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Guideline for validation of genetically-modified organism test methods
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SN/T 4561-2016
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Basic data Standard ID | SN/T 4561-2016 (SN/T4561-2016) | Description (Translated English) | Guideline for validation of genetically-modified organism test methods | Sector / Industry | Commodity Inspection Standard (Recommended) | Classification of Chinese Standard | B04 | Word Count Estimation | 10,111 | Date of Issue | 2016-08-23 | Date of Implementation | 2017-03-01 | Regulation (derived from) | State-Quality-Inspection-Certification (2016)438 | Issuing agency(ies) | General Administration of Customs |
SN/T 4561-2016: Guideline for validation of genetically-modified organism test methods---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 validation of genetically-modified organism test methods
China's entry-exit inspection and quarantine industry standards
Genetic Testing Non-standard Method Confirmation Evaluation Guide
Published on.2016-08-23
2017-03-01 Implementation
China
The State Administration of Quality Supervision, Inspection and Quarantine issued
Foreword
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 Certification and Accreditation Regulatory Commission.
This standard was drafted by the People's Republic of China Beijing Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this standard. Rao Hong, Zhang Xiquan, Guo Yilei, Fu Yibo, Li Hong, Liang Xinmiao, Ma Dan, Xu Hao, Han Hong, Lin Yuanhui.
Introduction
In this standard, the technical content and the guidance document prepared by the Joint Research Center of the European Commission “DefinitionofMinimum”
The contents of boratories are exactly the same. The guideline document specifies the criteria for determining the performance indicators involved in the transgenic detection method.
This document is the basis for the EU's assessment of the effectiveness of non-standard detection methods for genetically modified organisms. All genetically modified non-standard within the EU
The confirmation of the test method was evaluated using this document. This standard adopts the technical content of this guide. In the field of genetically modified detection,
There is no guideline industry or national standard norm in the country to unify the scale of confirmation of genetically modified genetic testing methods to ensure that different laboratories are
The method validation work is conducted under the guidance of the technical specifications of the first, so the preparation of this standard.
Genetic Testing Non-standard Method Confirmation Evaluation Guide
1 Scope
This standard specifies terms and definitions, technical schemes, statistical analysis of data, and performance indicators of methods for the validation of genetically modified organism test methods.
Ratings, results reports, etc.
This standard is applicable to the validation of the validation activities involving qualitative and quantitative testing methods for genetically modified organisms in various methods to be formulated or revised.
evaluation of.
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 6379.2 Accuracy (trueness and precision) of measurement methods and results Part 2. Determination of standard measurement methods
The basic method of sex and reproducibility (ISO 5725-2.1994 IDT)
General requirements for GB/T 27025 testing and calibration laboratory capabilities (ISO /IEC 17025.2005 IDT)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Method to be confirmed alternative method
An analytical method to be developed or revised for testing a given target genetically modified organism.
3.2
Benchmark method reference method
Recognized and widely accepted method by international, national or industry or organization. Give priority to the International Organization for Standardization (ISO ) and Chinese national standards
The method recommended by the quasi (GB) and the International Association of Analysts (AOAC) and other internationally recognized methods can also be used as the benchmark method.
3.3
Method validation validationofmethod
Using the statistical methods specified in the approved validation protocol, the comparative analysis uses the method to be validated (3.1) and the baseline method
(3.2) The test results obtained confirm that the method to be confirmed has sufficient credibility.
3.4
Laboratory confirmed validatedinthelaboratory
Under the guidance of the organization's laboratory or method validation person, treat the confirmation method and the reference party in the method development or use laboratory
The law is compared.
3.5
Interlaboratory interlaboratory colaborativestudy
Several laboratories quantify and test one or more stable, uniform raw materials, with the supporting documentation, and
Assembled into a single file. The guidelines for collaborative experiments are detailed in the draft ISO 5725 and ISO /AOAC/IUPAC protocols.
description.
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