编号 | 阶段 | 发布日期 | 内容 |
Q1 Stability (稳定性) |
Q1A(R2) | Step 5 | 2003-2-6 | Stability Testing of New Drug Substances and Products |
新原料药和制剂的稳定性试验 |
Q1B | Step 5 | 1996-11-6 | Stability Testing : Photostability Testing of New Drug Substances and Products |
稳定性试验:新原料药和制剂的光稳定性试验 |
Q1C | Step 5 | 1996-11-6 | Stability Testing for New Dosage Forms |
[url=]稳定性试验:新剂型的要求 |
Q1D | Step 5 | 2002-2-7 | Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products |
新原料药和制剂稳定性试验的括号法和矩阵法设计 |
Q1E | Step 5 | 2003-2-6 | Evaluation of Stability Data[/url] |
稳定性数据的评价[/url] |
Q1F | 废止 | 废止时间:2006-6-8 | Stability Data Package for Registration Applicati** in Climatic Zones III and IV
|
气候带III和IV注册申请的稳定性数据包
|
Q2 Analytical Validation (分析方法验证) |
Q2(R1) | Step 5 | 2005-11 | Validation of Analytical Procedures: Text and Methodology |
分析方法验证:文本及方法学
|
Q3 Impurities (杂质) |
Q3A(R2) | Step 5 | 2006-10-25 | Impurities in New Drug Substances |
新原料药中的杂质 |
Q3B(R2) | Step 5 | 2006-6-2 | Impurities in New Drug Products |
新药制剂中的杂质 |
Q3C(R6) | Step 5 | 2016-10-20 | Impurities: Guideline for Residual Solvents |
杂质:残留溶剂指南
|
Q3D | Step 5 | 2014-12-16 | Guideline for Elemental Impurities |
元素杂质指南
|
Q4 Pharmacopoeias (药典) |
Q4 |
| | Pharmacopoeias
|
药典
|
Q4A |
| | Pharmacopoeial Harmonisation
|
药典的同一化
|
Q4B | Step 5 | 2007-11-1 | Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regi** |
ICH各地区使用的药典正文评估和建议 |
Q4B Annex 1 (R1) | Step 5 | 2010-9-27 | Residue on Ignition/Sulphated Ash General Chapter |
关于ICH区域内药典附录的评价及建议-炽灼残渣(硫酸灰分)检查法 |
Q4B Annex 2 (R1) | Step 5 | 2010-9-27 | Test for Extractable Volume of Parenteral Preparati** General Chapter |
关于ICH区域内药典附录的评价及建议-注射剂装量检查法 |
Q4B Annex 3 (R1) | Step 5 | 2010-9-27 | Test for Particulate Con**ination: Sub-Visible Particles General Chapter |
关于ICH区域内药典附录的评价及建议-不溶性微粒检查法 |
Q4B Annex 4A (R1) | Step 5 | 2010-9-27 | [url=]Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter |
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查:微生物计数法 |
Q4B Annex 4B (R1) | Step 5 | 2010-9-27 | Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter |
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查:控制菌检查法 |
Q4B Annex 4C (R1) | Step 5 | 2010-9-27 | Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparati** and Substances for Pharmaceutical Use General Chapter |
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查:原料药及其制剂的判定标准 |
Q4B Annex 5 (R1) | Step 5 | 2010-9- | Disintegration Test General Chapter |
[url=]关于ICH区域内药典附录的评价及建议-崩解时限检查法[/url] |
Q4B Annex 6 | Step 5 | 2013-11-13 | [url=]Uniformity of Dosage Units General Chapter[/url] |
关于ICH区域内药典附录的评价及建议-含量均匀度检查法
|
Q4B Annex 7 (R2) | Step 5 | 2010-11-11 | [url=]Dissolution Test General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-溶出度检查法[/url] |
Q4B Annex 8 (R1) | Step 5 | 2010-9-27 | [url=]Sterility Test General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-无菌检查法[/url] |
Q4B Annex 9 (R1) | Step 5 | 2010-9-27 | [url=]Tablet Friability General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-片剂脆碎度检查法[/url] |
Q4B Annex 10 (R1) | Step 5 | 2010-9-27 | [url=]Polyacrylamide Gel Electrophoresis General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-聚丙烯酰胺凝胶电泳法[/url] |
