Verification of analytical methods for GMO testing when implementing interlaboratory validated methods

Kód výsledku v 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>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Verification of analytical methods for GMO testing when implementing interlaboratory validated methods

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

Verification of analytical methods for GMO testing when implementing interlaboratory validated methods

Popis výsledku anglicky

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.

Druh

H_neleg - Promítnuto do směrnic nebo předpisů závazných v rámci příslušného poskytovatele

CEP obor

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OECD FORD obor

10603 - Genetics and heredity (medical genetics to be 3)

Projekt

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Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Číslo předpisu

Nařízení Komise (EU) č. 2017/625

Označení kompet. příslušného orgánu

Komise Evropské unie

Územní platnost výsledku

B - Platnost evropská či mezinárodní (předpisy EU, evropské či jiné nadnárodní normy)