GB/T 35655-2017 English PDF

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GB/T 35655-2017: Guideline for verification and validation of chemical analysis method and internal quality control -- Chromatography
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 35655-2017	1479	Add to Cart	10 days	Guideline for verification and validation of chemical analysis method and internal quality control -- Chromatography	Valid

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GB/T 39011   GB/T 38356   GB/T 35253   GB/T 35657   GB/T 35656   

Basic data

Standard ID: GB/T 35655-2017 (GB/T35655-2017)
Description (Translated English): Guideline for verification and validation of chemical analysis method and internal quality control -- Chromatography
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A00
Classification of International Standard: 03.120.10
Word Count Estimation: 74,738
Date of Issue: 2017-12-29
Date of Implementation: 2018-07-01
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China

GB/T 35655-2017: Guideline for verification and validation of chemical analysis method and internal quality control -- Chromatography

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Guideline for verification and validation of chemical analysis method and internal quality control-Chromatography ICS 03.120.10 A00 National Standards of People's Republic of China Chemical Analysis Method Verification Confirmation and Internal Quality Control Implementation Guide Chromatography Published on.2017-12-29 2018-07-01 Implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration released Directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General 2 5 Method Verification Confirmation Technology 2 5.1 Analysis System Adaptability 2 5.2 Selectivity 3 5.3 Stability 3 5.4 Durability 4 5.5 Linearity and Calibration 4 5.6 Recovery rate 6 5.7 Limits of Detection and Limits of Quantification 6 5.8 Accuracy 6 5.9 Precision 8 5.10 Measurement uncertainty 9 6 Inspection Process Quality Control 10 7 Analysis System Verification 10 7.1 General 10 7.2 Participate in proficiency testing or measurement audit plan 10 7.3 Inter-laboratory comparison 10 7.4 Using Control Chart Verification and Analysis System 11 Appendix A (Informative Appendix) Calibration Curve Linear Evaluation Example 13 Appendix B (informative annex) Example of evaluation of the significance of recovery 28 Appendix C (Informative) Evaluation Limits and Limits of Quantification Example 31 Appendix D (Informative Appendix) Example of Accuracy Evaluation 41 Appendix E (Informative) Precision Evaluation Example 44 Appendix F (Informative) Evaluation Examples of Measurement Uncertainty 52 Appendix G (Informative) Control Chart Application Example 60 References 70

Foreword

This standard is one of a series of standards for the validation and confirmation of the testing methods of the chemical analysis laboratory and the internal quality control. This series of standards includes the following standard. --- GB/T 32464 Chemical analysis laboratory internal quality control use control chart verification analysis system; --- GB/T 32465 Chemical Analysis Method Verification Confirmation and Internal Quality Control Requirements; --- GB/T 32467 Chemical Analysis Method Verification Validation and Internal Quality Control Terms and Definitions; ---GB/T 33464 Guidelines for the preparation and use of standard operating procedures for chemical analysis; --- GB/T 35656 Methods for the validation of chemical analysis method validation and internal quality control implementation guidelines to report qualitative results; ---GB/T 35657 Chemical Analysis Method Validation Validation and Internal Quality Control Implementation Guide Based on Sample Digested Metal Fractions analysis. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Standardization Technical Committee for Quality Inspection Key Product Inspection Methods (SAC/TC374). This standard was drafted by. Sichuan Province Product Quality Supervision, Inspection and Testing Institute, Zhonghua Warner (Beijing) Quality Technology Center Co., Ltd., China Inspection Union (Beijing) Quality Inspection Technology Research Institute Co., Ltd., Sichuan Food and Drug Supervision and Inspection Institute, Dongguan City, Guangdong Province Quality Supervision and Inspection Center, Beijing Yingtai Jiahe Analysis Technology Co., Ltd., Sichuan Institute of Technology, Jiangsu Lianhua Science and Technology Co., Ltd., Hubei Saning Chemical Industry Co., Ltd., Chengdu Hongyi Industrial Group Co., Ltd. The main drafters of this standard. Zheng Weidong, Fan Zhigang, Huang Hao, Yu Xiaoqin, Zhang Liping, Fu Dayou, Tan Wenyuan, Lin Hong, Wang Junfang, He Xuefen, Lai Yidong, Li Hongxia, Wen Huazhen, Cheng Xiaohong, Li Wanqing. Chemical Analysis Method Verification Confirmation and Internal Quality Control Implementation Guide Chromatography

1 Scope

This standard gives guidelines for the validation of method validation based on chromatographic analysis and the establishment of an internal laboratory quality control system, including Then, method verification verification technology, inspection process quality control and analysis system verification. This standard is applicable to the verification and confirmation of the method based on chromatographic analysis and the establishment of an internal laboratory quality control system.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 6379.1 Accuracy (correctness and precision) of measurement methods and results Part 1. General rules and definitions GB/T 6379.4-2006 Accuracy (trueness and precision) of measurement methods and results Part 4. Determination of standard measures The correct basic method of law GB/T 6379.6-2009 Accuracy (trueness and precision) of measurement methods and results Part 6. Actual values of actuality application GB/T 10092-2009 Statistical analysis of data and interpretation of multiple comparisons of test results GB/T 14666 Analytical Chemistry Terms GB/T 15000.3 Working guide for standard samples (2) General principles and statistical methods for setting standard samples GB 17378.2-2007 Marine Monitoring Code Part 2. Data Processing and Analysis Quality Control GB/T 19000 Quality Management System Foundation and Terminology GB/T 22554-2010 Linear calibration based on standard samples GB/T 27407 Laboratory Quality Control Utilization Statistical Quality Assurance and Control Chart Technical Evaluation Analysis and Measurement System Performance GB/T 27411-2012 Uncertainty Evaluation Methods and Expressions Used in Testing Laboratories GB/T 32464-2015 verification of chemical analysis method validation and internal quality control use control chart verification and analysis system GB/T 32465-2015 verification of chemical analysis methods and internal quality control requirements GB/T 32467 Chemical Analysis Method Verification Verification and Internal Quality Control Terms and Definitions GB/T 33464 Guidelines for the preparation and use of standard operating procedures for chemical analysis JJF1059.1 Evaluation and Expression of Measurement Uncertainty ISO 11843-1 Detection Capability. Terms and Definitions (Capabilityofdetection-Part 1.Termsanddefinitions) Retrieval Rate Information Application Conformance Guide for Analytical Measurements [IUPACHarmonisedGuidelinesfortheUseofRecovery InformationinAnalyticalMeasurement(IUPACTechnical)]

3 Terms and Definitions

The terms and definitions defined in GB/T 6379.1, GB/T 14666, GB/T 19000, GB/T 32467 and ISO 11843-1 apply In this document. ......

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