NFU 47 301 : 2001
Current
The latest, up-to-date edition.
ANIMAL HEALTH ANALYSIS METHODS - PRESENTATION FILE FOR CONTROL OF BIOLOGICAL REAGENTS USED IN THE ANIMAL HEALTH SECTOR
12-01-2013
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Contenu du dossier pour le controle initial
4.1 Renseignements administratifs
4.1.1 Généralités
4.1.2 Présentation
4.2 Dossier technique du produit
4.2.1 Fabrication
4.2.2 Dossier d'évaluation
4.2.3 Controles de qualité du produit fini
4.3 Bibliographie
5 Contenu du dossier pour le controle lot par lot
5.1 Demande écrite de controle du lot
5.2 Résultats du controle qualité interne du fournisseur
Le présent document s'inscrit dans un ensemble de normes de méthodes d'analyse en santé animale. Il décrit la façon de présenter un dossier pour le controle des réactifs. Le présent document a pour objectif de donner au fournisseur faisant controler un réactif biologique les éléments généraux destinés à l'élaboration de la demande de controle: ils permettent de préparer le dossier de controle.
| DevelopmentNote |
Indice de Classement: U47-301 PR NF U47-301 May 2001 (05/2001)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
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| NFU 47 305 : 2002 | ANIMAL HEALTH ANALYSIS METHODS - REAGENT CONTROL PROTOCOL FOR THE DETECTION OF GE-ANTIBODIES AGAINST THE AUJESZKY DISEASE BY THE ELISA METHOD IN SERUMS (INDIVIDUAL OR MIXED) |
| NFU 47 308 : 2004 | ANIMAL HEALTH ANALYSIS METHODS - CONTROL PROTOCOL FOR REAGENTS FOR DETECTION OF ANTIBODIES DIRECTED AGAINST BRUCELLOSIS BOVINE BY THE ELISA METHOD IN BULK TANK SAMPLES |
| NFU 47 304 : 2004 | ANIMAL HEALTH ANALYSIS METHODS - CONTROL PROTOCOL OF REAGENTS CONTROL PROTOCOL OF REAGENTS FOR THE DETECTION OF ANTIBODIES DIRECTED AGAINST BRUCELLOSIS BY THE ROSE BENGAL TEST, THE COMPLEMENT FIXATION TEST OR THE SEROAGGLUTINATION TEST IN SERUM SAMPLES OR FOR THE DETECTION OF ANTIBODIES DIRECTED AGAINST BOVINE BRUCELLOSIS BY THE RING TEST IN BULK TANK MILK SAMPLES |
| NFU 47 307 : 2004 | ANIMAL HEALTH ANALYSIS METHODS - CONTROL PROTOCOL OF REAGENTS FOR THE DETECTION OF ANTIBODIES DIRECTED AGAINST BOVINE BRUCELLOSIS BY THE ELISA METHOD IN SERA (INDIVIDUAL SERA OR POOLS OF TEN SERA) |
| NFU 47 306 : 2004 | ANIMAL HEALTH ANALYSIS METHODS - REAGENT CONTROL PROTOCOL FOR THE DETECTION OF TOTAL ANTIBODIES (OR GB-ANTIBODIES) AGAINST THE AUJESZKY DISEASE BY THE ELISA METHOD IN SERUMS (INDIVIDUAL OR MIXED) |
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