JAB RL JAB RL358: XX

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4 ( ) JAB JIS Q 17025:2005 (ISO/IEC 17025) JIS Q (ISO/IEC 17025):2005 JIS Q (ISO/IEC 17025):2005 JAB JAB RL355 () JAB RL359 ( ) JAB RL358 () (GMO)/ JIS Q (ISO/IEC 17025):2005 JIS Q (ISO/IEC 17025):2005 ISO 24276:2006 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions CITAC/EURACHEM GUIDE, Guide to Quality in Analytical Chemistry, An Aid to Accreditation, Edition 2002 AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals:2006 GUIDELINES ON PERFORMANCE CRITERIA AND VALIDATION OF METHODS FOR DETECTION, IDENTIFICATION AND QUANTIFICATION OF SPECIFIC DNA SEQUENCES AND SPECIFIC PROTEINS IN FOODS* CAC/GL ISO/TS 21098:2005 Foodstuffs Nucleic acid based methods of analysis of genetically modified organisms and derived products Information to be supplied and procedure for the addition of methods to ISO 21569, ISO or ISO JIS Q 17025(ISO/IEC 17025) JIS Q 17025:2005 JIS Q (ISO/IEC 17025):2005 JAB () / XX

5 JAB ISO 24276:2006 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions ISO/TS 21098:2005 Foodstuffs Nucleic acid based methods of analysis of genetically modified organisms and derived products Information to be supplied and procedure for the addition of methods to ISO 21569, ISO or ISO CAC/GL GUIDELINES ON PERFORMANCE CRITERIA AND VALIDATION OF METHODS FOR DETECTION, IDENTIFICATION AND QUANTIFICATION OF SPECIFIC DNA SEQUENCES AND SPECIFIC PROTEINS IN FOODS* CITAC/EURACHEM GUIDE Edition 2002 JAB CITAC Chairman JAB RL355 AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals:2006 AOAC:2006JAB / XX

6 ISO 24276: Material and reagents CITAC/EURACHEM GUIDE ISO 24276: General Laboratory and procedural requirements 5.1 General 5.2 ISO 24276: Personnel CITEC Guide CITAC/EURACHEM GUIDE / XX

7 CITAC/EURACHEM GUIDE AOAC: CITAC/EURACHEM GUIDE i) ii) iii) OJT( ) iv) /() v) CITAC/EURACHEM GUIDE ISO 24276: Laboratory design ISO 24276: Personnel CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE / XX

8 CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE PCR i) ii) iii) iv) CITAC/EURACHEM GUIDE ISO 24276: Guidance for the user on the selection of methods ISO 24276: Performance characteristics ISO 24276: Table 1 B CAC/GL ANNEX I PRACTICAL APPLICATION OF THE METHOD (27.~30.) CITAC/EURACHEM GUIDE ISO - ISO 21569:2005, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products-qualitative nucleic acid based methods - ISO 21570:2005, Foodstuffs-Methods of analysis for the detection of genetically / XX

9 modified organisms and derived products-quantitative nucleic acid based methods - ISO 21571:2005, Foodstuffs-Methods of analysis for the detection of genetically modified organisms and derived products-nucleic acid extraction - ISO 21572:2004, Foodstuffs-Methods for the detection of genetically modified organisms and derived products-protein based methods - ISO/TS 21098:2005, Foodstuffs-Nucleic acid based methods of analysis of genetically modified organisms and derived products-information to be supplied and procedure for the addition of methods to ISO 21569, ISO or ISO ~ ISO 24276: ISO/TS 21098: CAC/GL SECTION 1 INTRODUCTION ( ) CAC/GL SECTION 1.1 PURPOSE AND OBJECTIVES (4. 5.) CAC/GL SECTION 1.2 SCOPE (6.) CAC/GL SECTION 2 METHOD VALIDATION (7.) CAC/GL Section 2.1 Criteria Approach (8.) CAC/GL Section 2.2 General Method Criteria (9.) CAC/GL Section 2.3 Validation Process ( ) CAC/GL Section Modular Approach to Method Validation ( ) CAC/GL Section General Information ( ) CAC/GL Section Minimum Performance Requirements ( ) CAC/GL Section Collaborative Trial Test Materials (33. 34) CAC/GL ANNEX I DESCRIPTION OF THE METHOD (1.~5.) CAC/GL ANNEX I SPECIFIC INFORMATION REQUIRED FOR DNA-BASED METHODS (6.) CAC/GL ANNEX I Primer pairs (7.) CAC/GL ANNEX I Amplicon length(8) CAC/GL ANNEX I SPECIFIC INFORMATION REQUIRED FOR PROTEIN-BASED METHODS (14.~17.) CAC/GL ANNEX I INFORMATION ABOUT THE METHOD PERFORMANCE / XX

