Quality Guidelines
质量
编号阶段内容
Q1A(R2)Step 5Stability Testing of New Drug Substances and Products
新原料药和制剂的稳定性试验
Q1BStep 5Stability 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
Q1CStep 5Stability Testing for New Dosage Forms
稳定性试验:新剂型的要求
Q1DStep 5Bracketing 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
Q1EStep 5Evaluation of Stability Data
稳定性数据的评价
Q1F废止Stability Data Package for Registration Applications in Climatic Zones III and IV
气候带III和IV注册申请的稳定性数据包
Q2(R1)Step 5Validation of Analytical Procedures: Text and Methodology
分析方法验证:文本及方法学
Q3A(R2)Step 5Impurities in New Drug Substances
新原料药中的杂质
Q3B(R2)Step 5Impurities in New Drug Products
新药制剂中的杂质
Q3C(R6)Step 5Impurities: Guideline for Residual Solvents
杂质:残留溶剂指南
Q3DStep 5Guideline for Elemental Impurities
元素杂质指南
Q4Pharmacopoeias
药典
Q4APharmacopoeial Harmonisation
药典的同一化
Q4BStep 5Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH各地区使用的药典正文评估和建议
Q4B Annex 1 (R1)Step 5Residue 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 5Test for Extractable Volume of Parenteral Preparations 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 5Test for Particulate Contamination: 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 5Microbiological 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 5Microbiological 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 5Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations 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 5Disintegration Test General Chapter
关于ICH区域内药典附录的评价及建议-崩解时限检查法
Q4B Annex 6Step 5Uniformity of Dosage Units General Chapter
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 5Dissolution Test General Chapter
关于ICH区域内药典附录的评价及建议-溶出度检查法
Q4B Annex 8 (R1)Step 5Sterility Test General Chapter
关于ICH区域内药典附录的评价及建议-无菌检查法
Q4B Annex 9 (R1)Step 5Tablet Friability General Chapter
关于ICH区域内药典附录的评价及建议-片剂脆碎度检查法
Q4B Annex 10 (R1)Step 5Polyacrylamide Gel Electrophoresis General Chapter
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
Q4B Annex 11Step 5Capillary Electrophoresis General Chapter
关于ICH区域内药典附录的评价及建议-毛细管电泳法
Q4B Annex 12Step 5Analytical Sieving General Chapter
关于ICH区域内药典附录的评价及建议-筛分法
Q4B Annex 13Step 5Bulk Density and Tapped Density of Powders General Chapter
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
Q4B Annex 14Step 5Bacterial Endotoxins Test General Chapter
关于ICH区域内药典附录的评价及建议-细菌内毒素检查法
Q5A(R1)Step 5Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
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
Q5BStep 5Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
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
Q5CStep 5Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
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
Q5DStep 5Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
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
Q5EStep 5Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
生物技术产品/生物制品在工艺变更时的可比性
Q6AStep 5Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
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
Q6BStep 5Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
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
Q7Step 5Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
原料药生产的GMP指南
Q7 Q&AsStep 5Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
原料药生产的GMP指南的问与答
Q8(R2)Step 5Pharmaceutical Development
药品研发
Q9Step 5Quality Risk Management
质量风险管理
Q10Step 5Pharmaceutical Quality System
药品质量体系
Q8/9/10 Q&As(R4)Step 5Q8/Q9/Q10 Questions and Answers
Q8,Q9,Q10的问与答
Q11Step 5Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
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)
Q11 Q&AsStep 3Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Q11的问与答
Q12Step 1Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
药品生命周期的技术和监管考虑
 
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