药品质量管理

应用TQC方法加强医院药房的药品质量管理

Application of TQC Method to Strengthen the Drug Quality Control in Hospital Pharmacy

GMP是国家发布的强制性药品质量管理规范，BPR是目前比较前沿的管理理论。

GMP is a forceful system of criterion set up by the country to guide the quality of medicine , while BPR is an advanced management theory at present .

目的：探讨制订医疗机构药品质量管理规范。

OBJECTIVE : To discuss drug quality management practice in medical institutions .

欧洲药品质量管理局及欧洲药典简介

Brief Introduction of European Directorate for the Quality Control of Medicines and European Pharmacopoeia

试论医院药品质量管理

Discussion on Drug Quality Control in Hospital

药品质量管理方面所存在的问题越来越突出，由此所引起的后果也越来越严重1-5。

Pharmaceutical quality management , the problems become increasingly prominent , and the resulting consequences are more serious .

结论：制订医疗机构药品质量管理规范对保证药品安全、有效、经济的使用具有重要的作用。

CONSLUSION : The formulation of drug quality management practice in medical institutions is essential in the efforts to ensure safety , effectiveness and economy of drug use .

结果：医疗机构药品质量管理应针对药品供应和使用两个环节分别制订管理制度、操作规范和记录等。

RESULTS : The management system , operation criteria , record system should be formulated respectively in drug quality management of medical institutions aimed directly at drug supply and drug use .

截至2016年5月，已有66种中草药进入欧洲药典。欧洲药典是欧洲药品质量管理的权威指导文献。

As of May this year , 66 Chinese medicinal herbs have been added to the European Pharmacopoeia ( EP ) , an authoritative reference work for quality control of medication in Europe .

前言：目的了解通过《药品经营质量管理规范》（GSP）认证后药品经营企业的现状。

OBJECTIVE : To study the status quo of the drug handling enterprises that passed GSP authentication .

如何看待GMP《药品生产质量管理规范》

How to understand GMP Pharmaceutical manufacturing quality management specifications '

澳大利亚GMP介绍和对药品生产质量管理的缺陷分析

Introduction of GMP in Australia and Analysis of Defects in Quality Administration of Medicine Production

《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 .

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 .

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 .

建设药品监督质量管理系统就成了一个重要任务。

Drug construction quality management system has become an important task .

浅谈规范药品质量标准管理的体会

Discussion about the Understandings of the Control over the Drug Standards

药品质量风险管理中超趋势数据的处理

Management of Out of Trend Data in Drug Quality Risk Management

以农村基层为重点切实加强药品质量监督管理

Strengthening Drug Quality Management with Stress Laid on the Rural Units

推行WHO推荐的化学药物基础测试方法加强基层药品质量监督管理

Carrying Out Basic Testing Method for the Chemical Drugs Recommended by WHO and

医院药品采购质量管理中供方评价方法

Evaluation Method of Supply Side among Quality Management of Drug Stock in Hospital

这个模型也给出了药品开发质量管理的一种基本做法。

This model gives a basic method for the quality management of drug exploiture .

《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

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 .

从而展开对药品质量检验管理系统的开发与设计。

The qualification test spreading out thereby to medicines and chemical reagents manages systematic exploitation and designs that .