GOOD MANUFACTURING PRACTICE

OBJECTIVE : To provide references for the improvement of our country 's current Good Manufacturing Practice ( GMP ) .

前言：目的：为完善我国《药品生产质量管理规范》（GMP）提供参考。

This study explored the economy-law effects of the good manufacturing practice ( GMP ) for drugs in China and presented the limitation of GMP as economic law .

文章从经济法的视角对我国近年来逐步推行的药品生产质量管理规范（GMP）认证制度进行评析，指出其本身具备的经济法性质，分析其作为一项经济法律手段所存在的问题。

The Implementing Effect of Good Manufacturing Practice in Milk Production

原料奶生产良好卫生规范（GMP）的实施效果

To perfect administration of Good Manufacturing Practice and make it implement ;

健全和完善药品GMP监管制度并切实履行；

Production of stem-cell transplants according to good manufacturing practice

按照优质生产程序制备干细胞移植物

The FDA cited violations to good manufacturing practice .

FDA引证兰伯西违反了良好生产规范。

Study on the Economy-law Effects of the Good Manufacturing Practice ( GMP ) for Drugs in China

对我国药品GMP认证的经济法思考

GMP is good manufacturing practice system to prove the safety of production of medicine and food , is a independent manufacturing system .

GMP（良好操作规范）是保证药品、食品具有高度安全性的良好生产管理体系，是一种自主性管理制度。

The agency rapidly set up mechanisms to ensure adherence to drug standards , including enforcing good manufacturing practice and centralising drug approvals .

药监局也迅速地建立了一整套机制来确保药品质量，这包括强制推行GMP认证和废除地方药物标准，统一药物审批权。

He introduced a Chinese version of Good Manufacturing Practice guidelines , which ensure that production is up to standard and that a mechanism is in place to deal with drug problems .

他组织起草了GMP指南的中国版，使得药品生产符合规范，并引入一套机制来处理药品问题。

In order to monitor the implementation of good manufacturing practice , any necessary corrective measures and regular internal audits are performed in accordance with an approved schedule .

为了监控GMP的执行情况，应根据批准的时间表执行任何必要的纠正措施以及定期的内部审计。

Secondly , the enterprises engaged in drug manufacture and trade should be regulated by the Good Manufacturing Practice ( GMP ) and Good Selling Practice ( GSP ) .

其次，参与药品生产和销售的企业应该受到GMP和GSP的监管。

American Drug Manufacturing Science and Its Implication for Good Manufacturing Practice of Drugs in China ; Discussion On the Management of Deviations in the Process of the Pharmaceutical Production by the Pharmaceutical Manufacturers

美国药品生产科学及对我国药品生产质量管理的启示浅谈药品生产企业在药品生产过程中的偏差管理

The first quality concern of a biopharmaceutical product is its safety and efficacy . Thus requires that the whole production procedures must comply with the requirements of Good Manufacturing Practice ( GMP ) .

生物制药产品的质量首先是要安全有效，生产过程必须遵守药品生产质量管理规范GMP质量管理的要求。

Good Manufacturing Practice ( GMP ) regulates the regulatory sanitation requirements of the producing , manufacturing , packaging , storing , transporting and selling of food . It is the basis of HACCP .

良好生产规范（GoodManufacturingpractice）的简称GMP，它规定了食品生产、加工、包装、贮存、运输和销售的规范性卫生要求，是HACCP建立实施的基础。

This paper expounds the developing situation of drug 's GMP ( Good Manufacturing Practice ) and the necessity of Chinese pharmaceutical enterprises ' carrying out GMP , and puts forward some measures of doing well the implement and attestation of GMP .

阐述了药品GMP（GoodManufacturingpractice）的发展状况及我国制药企业实施GMP的必要性，提出了制药企业做好GMP实施和认证工作的措施。