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GB/T 32465-2015: Requirements for verification and validation of detection methods and internal quality control on chemical analysis
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Requirements for verification and validation of detection methods and internal quality control on chemical analysis
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GB/T 32465-2015
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Basic data | Standard ID | GB/T 32465-2015 (GB/T32465-2015) | | Description (Translated English) | Requirements for verification and validation of detection methods and internal quality control on chemical analysis | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A00 | | Classification of International Standard | 03.120.10 | | Word Count Estimation | 23,277 | | Date of Issue | 2015-12-31 | | Date of Implementation | 2016-07-01 | | Quoted Standard | GB/T 6379.1-2004; GB/T 19000-2008; GB/T 22554; GB/T 27025-2008; GB/T 27407; GB/T 32464-2015; GB/T 32467-2015; ISO 11843-1-2008; ISO 11843-2; ISO 11843-3; ISO 11843-4 | | Regulation (derived from) | State Standard Announcement 2015 No.43 | | 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 | | Summary | This standard specifies requirements for validation of chemical analysis methods and for internal quality control in laboratories. This standard applies to the verification of chemical analysis methods and laboratory internal quality control, but this standard only involves quantitative analysis methods, and does not include the sampling part. | GB/T 32465-2015: Requirements for verification and validation of detection methods and internal quality control on chemical analysis
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Requirements for verification and validation of detection methods and internal quality control on chemical analysis
ICS 03.120.10
A00
National Standards of People's Republic of China
Chemical analysis method validation confirmation and
Internal quality control requirements
2015-12-31 released
2016-07-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Management Committee released
Directory
Preface III
Introduction IV
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 method selection 1
5 General 2
6 nonstandard method traceability requirements 2
7 on the method performance indicators to verify and confirm the requirements 2
7.1 Analysis System Adaptability 2
7.2 blank detection 3
7.3 correctness 3
7.4 precision 3
7.5 Detection limit and limit of quantification 5
7.6 Linearity and Calibration 5
7.7 Selectivity 6
7.8 Stability 6
7.9 Durability 7
7.10 Recovery rate 7
7.11 detection capability 7
7.12 Measurement Uncertainty Assessment 7
8 SOP 7
9 IQC requirements 8
Basic requirements for quality control samples
9.2 Requirements for analytical batches 8
9.3 IQC composition 8
9.4 Quality control requirements for testing process 8
9.5 record 9
9.6 Analysis System Verification 9
Appendix A (informative) Guidelines for the field of chromatographic analysis
Appendix B (informative) Relationship between IQC and Quality Assurance Measures 15
References 16
Foreword
This standard is drafted in accordance with the requirements of GB/T 1.1-2009.
This standard is proposed and centralized by the National Standardization Technical Committee for Quality Supervision and Testing of Key Products (SAC/TC374).
The standard drafting unit. Sichuan Province Product Quality Supervision, Inspection and Testing Institute, in the inspection Warner (Beijing) Quality Technology Center Co., Ltd., Luzhou
(Beijing) Quality Inspection Technology Research Institute Co., Ltd., Sichuan Province Food and Drug Inspection and Testing Institute, Guangyuan City
Quality Supervision and Inspection Institute, Chengdu Hong billion Industrial Group Limited.
The main drafters of this standard. Zheng Weidong, Hu Dan, Yin Jianjun, Zhang Xicui, Fan Zhigang, Li Wei, Wang Ming, Zhang Shanyi.
Introduction
This standard is a chemical analysis laboratory test method validation and internal quality control (InternalQualityControl, IQC) series
One of the standards. It is recommended that the Chemical Analysis Laboratory use this standard and other criteria in the standard.
Method validation or validation is the basis for the establishment of a reliable analytical system in the laboratory and is a necessary procedure in chemical analysis. In the implementation of the analysis
During the testing process, the purpose of laboratory quality control is to ensure that the established analytical system is stable and reliable; the second is to implement the analysis system to verify
The stability of the analysis system, the realization of these two purposes are inseparable from the method to verify or confirm the results as a basis.
This standard puts forward the laboratory chemical analysis method to verify, confirm and establish a reliable analysis system, and the establishment of internal quality control body
System requirements.
Standard by the method of choice, general, non-standard method of traceability requirements, the method of performance indicators to verify and confirm the requirements of the standard operating procedures
(StandardOperationProcedures, SOP), internal quality control requirements, and two informative appendices.
Chemical analysis method validation confirmation and
Internal quality control requirements
1 Scope
This standard specifies the requirements for validation of chemical analysis methods and internal quality control within the laboratory.
This standard applies to the validation of chemical analysis methods and laboratory internal quality control, but this standard only involves quantitative analysis methods, and not
Including the sampling section.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 6379.1-2004 Accuracy (accuracy and precision) of measurement methods and results - Part 1. General and definitions
Quality management systems - Fundamentals and terminology GB/T 19000-2008
GB/T 22554 Linear calibration based on standard samples
GB/T 27025-2008 General requirements for testing and calibration laboratory capabilities
GB/T 27407 Laboratory Quality Control Using Statistical Quality Assurance and Control Charts to Evaluate the Performance of Measurement Systems
GB/T 32464-2015 Chemical Analysis Laboratory Internal Quality Control Using Control Chart Verification Analysis System
GB/T 32467-2015 Chemical analysis methods Verification and internal quality control Terms and definitions
ISO 11843-1..2008 Testing Capability - Part 1. Terms and definitions (Capabilityofdetection-Part 1. Terms
anddefinitions)
ISO 11843-2 Testing Capability Part 2. Linear Correction Method (Capabilityofdetection-Part 2. Methodology
inthelinearcalibrationcase
ISO 11843-3 Testing capability - Part 3. Determination of the critical value of the reaction variable when no calibration data is used (Capabilityof
detection-Part 3. Methodologyfordeterminationofthecriticalvaluefortheresponsevariablewhen
nocalibrationdataareused
ISO 11843-4 Detection Capability Part 4. Method of comparing the minimum detectable value to a given value (Capabilityof
detection-Part 4. Methodologyforcomparingtheminimumdetectablevaluewithagivenvalue)
3 terms and definitions
GB/T 6379.1-2004, GB/T 19000-2008, GB/T 32467-2015, ISO 11843-1..2008 Definitions and
The definitions apply to this document.
4 method selection
4.1 The laboratory selection method should meet the requirements of 5.4.2 in GB/T 27025-2008.
4.2 In addition to specific contractual or customer requirements, the laboratory should give priority to the use of international, regional, national standards published in the method.
4.3 The method used in the laboratory is not the method listed in this standard 4.2, but the relevant national functional departments, well-known technical organizations or related subjects
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