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GB/T 32465-2015Requirement for verification & validation of detection methods and internal quality (English PDF)

化学分析方法验证确认和内部质量控制要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 31, 2015

Implementation date

July 1, 2016

Scope

GB/T 32465-2015 is the English-translated version of 化学分析方法验证确认和内部质量控制要求.

GB/T 32465-2015 is the Chinese standard "Requirement for verification & validation of detection methods and internal quality". Its scope clause reads: 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.

Its clauses include normative reference documents; terms and definitions; method selection.

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Document preview — GB/T 32465-2015

National Standard of the People's Republic of China

ICS: 03.120.10
Classification: A 00

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Preface
Introduction
1 Scope
2 normative reference document
3 Terms and definitions
4 method selection
5 General
6 nonstandard method traceability requirements
7 on the method performance indicators to verify and confirm the requirements
7.1 Analysis System Adaptability
7.2 blank detection
7.3 correctness
7.4 precision
7.5 Detection limit and limit of quantification
7.6 Linearity and Calibration
7.7 Selectivity
7.8 Stability
7.9 Durability
7.10 Recovery rate
7.11 detection capability
7.12 Measurement Uncertainty Assessment
8 SOP
9 IQC requirements
9.2 Requirements for analytical batches
9.3 IQC composition
9.4 Quality control requirements for testing process
9.5 record
9.6 Analysis System Verification
Appendix A (informative) Guidelines for the field of chromatographic analysis
Appendix B (informative) Relationship between IQC and Quality Assurance Measures
References

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

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