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GB/T 32467-2015Verification and validation of methods and internal quality contorl on chemical (English PDF)

化学分析方法验证确认和内部质量控制 术语及定义

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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 32467-2015 is the English-translated version of 化学分析方法验证确认和内部质量控制 术语及定义.

GB/T 32467-2015 is the Chinese standard "Verification and validation of methods and internal quality contorl on chemical".

Its scope clause reads: This standard specifies the chemical analysis and testing process, method detection capability, recovery rate, linearity and calibration, quality control samples, detection methods, management, Chemical analysis methods Verification and terminology and definitions of internal quality control.

This standard applies to laboratory chemical analysis methods to verify and internal quality control. Its clauses include test procedure terms and definitions.

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Document preview — GB/T 32467-2015

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

Contents

  • 1 Scope
  • 2 Test procedure terms and definitions
  • 2.1 Inspection
  • 2.2 Test
  • 2.3 Target analyte
  • 2.4 Analysis sequence analyticalseries
  • 2.5 Analysis program analyticalprocedures
  • 2.6 Standard operating procedures standardoperationprocedure; SOP
  • 2.7 Independent repetitive detection of

1 Scope

This standard specifies the chemical analysis and testing process, method detection capability, recovery rate, linearity and calibration, quality control samples, detection methods, management,

Chemical analysis methods Verification and terminology and definitions of internal quality control.

This standard applies to laboratory chemical analysis methods to verify and internal quality control.

2 Test procedure terms and definitions

2.1 Inspection

Through the test, test or estimate, combined with the observation and judgment of the compliance evaluation.

Note. rewrite GB/T 19000-2008, defined 3.8.2.

2.2 Test

The technical operation of a given product, in accordance with the prescribed procedure, determines one or more characteristics, processing or provision of services.

Note. rewrite JJF1001-2011, defined 9.46.

2.3 Target analyte

Analyte

Target component objectivecomponents

Present in the test sample, the detected component specified by the method.

Note. The target analyte can be a single component or a mixed component.

2.4 Analysis sequence analyticalseries

Analysis of batchrun

A set of regular and quality control samples.

Note. see GB/T 3358.2-2009, definition 3.5.11.

2.5 Analysis program analyticalprocedures

The test program determinationprocedures

A detailed description of the steps/procedures for detection (analysis, testing).

2.6 Standard operating procedures standardoperationprocedure; SOP

The standard operational procedures and requirements for a particular activity are described in a uniform format to guide and standardize the specific activity.

Procedures to ensure consistency of the document.

2.7 Independent repetitive detection of

In the chemical analysis test, the current test is not affected by the same or similar sample detection in the past, including the independent preparation of the test sample, random […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

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