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[交流]
【求助】制药企业的Q1a到Q10都代表什么？
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最近刚去一家制药企业，不知道Q1a到Q10都代表什么？ 有虫子知道的吗？谢谢 |
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小木虫(金币+0.5):给个红包，谢谢回帖交流
小木虫(金币+0.5):给个红包，谢谢回帖交流
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最近刚整理： ICH(国际协调会议)由美国、日本和欧盟三方的政府药品注册部门和制药行业在1990年发起。 ICH的专题共分四个类别： 安全性（safety，包括药理、毒理、药代等试验），以“S”表示； 质量（Quality，包括稳定性、验证、杂志、规格等），以“Q”表示； 有效性（Efficacy，包括临床试验中的设计、研究报告、GCP等），以“E”表示； 综合学科（Multidisciplinary，包括术语、管理通讯等），以“M”表示。 ICH质量的技术要求文件Q1-Q10：Q1 稳定性、Q2 方法学、Q3 杂质、Q4 药典、Q5 生物技术、Q6 指标参数、Q7 原料药的GMP、Q8 制药研发、Q9 质量风险管理、Q10 制药质量体系。 |
18楼2009-08-18 10:41:25
cpugoodboy
至尊木虫 (著名写手)
真的醉了不会抽烟
- 应助: 0 (幼儿园)
- 金币: 11959.2
- 散金: 64
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- 沙发: 226
- 帖子: 2986
- 在线: 153.4小时
- 虫号: 289962
- 注册: 2006-10-28
- 性别: GG
- 专业: 制造系统与自动化
2楼2009-07-24 07:22:18
llb1978
金虫 (正式写手)
- 应助: 2 (幼儿园)
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- 帖子: 462
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- 虫号: 92998
- 注册: 2005-09-12
- 性别: GG
- 专业: 药物学
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李金平(金币+1):谢谢参与
李金平(金币+1):谢谢参与
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http://www.ich.org/cache/compo/276-254-1.html Stability 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 Analytical Validation Q2(R1) New title: Validation of Analytical Procedures: Text and Methodology Previously: Text on Validation of Analytical Procedures Q2A Validation of Analytical Procedures: Methodology (in Q2(R1)) Q2B Impurities Q3A(R2) Impurities in New Drug Substances Q3A(R) Q3B(R2) Impurities in New Drug Products Q3B(R) Q3C(R4) Impurities: Guideline for Residual Solvents Q3C Impurities: Guideline for Residual Solvents (Maintenance) PDE for Tetrahydrofuran (in Q3C(R3)) Q3C(M) PDE for N-Methylpyrrolidone (in Q3C(R3)) Q3C(M) Procedures are described here Pharmacopoeias 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 Q4B Annex 6 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Q4B Annex 7 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter Q4B Annex 8 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Sterility General Chapter Q4B Annex 9 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter Q4B Annex 10 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacramyde Gel Electrophoresis General Chapter Quality of Biotechnological Products Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A 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 Specifications 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 Good Manufacturing Practice Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7A Pharmaceutical Development Q8(R1) Pharmaceutical Development Quality Risk Management Q9 Quality Risk Management Pharmaceutical Quality System Q10 Pharmaceutical Quality System Q8/9/10 Q&As Q8/Q9/Q10 - Questions & Answers document |
3楼2009-07-24 07:23:59
reallove2935
禁言 (著名写手)
★
李金平(金币+1):谢谢参与
李金平(金币+1):谢谢参与
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5楼2009-07-24 07:26:39