Verification of analytical methods for GMO testing when implementing interlaboratory validated methods
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00027006%3A_____%2F17%3A00004294" target="_blank" >RIV/00027006:_____/17:00004294 - isvavai.cz</a>
Result on the web
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DOI - Digital Object Identifier
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Alternative languages
Result language
angličtina
Original language name
Verification of analytical methods for GMO testing when implementing interlaboratory validated methods
Original language description
In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories.When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs.Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfil legal requirements, then this document will be amended accordingly.This document provides the definitions of the parameters to be assessed by laboratories in a verification study and the related acceptance criteria. Moreover, indications and examples of experimental designs are also described.
Czech name
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Czech description
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Classification
Type
H<sub>neleg</sub> - Results reflected in directives and regulations of a nonlegislative nature, binding within the competence of the given provider
CEP classification
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OECD FORD branch
10603 - Genetics and heredity (medical genetics to be 3)
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Regulation ID
Nařízení Komise (EU) č. 2017/625
Competence designation of competent authority
Komise Evropské unie
Territorial validity of the result
B - Platnost evropská či mezinárodní (předpisy EU, evropské či jiné nadnárodní normy)