ICH指导原则中validation实施的目的为The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose.(目的是证明该分析方法与其预期目的相适应。)并列举出4种最常见的操作方法:鉴别试验、杂质的定量试验、杂质控制的限度试验、原料药或制剂中活性成分以及制剂...
4.10 Linearity The linearity of an analytical procedure is its ability (within a given range) to obtain test results from an analytical response which are directly proportional to the concentration (amount) of analyte in the sample. 4.11 Range The range of an analytical procedure is the interval...
validation_of_analytical_proceduresEDQM分析方法学验证 系统标签: validationanalyticaledqmproceduresomcl分析方法 OMCLNetworkoftheCouncilofEuropeGENERALDOCUMENTPA/PH/OMCL(13)822RVALIDATIONOFANALYTICALPROCEDURESFulldocumenttitleandreferenceValidationofAnalyticalProceduresPA/PH/OMCL(13)822RDocumenttypeGuidelineLegislativebasis...
ANALYTICAL PROCEDURE The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the ...
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities, and assay procedures is included. Other analytical procedures may be considered in future...
VALIDATION OF ANALYTICAL PROCEDURES Full document title and reference Validation of Analytical Procedures PA/PH/OMCL (13) 82 2R Document type Guideline Legislative basis The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System ...
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good ana...
搭配process validation和validation of analytical procedure同样可以说明validation在药品质量管理领域与工艺和方法搭配得最多,目的是标准的确认,这与“验证”的定义完全一致。 其次,《药学名词》(第2版)中虽然没有给出validation的翻译,但是将revalidation译为“再验证”,据此可推断validation翻译为“验证”是被认可的翻译...
Validation of AnalyticalMethods: Definitions and Terminology, 27 October 1994" and "ICH Q2B: Validation of Analytical Procedure: Methodology, 6 November 1996... IFPMA - 《Federal Register》 被引量: 0发表: 1995年 Validation of computerized analytical systems, Part I: Overview, regulations, and ter...
Text on Validation of Analytical Procedure( Parent Guideline) --1994/10 ICH Q2B: Validation of Analytical Procedures: Methodology (Developed to complement the Parent guideline)—1996/11 • 2005药典比ICH要求多“耐用性”,但ICH强调 在方法开发阶段要考虑这一点 • USP<1225> Validation of Compendia...