品金属探测为关键控制点 ,制定出一套详细的HACCP计划。经试运行 ,主要危害得到控制。 [结论 ]该研究确立的HACCP系统可为胶囊型益生菌保健食品的安全卫生控制提供科学依据

As medical devices' manufacture and Pharmaceuticals' manufacture have their own specific characteristics, thepharmaceutical manufacturers, at present, are forced to carry out pharmaceutical GMP while medical devices' GMP has not yet been drawn up . This article .based on the analysis and the comparison between GMP regulation and ISO9001 Standard , intends to point out their differences and to explain why the medical device industry can not simply take ISO9001-based ISO 13485 as its GMP....

As medical devices' manufacture and Pharmaceuticals' manufacture have their own specific characteristics, thepharmaceutical manufacturers, at present, are forced to carry out pharmaceutical GMP while medical devices' GMP has not yet been drawn up . This article .based on the analysis and the comparison between GMP regulation and ISO9001 Standard , intends to point out their differences and to explain why the medical device industry can not simply take ISO9001-based ISO 13485 as its GMP. Besides, this article presents some suggestions and tentative ideas in regard to working out Chinese Medical Device GMP and to establishing its legal status in China.

医疗器械和药品的生产各有其特殊性。药品生产企业目前执行"药品生产质量管理规范"(GMP),用于医疗器械生产企业的GMP尚未问世。通过对比分析药品GMP和国际通用质量管理体系标准ISO9001,指出不能将基于ISO9001的ISO13485简单转为医疗器械的GMP;并对如何制定我国的医疗器械GMP提出一些设想,对确定医疗器械GMP的法律地位等方面也提出一些看法。

 
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