药品生产

《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 .

浅谈FDA以风险为基础的药品生产检查方法及启示

FDA 's Risk-based Inspections Approach for Pharmaceutical Manufacturers and It 's Enlightenments

药品生产企业GMP文件分类与编码方法探讨

Discussion on the Classifying and Coding Method for GMP Documents

如何看待GMP《药品生产质量管理规范》

How to understand GMP Pharmaceutical manufacturing quality management specifications '

GMP与药品生产的净化要求

GMP and the requirements of pharmaceutical production for air cleaning

结果：说明验证是药品生产中GMP的基石。

Result : validation is the base of GMP in medicine producing .

质量风险管理在药品生产企业GMP实施中的应用

Application of quality risk management in GMP quality system for the manufacturers

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

为了应对仿制药品生产商的竞争，美国和欧盟的药品工业在TRIPS协议谈判中发挥了重要的作用。

Reacting to competition from generic producers , the U.S. and E.U. pharmaceutical industries played a lead role in TRIPS Agreement negotiations .

《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 .

笔者以某药品生产企业新上市的OTC抗感冒药为例进行OTC药品渠道设计。

Taking the OTC anti-common cold drug launched by a pharmaceutical manufacturer as the example to design the OTC medical channel .

HAZOP在药品生产偏差分析中的应用

Application of HAZOP in Pharmaceutical Production Deviations Analysis

作者通过对50家药品生产企业的检查验收，对进一步推行GMP提出几点意见。

After the examination and acceptance of 50 drug manufacturing enterprises , the author introduces her views on further carrying out GMP .

在药厂的GMP认证中，如何优化药品生产环境通常被作为一项重要指标来进行考察。

How to optimize the manufacturing environment of pharmaceutics workshop is an important factor in the course of GMP authentication of pharmaceutical factories .

我国于1988年导入了GMP，并在1999年开始对国内药品生产厂家强制实施GMP规范。

The GMP was introduced into our country in 1988 . After 1998 , the domestic pharmaceutical manufacturer was compelled to implement GMP .

分析了当前药品生产企业GMP认证后存在的管理滑坡问题，有针对性的提出解决办法。

The main cause of the quality of drugs existed in pharmaceutical manufacturer after certification of GMP is analysized , and countermeasures are provided .

自打注射用药品生产开始，人们就认识到在最终容器内很多药物和生物制品无法承受物理灭菌过程。B上单与底单间隙用无菌枕套覆盖。

Since the earliest days of parenteral manufacturing it has been recognized that many drugs and biologics would not withstand a physical sterilization process in their final container . B , Interval between top sheet and foundation drapes covered by sterile pillowcases .

在WD药业集团的状况中描述了运营组织架构、药品生产情况及药品的销售情况。

The introduction of WD Pharmaceutical Group includes the organizational structure of operation , the production and marketing status of drugs .

目的：了解我市各医院及药品生产、经营企业的药品不良反应（ADR）报告情况，探讨发生ADR的因素。

OBJECTIVES : To fathom situation and the cause about adverse drug reactions ( ADR ) from each drug manu ˉ facturing enterprise and drug handling enterprise in our city .

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 .

结果：药品生产企业实施GMP文件管理是GMP认证的一个重要的方面，是防止差错的重要手段。

Results : Actualizing the documents on GMP in pharmaceutical corporation is both an important aspect of the inspection on GMP and important means of avoiding the accidents .

药品生产企业与ISO14001认证

Pharmaceutical Enterprise and ISO 14001

中国在现代医药以及传统医药方面都有很大的市场空间，并且在低成本原料药（activepharmaceuticalingredients）的全球生产与销售中变得越来越重要。原料药是用于药品生产的原材料。

China has a large market for modern as well as traditional medicine , and has become increasingly important in the production and sale globally of low-cost active pharmaceutical ingredients , or the raw materials used in medicines produced elsewhere .

该方法使企业对药品生产的全过程进行信息化的质量管理和控制，搭建了制药企业中结合GMP信息的生产管理模型。

This method helps make the whole production process into digitalized management and control . A production management model can be set up incorporating with GMP in pharmaceutical enterprises .

GMP认证制度是国家对药品生产企业监督检验的一种手段，也是保证药品质量的一种科学、先进的管理方法。

GMP certification system is not only a kind of methods supervising pharmaceutical enterprises in our country , but also scientific and advanced management to guarantee drugs ' quality .

其次，参与药品生产和销售的企业应该受到GMP和GSP的监管。

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

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。

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 .