药品生产管理

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 .

《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 .

目的：为药品生产企业管理销售人员提供参考。

OBJECTIVE : To provide the reference for the management of salesmen for pharmaceutical manufacture enterprises .

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 .

目的：为我国药品生产质量管理的改进提供借鉴。

OBJECTIVE : To provide references for the improvement of the Good Manufacturing Practices ( GMP ) of drugs .

《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 .

近年来，一些国家或地区已逐步将风险管理应用于药品生产监督管理工作中，尤其是美国和欧盟，已制定并出台了相关文件来指导药品生产风险管理工作。

Especially in the United States and the European Union , the relevant documents have been developed and introduced to guide the work of risk management in pharmaceutical production .

论药品生产企业质量管理标准问题

On the Criterion of Quality Management in Pharmaceutical Enterprises

因此，制药企业作为高新技术产业，运用高新技术成果，采取现代化管理手段，实现对药品生产质量的管理和监督，已成为有识之士的共识。

Therefore , the pharmaceutical industry as a high-tech industry , using high-tech achievements , adopt modern management tools , to realize the quality of pharmaceutical production management and supervision , has become the consensus of people of insight .

通过分析设备管理的现状，阐述我国药品生产企业设备管理所面临的挑战、制药设备管理系统所要解决的问题，以及我国制药企业构建制药设备管理系统的背景和意义。

Based on the analysis of the current situation of equipment administration , the challenge faced by the pharmaceutical enterprises in China in the respect of equipment administration , the problems existed in pharmaceutical equipment administration system and the significance of equipment administration system were stated .

药品生产企业的设备管理很大程度上决定了药品生产的质量。

The quality of medicine produced is , to a great extent , determined by equipment administration .

简要介绍了中国放射性药品研制、生产和管理的发展历史及其现状。

The history and present situation of the research and development , production and administration of radiopharmaceuticals in China are briefly introduced .

文章介绍了如何用数据库系统实现对药品生产批记录的管理，并实现对药品生产的质量追踪。

This paper introduces how to realize the management of batch records and the pursuit of quality in drug production by the database system .

政府对医药卫生事业的管理效果不佳，从整个卫生服务体系到医疗服务，到药品生产经营，政府管理的效果越来越差。

The administrative effect of the medical care and public health is not good . The whole health service system , including medical service and medicines , the administrative effect is worse and worse . 4 .

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

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

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 .

在药品安全监督管理的全过程中，对药品生产企业质量管理体系的监管，是针对药品行业产业链最前端的管理模式，也是最根本的监管方式。

Supervision and management on the quality management system of pharmaceutical manufacturer is not only a management model for the starting point of the industry chain of the pharmaceutical industry , but also the most fundamental form of regulation .

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 .