ICH指导原则 - 蒲标网

Quality of Biotechnological Products
生物技术产品的质量

编号	阶段	内容
Q5A(R1)	Step 5	Viral 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
Q5B	Step 5	Quality 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
Q5C	Step 5	Quality 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
Q5D	Step 5	Derivation 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
Q5E	Step 5	Comparability 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

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