首页 ICH

ICH

举报
开通vip

ICHICH(人用药物注册技术要求国际协调会议,International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)是美国、欧盟和日本三个国家在1990年联合发起滴  ICH(人用药物注册技术要求国际协调会议,International Conference on Harmonization of Technical Requirements for Re...

ICH
ICH(人用药物注册技术要求国际协调会议,International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)是美国、欧盟和日本三个国家在1990年联合发起滴  ICH(人用药物注册技术要求国际协调会议,International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)是美国、欧盟和日本三个国家在1990年联合发起滴。主要因为地球上国家太多,不同国家对药品的注册要求都不一样,造成一系列的技术交流和贸易困难,其中的主要被害人美、日、欧被逼无奈,最终就发起了这样一个国际性的共同协商会议,取的名字还非常之绕口令。我K……     ICH文件分为“Q、S、E、M”四大类,分别是QUALITY、SAFETY、EFFICACY和MULTIDISCIPLINARY。所以ICHQ7a的Q就代表——质量。7是Q下面的继续小分类,代表的是GMP,其它的数字,例如1就表示稳定性、2表示方法学啦等等等等。那a呢,其实就是Active Pharmaceutical Ingredients的超级缩写,中文直译就指药物活性成分,其实一般就指原料药啦。     由于在药界呢,美日欧势力滔天,故而它们几家制定的Q7就成了地球水平,完全把我们的GMP踏在了脚下,生生逼迫我国人民卧薪尝胆、奋发图强、爱我中华。主席说的好,一切反动派都是纸老虎!所以我们更要认真研究之,借鉴之,超越之,期待有朝一日反踩之!虽然貌似很难,很难…… TBC※ Q1A(R2) Stability Testing of New Drug Substances and Products Q1B Stability Testing : Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1E Evaluation of Stability Data Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV Q2(R1) New title: Validation of Analytical Procedures: Text and Methodology Q3A(R2) Impurities in New Drug Substances Q3B(R2) Impurities in New Drug Products Q3C(R3) Impurities: Guideline for Residual Solvents Q4 Pharmacopoeias Q4A Pharmacopoeial Harmonisation Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B Annex 1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter Q4B Annex 2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter Q4B Annex 3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter Q4B Annex 4A Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Q4B Annex 4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Q4B Annex 4C Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Q4B Annex 5 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5B Quality of Biotechnological Products : Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5C Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including Decision Trees) Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7A Q8 Pharmaceutical Development Annex to Q8 Pharmaceutical Development Annex Q9 Quality Risk Management Pharmaceutical Quality System Q10 Pharmaceutical Quality System
本文档为【ICH】,请使用软件OFFICE或WPS软件打开。作品中的文字与图均可以修改和编辑, 图片更改请在作品中右键图片并更换,文字修改请直接点击文字进行修改,也可以新增和删除文档中的内容。
该文档来自用户分享,如有侵权行为请发邮件ishare@vip.sina.com联系网站客服,我们会及时删除。
[版权声明] 本站所有资料为用户分享产生,若发现您的权利被侵害,请联系客服邮件isharekefu@iask.cn,我们尽快处理。
本作品所展示的图片、画像、字体、音乐的版权可能需版权方额外授权,请谨慎使用。
网站提供的党政主题相关内容(国旗、国徽、党徽..)目的在于配合国家政策宣传,仅限个人学习分享使用,禁止用于任何广告和商用目的。
下载需要: 免费 已有0 人下载
最新资料
资料动态
专题动态
is_622105
暂无简介~
格式:doc
大小:28KB
软件:Word
页数:2
分类:
上传时间:2011-06-27
浏览量:90