药品生产质量管理规范

《药品生产质量管理规范》文件的管理我国兽药生产质量管理规范发展概况

Management of Document on GMP The overview of GMP for veterinary drug development in China

《药品生产质量管理规范》认证证书的格式由国务院药品监督管理部门统一规定。

The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State Council .

如何看待GMP《药品生产质量管理规范》

How to understand GMP Pharmaceutical manufacturing quality management specifications '

《药品生产质量管理规范实施指南》充分体现GMP（1998版）的宗旨。

The Guideline of Good Manufacture Practice for Drugs ( as Guideline ) reflects GMP ( Ver . 1998 ) .

前言：目的：为完善我国《药品生产质量管理规范》（GMP）提供参考。

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

GMP（GoodManufacturingPracticesforDrug）《药品生产质量管理规范》又称《良好药品生产实践》，其基本内容是要保证药品质量，必须防止生产中药品的混批、混杂污染和交叉污染。

The fundamental content of GMP ( Good Manufacturing Practices for Drug ) is to ensure drug quality , to prevent the batch confusion , mixed contamination and cross contamination during the drug manufacturing .

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。

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 .

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。

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 ) .

《药品生产质量管理规范》已经成为国际公认的制药企业药品生产和质量管理的基本准则，GMP认证证书已成为药品销售的通行证。

Good Manufacture Practice for Drugs ( GMP ) has been internationally recognized as a basic standard for drug production and quality management , and GMP Compliance Certification is now a passport for pharmaceuticals trading .

我国《药品生产质量管理规范》（GMP）明确指出，要把药品的质量问题消除在生产过程中，这对药品生产过程的质量控制技术提出了更高的要求。

The Good manufacture practice ( GMP ) clearly points out that the quality problems of the drugs had to be eliminated in the production process , and it requires improving the quality control skills in the drug production process .

通过《药品生产质量管理规范》认证，是国家对制药企业的法规性要求。

It is a legal requirement of the state for pharmaceutical enterprises to qualify GMP authentication .

制备过程应当严格执行《药品生产质量管理规范》的要求。

The process of production and preparation shall strictly follow the Criterions for the Quality Control of Drug Manufacturing .

GMP是医药行业对药品生产质量管理的规范，质量管理和质量保证系列标准（简称ISO9000系列）是国际上物品生产通用的质量管理和质量保证的规范。

GMP is the standard for quality control in drug production . Quality control and quality assurance serial standard ( ISO9000 ) is in common use in the world as the standard of manufacture of products .

出现药品安全事故的企业不乏通过《药品生产质量管理规范》（GMP）的企业，药品监管高层人员的相继落马，无不暴露了我国药品监管中存在的漏洞。

Drug safety incidents occur there is no lack of enterprise through the " Good Manufacturing Practices " ( GMP ) of the enterprise , drug regulators have been sacked senior staff , which all exposed in our drug regulatory loopholes .

药品生产经营主管部门可以根据《药品生产质量管理规范》的要求，制定实施规划，指导《药品生产质量管理规范》的逐步实施。

The departments in charge of the production and trading of medicines may formulate specific rules to guide the gradual implementation of the norms .

前言：目的：药品生产企业一切生产活动应以《药品生产质量管理规范》文件为根据。

Objective : All productive activities in pharmaceutical corporation should be based on documents on GMP .

药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证；对认证合格的，发给认证证书。

The drug regulatory agency shall inspect a drug manufacturer as to its compliance with the GMP requirements and issue a certificate to the manufacturer passing the inspection .