|
1
|
Q1 Stability/稳定性
|
|
|
Q1A(R2):
Stability Testing of New Drug Substances and Products
|
Q1A(R2)：新原料药和制剂的稳定性试验
|
阶段5
|
2003.2.6
|
有
|
|
Q1B:
Stability Testing: Photostability Testing of New Drug Substances and
Products
|
Q1B: 稳定性试验：新原料药和制剂的光稳定性试验
|
阶段5
|
1996.11.6
|
有
|
|
Q1C:
Stability Testing for New Dosage Forms
|
Q1C：新剂型的稳定性试验
|
阶段5
|
1996.11.6
|
有
|
|
Q1D:
Bracketing and Matrixing Designs for Stability Testing of New Drug
Substances and Products
|
Q1D：新原料药和制剂稳定性试验的括号法和矩阵法设计
|
阶段5
|
2002.2.7
|
有
|
|
Q1E:
Evaluation for Stability Data
|
Q1E：稳定性数据的评价
|
阶段5
|
2003.2.6
|
有
|
|
2
|
Q2 Analytical
Validation/分析方法验证
|
|
|
Q2(R1):
Validation of Analytical Procedures Text and Methodology
|
Q2（R1）：分析方法论证：正文和方法学
|
阶段5
|
2005.11
|
有
|
|
3
|
Q3A - Q3D
Impurities/杂质
|
|
|
Q3A(R2):
Impurities in New Drug Substances
|
Q3A（R2）：新原料药中的杂质
|
阶段5
|
2006.10.25
|
有
|
|
Q3B(R2):
Impurities in New Drug Products
|
Q3B（R2）：新药制剂中的杂质
|
阶段5
|
2006.6.2
|
有
|
|
Q3C(R8)
Impurities：Guideline for Residual Solvents
|
Q3C（R8）：杂质：残留溶剂的指导原则
|
阶段5
|
2021.4.22
|
有
|
|
Q3D(R1):
Guideline for Elemental Impurities
|
Q3D（R1）：元素杂质指导原则
|
阶段5
|
2019.3.22
|
有
|
|
4
|
Q4 - Q4B
Pharmacopoeias/药典
|
|
|
Q4B:
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH
Regions
|
Q4B：ICH区域所用药典文本的评价和建议
|
阶段5
|
2007.11.1
|
有
|
|
Q4B
Frequently Asked Questions
|
Q4B：常见问题与解答
|
|
2012.4.26
|
|
|
Q4B
Annex 1 (R1): Residue on Ignition/Sulphated Ash General Chapter
|
Q4B附录1(R1): 关于灼烧残渣/灰分 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 2 (R1): Test for Extractable Volume of Parenteral Preparations
General Chapter
|
Q4B附录2(R1): 关于注射剂可提取容量测试 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 3 (R1): Test for Particulate Contamination: Sub-Visible Particles
General Chapter
|
Q4B附录3(R1): 关于颗粒污染物测试:不溶性微粒 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 4A (R1): Microbiological Examination of Non-Sterile Products:
Microbial Enumeration Tests General Chapter
|
Q4B附录4A(R1):非无菌药品的微生物检查：微生物计数试验 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 4B (R1): Microbiological Examination of Non-Sterile Products Tests
for Specified Micro-Organisms General Chapter
|
Q4B附录4B(R1): 非无菌产品的微生物检查—特定微生物 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 4C (R1): Microbiological Examination of Non-Sterile Products:
Acceptance Criteria for Pharmaceutical Preparations and Substances for
Pharmaceutical Use General Chapter
|
Q4B附录4C(R1): 非无菌产品的微生物检查：药物制备以及药物使用物质的接受标准 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 5 (R1): Disintegration Test General Chapter
|
Q4B附录5（R1）：崩解试验 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 6 Uniformity of Dosage Units General Chapter
|
Q4B附录6: 统一剂量单位 常规篇
|
阶段5
|
2013.11.13
|
|
|
Q4B
Annex 7 (R2): Dissolution Test General Chapter
|
Q4B附录7(R2): 溶出试验 常规篇
|
阶段5
|
2010.11.11
|
有
|
|
Q4B
Annex 8 (R1): Sterility Test General Chapter
|
Q4B附录8(R1): 无菌试验 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 9 (R1): Tablet Friability General Chapter
|
Q4B附录9(R1): 片剂易碎性 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 10 (R1): Polyacrylamide Gel Electrophoresis General Chapter