Q4B Annex 11 | Step 5 | 2010-6-9 | [url=]Capillary Electrophoresis General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-毛细管电泳法[/url] |
Q4B Annex 12 | Step 5 | 2010-6-9 | [url=]Analytical Sieving General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-筛分法[/url] |
Q4B Annex 13 | Step 5 | 2012-6-7 | [url=]Bulk Density and Tapped Density of Powders General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-粉末的堆密度和拍实密度测定法[/url] |
Q4B Annex 14 | Step 5 | 2012-10-18 | [url=]Bacterial Endotoxins Test General Chapter[/url] |
[url=]关于ICH区域内药典附录的评价及建议-细菌内毒素检查法[/url] |
Q5 Quality of Biotechnological Products (生物技术产品的质量) |
Q5A(R1) | Step 5 | 1999-9-23 | [url=]Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin[/url] |
[url=]来源于人或动物细胞系的生物技术产品的病毒安全性评价[/url] |
Q5B | Step 5 | 1995-11-30 | [url=]Quality of Biotechnological Products: Analysis of the Expression C**truct in Cells Used for Production of r-DNA Derived Protein Products[/url] |
[url=]生物技术产品的质量:rDNA衍生蛋白质产品生产细胞的表达构建体分析[/url] |
Q5C | Step 5 | 1995-11-30 | [url=]Quality of Biotechnological Products: Analysis of the Expression C**truct in Cells Used for Production of r-DNA Derived Protein Products[/url] |
[url=]生物技术产品的质量:生物制品/生物技术产品的稳定性试验[/url] |
Q5D | Step 5 | 1997-7-16 | [url=]Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products[/url] |
[url=]用于生物技术产品及生物制品生产的细胞基质的来源和鉴定[/url] |
Q5E | Step 5 | 2004-11-18 | [url=]Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process[/url] |
[url=]生物技术产品/生物制品在工艺变更时的可比性[/url] |
Q6 Specificati** (质量标准) |
Q6A | Step 5 | 1999-10-6 | [url=]Specificati** : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances[/url] |
[url=]质量标准 新原料药和制剂的检测以及可接受标准:化学物质[/url] |
Q6B | Step 5 | 1999-3-10 | [url=]Specificati** : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products[/url] |
[url=]质量标准:生物技术产品以及生物制品的检测方法和可接受标准[/url] |
Q7 Good Manufacturing Practice (生产质量管理规范) |
Q7 | Step 5 | 2000-11-10 | [url=]Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients[/url] |
原料药生产的GMP指南
|
Q7 Q&As | Step 5 | 2015-6-10 | [url=]Questi** and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients[/url] |
[url=]原料药生产的GMP指南的问与答[/url] |
Q8 Pharmaceutical Development (药品研发) |
Q8(R2) | Step 5 | 2009-8 | [url=]Pharmaceutical Development[/url] |
[url=]药品研发[/url] |
Q9 Quality Risk Management (质量风险管理) |
Q9 | Step 5 | 2005-11-9 | [url=]Quality Risk Management[/url] |
质量风险管理
|
Q10 Pharmaceutical Quality System (药物质量体系) |
Q10 | Step 5 | 2008-6-4 | [url=]Pharmaceutical Quality System[/url] |
[url=]药品质量体系[/url] |
Q8/9/10 Q&As(R4) | Step 5 |
| [url=]Q8/Q9/Q10 Questi** and Answers[/url] |
[url=]Q8,Q9,Q10的问与答[/url] |
Q11 Development and Manufacture of Drug Substances (原料药而研发和生产) |
Q11 | Step 5 | 2012-5-1 | [url=]Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)[/url] |
[url=]药物的研发和生产(化学实体和生物技术产品/生物制品实体)[/url] |
Q11 Q&As | Step 3 |
| [url=]Questi** & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances[/url] |
Q11的问与答
|
Q12 Lifecycle Management (生命周期管理) |
Q12 | Step 1 |
| Technical and Regulatory C**iderati** for Pharmaceutical Product Lifecycle Management
|
药品生命周期的技术和监管考虑
|