Process / pipelineQuality Assurance and Validation
分析方法验证
分析方法验证是一个系统化的过程，旨在建立有据可查的证据，证明分析方法适用于其预期的用途，用于测量物质的同一性、纯度、强度和/或含量。方法验证受监管机构（如FDA、ICH）和行业标准（如USP、EP）的指导，确保分析方法在制药、食品、化工和环境行业的质量控制中是可靠、准确且适用的。方法验证对于监管申报是强制性的，也是良好生产规范（GMP）的基石。
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Method map
The neighbourhood of related methods — select a node to explore.
来源
- Food and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry. link ↗
- International Council for Harmonisation. (2005). ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology. ICH Harmonised Tripartite Guideline. link ↗
- United States Pharmacopeia. (2021). Chapter <1225> Validation of Compendial Procedures. USP 44-NF 39. link ↗
如何引用本页
ScholarGate. (2026, June 3). Analytical Method Validation. ScholarGate. https://scholargate.app/zh/analytical-chemistry/method-validation-analytical
Which method?
Set this method beside its closest kin and read them side by side — the library lays the books on the table; the choice is yours.
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