|
Q4B附录10(R1): 聚丙烯酰胺凝胶电泳 常规篇
|
阶段5
|
2010.9.27
|
有
|
|
Q4B
Annex 11: Capillary Electrophoresis General Chapter
|
Q4B附录11：毛细管电泳 常规篇
|
阶段5
|
2010.6.9
|
有
|
|
Q4B
Annex 12: Analytical Sieving General Chapter
|
Q4B附录12：分析筛选 常规篇
|
阶段5
|
2010.6.9
|
有
|
|
Q4B
Annex 13: Bulk Density and Tapped Density of Powders General Chapter
|
Q4B附录13：粉末的堆密度和振实密度
|
阶段5
|
2012.6.7
|
有
|
|
Q4B
Annex 14: Bacterial Endotoxins Test General Chapter
|
Q4B附录14：细菌内毒素试验 常规篇
|
阶段5
|
2012.10.18
|
有
|
|
5
|
Q5A - Q5E
Quality of Biotechnological Products/生物技术产品质量
|
|
|
Q5A(R1):
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines
of Human or Animal Origin
|
Q5A（R1）：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
|
阶段5
|
1999.9.23
|
有
|
|
Q5B:
Analysis of the Expression Construct in Cells Used for Production of r-DNA
Derived Protein Products
|
Q5B：源自重组DNA技术的蛋白质产品的表达载体分析
|
阶段5
|
1995.11.30
|
有
|
|
Q5C:
Stability Testing of Biotechnological/Biological Products
|
Q5C：生物技术生物制品质量：生物技术/生物制品稳定性试验
|
阶段5
|
1995.11.30
|
有
|
|
Q5D:
Derivation and Characterisation of Cell Substrates Used for Production of
BiotechnologicalBiological Products
|
Q5D: 用于生产生物技术/生物产品的细胞底物的起源和特征描述
|
阶段5
|
1997.7.16
|
有
|
|
Q5E:
Comparability of BiotechnologicalBiological Products Subject to Changes in
their Manufacturing Process
|
Q5E：生物技术产品/生物制品在生产工艺变更前后的可比性
|
阶段5
|
2004.11.18
|
有
|
|
6
|
Q6A- Q6B
Specifications/规格
|
|
|
Q6A:
Specifications: Test Procedures and Acceptance Criteria for New Drug
Substances and New Drug Products: Chemical Substances
|
Q6A：质量标准：新原料药和新药制剂的检测方法和可接受标准：化学药物
|
阶段5
|
1999.10.6
|
有
|
|
Q6B:
Specifications: Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products
|
Q6B: 质量规格：生物技术/生物产品的检验程序和可接收标准
|
阶段5
|
1999.3.10
|
有
|
|
7
|
Q7 Good
Manufacturing Practice/GMP
|
|
|
Q7:
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
|
Q7: 原料药GMP指南
|
阶段5
|
2000.11.10
|
有
|
|
Q7 Questions and
Answers
|
Q7 问答部分
|
阶段5
|
2015.6.10
|
|
|
8
|
Q8
Pharmaceutical Development/药物研发
|
|
|
Q8(R2):
Pharmaceutical Development
|
Q8(R2):药品研发
|
阶段5
|
2009.8
|
有
|
|
Q8, Q9
and Q10 Questions & Answers (R4)
|
关于Q8、Q9和Q10的问与答（R4）
|
阶段5
|
2010.11.11
|
有
|
|
9
|
Q9 Quality
Risk Management/质量风险管理
|
|
|
Q9:
Quality Risk Management
|
Q9: 质量风险管理
|
阶段5
|
2005.11.09
|
|
|
10
|
Q10
Pharmaceutical Quality System/药物质量体系
|
|
|
Q10:
Pharmaceutical Quality System
|
Q10：药品质量体系
|
阶段5
|
2008.6.4
|
有
|
|
11
|
Q11
Development and Manufacture of Drug Substances/化学药品的研发与生产
|
|
|
Q11:
Development and Manufacture of Drug Substances (Chemical Entities and
Biotechnological/Biological Entities)
|
Q11：原料药开发和生产（化学实体和生物技术/生物实体药物）
|
阶段5
|
2012.5.1
|
有
|
|
Q11：Questions
and Answers
|
Q11问答：原料药开发和生产（化学实体和生物技术/生物实体药物）问答
|
阶段5
|
2017.8.23
|
有
|
|
12
|
Q12
Techinical And Regulatory Considerations For Pharmaceutical Product
Lifecycle Management药品生命周期管理的技术和监管考虑
|
|
|
Q12：Techinical
And Regulatory Considerations For Pharmaceutical Product Lifecycle
Management
|
Q12：药品生命周期管理的技术和监管考虑
|
阶段5
|
2019.11.20
|
有
|
|
Q12 Annexes
|
Q12附件
|
阶段5
|
2019.11.20
|
有
|
