GB/T 32467-2015 in English

VALID

Verification and validation of methods and internal quality contorl on chemical analysis — Terms and definitions

Issued on:2015-12-31
Implemented on:2016-07-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $370.00
$359.00

Standard No:	GB/T 32467-2015
Document status:	VALID
Title in English:	Verification and validation of methods and internal quality contorl on chemical analysis — Terms and definitions
Title in Chinese:	化学分析方法验证确认和内部质量控制术语及定义
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2015-12-31
Implemented on:	2016-07-01
Professional Classification:	GB-National Standard
Related Keywords:	method validation quality control chemical analysis terms internal quality contorl definitions introduction analysis analysis object
Related Topics:	Measuring range in method validation Method Verification Method Validation method validation and Method Validation for Chemical Analysis Chemical Analysis Method Validation Confirmation and Implementation Guidelines for Internal Quality Control Metal Component Analysis Based on Sample Digestion Validation and Validation of Analytical Methods Analytical Method Validation Confirmation Confirm ingredient chemistry About Method Validation and Method Validation Method Validation Confirmation Terms and Definitions for Validation, Validation and Internal Quality Control of Chemical Analysis Methods internal verification group Chemical Analysis Method Validation Confirmation of measurement method Method Validation Confirmation Chromatographic Method Validation Confirmation Guidelines for Validation, Validation, and Internal Quality Control Implementation of Chemical Analysis Methods Chromatographic Analysis method validation Domestic method confirmation Analytical Method Validation and Validation Confirmation, Verification Test Method validation part Bromine and Misin Method Validation Total methodology validation Standard Method Validation Techniques Quality Analysis Verification Method Analytical method validation and validation Validation of quality analysis methods Analytical Method Validation and Validation Flow method validation Analytical method validation and analytical method validation confirm and confirm confirm and confirm Confirm validation definition Definitions of Verification and Validation Methodology Validation Substances Validation of statutory analytical methods Definitions of Method Validation and Method Validation Detection method and method confirmation Quality and Method Validation chemical law definition confirmed definition GB/T 32467 How to confirm the measurement method Analytical Chemistry Quality Control GBT32467 GB/T 32467-2015 The difference between analytical method validation and analytical method validation IND intermediate analysis method confirms regulatory requirements GB/t32467 What to do to confirm the analysis method What is the difference between method validation and method validation? 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What is the difference between method validation and method validation? Analytical method development Instrument validation Methodological validation content for biological sample analysis Similarities between method verification and validation gb32467 European Pharmacopoeia Analytical Method Validation Contents API analysis method verification content Similarities and Differences between Method Verification and Method Validation Laboratory method validation and method validation Contents and requirements for validation of analytical methods Partial and full validation of analytical methods The difference between method validation and verification Pharmacopoeia Analytical Methodology Validation The difference between validation and confirmation of analytical methods Methodological verification of stability of related substances The difference between validation and verification of analytical methods Validation of analytical methodology

《GB/T 32467-2015化学分析方法验证确认和内部质量控制术语及定义》由TC374（全国质量监管重点产品检验方法标准化技术委员会）归口，主管部门为国家标准化管理委员会。
本标准规定了化学分析检测过程、方法检测能力、回收率、线性和校准、质控样品、检测方法、管理、化学分析方法验证确认和内部质量控制的术语及定义
本标准适用于实验室化学分析方法验证确认和内部质量控制。

Introduction

Analysis of the core terminology system of the standard

I. Key terms in the detection process

2.3 Target analyte: The specific component to be detected, which can be a single or mixed component. In food testing, such as the analysis object of the gas chromatograph for pesticide residue detection.

2.10 Blank: It is divided into reagent blank, sample blank and standard solution blank, which are used to eliminate systematic errors. The case shows that the reagent blank can reduce the baseline noise of the liquid chromatography.

II. Method Capability Evaluation Indicators

Terms	Definition Points	Application Scenarios
9.19 Limit of Detection (LOD)	The minimum concentration for statistically distinguishing blanks	Heavy Metal Detection Method Development
9.21 Limit of Quantitation (LOQ)	The minimum concentration that meets the accuracy requirements	Determination of drug content
9.40 Precision	Consistency between results	Inter-laboratory comparison

III. Evolution of Standard Technology

This standard integrates 6 international standards including ISO 11843, and amends terms such as "accuracy" to align with international standards. In particular, the state variable system is introduced in chapters 3.1-3.11 to improve the theoretical framework for testing capability evaluation.

IV. Implementation Suggestions

Laboratories should establish a terminology comparison table (refer to Appendix A)
Performance indicators 9.12-9.17 need to be clarified during method validation
Quality control needs to distinguish between target control limits 9.33 and statistical control limits 9.34

More samples: DL/T 5154-2012 JJG 21-2008 GB 50021-2001(2009)

Sample only — not a preview of GB/T 32467-2015

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