10 ( ) CAC/GL ANNEX I PRACTICAL APPLICATION OF THE METHOD ( ) ISO 24276: Performance characteristics CAC/GL Section 3.1 Method Development to Formal Validation (12) CAC/GL Section Method Acceptance Criteria (Required condition for validation) CAC/GL Section Applicability of the Method ( ) CAC/GL Section Principle condition ( ) CAC/GL Section Specific Information on the Validation of Methods (35. 36) CAC/GL Section Measurement Uncertainty ( ) , CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE / XX

11 , CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE i) ii) PCR iii) iv) ISO 24276: Apparatus and equipment CAC/GL ANNEX I whether the method is instrument or chemistry specific ( ) CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE / XX

12 CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE A CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE A CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE / XX

13 CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE ph CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE SI SI CITAC/EURACHEM GUIDE / XX

14 (ISO 35:C6 ) CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE / XX

15 CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE / XX

16 JAB CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE CITAC/EURACHEM GUIDE AOAC: ISO/IEC 24276: Interpretation of controls ISO/IEC 24276: Quality assurance requirements CAC/GL Section 4 QUALITY CONTROL REQUIREMENTS ( ) CAC/GL ANNEX I SPECIFIC INFORMATION REQUIRED FOR PROTEIN-BASED METHODS (14.~17.) CAC/GL ANNEX I INFORMATION ABOUT THE METHOD PERFORMANCE ( ) CAC/GL ANNEX I ANALYTICAL CONTROLS ( ) CAC/GL ANNEX I METHOD PERFORMANCE (33.) / XX

17 , ISO/IEC 24276: Use of controls CITAC/EURACHEM GUIDE QC CITAC/EURACHEM GUIDE QC QC QC CITAC/EURACHEM GUIDE QC QC CITAC/EURACHEM GUIDE QC QC QC QC QC CITAC/EURACHEM GUIDE QC 20 QC QC 20% 50 QC CITAC/EURACHEM GUIDE QC / XX

18 C7 CITAC/EURACHEM GUIDE C7 ISO/IEC Guide43 B16 ILAC G ISO 24276: Interpretation and expression of results 6.1 General ISO 24276: Expression of a negative result ISO 24276: Expression of a positive result ISO 24276: Expression of ambiguous result CAC/GL Section Unit of Measurement and reporting of results (21. 22) ISO/IEC 24276: Test report CITAC/EURACHEM GUIDE ISO/IEC 24276: Test report / XX

19 A A / XX

20 A (a) (b) (a) (b) (a) (b) (a) (b) (a) 2 (b) (a) 2 (b) (a) 2 (b) (a) 1 (b) ph 2 ( ) (a) (b) (b) / XX

21 PCR (a) (b) (a) (b) (a) (b) (c) / (a) (b) (c) ( ) (accuracy) (trueness) (precision) ( JIS K 0211:2005 ) / XX

22 JAB RL358: B ISO 24276:2006 Table Control step b Environment Control Flow diagram showing intersection between successive steps and inclusion of controls c Extraction blank control d Positive extraction control DNA e Positive DNA target control DNA Negative DNA target control g Amplification reagent control PCR PCR inhibition control h Homogenization recommended Nucleic acid extraction a One per series Mandatory at regular intervals Assessment of nucleic acid quality Nucleic acid amplification Assessment of results of nucleic acid amplification Interpretation mandatory recommended mandatory i recommended, but mandatory in certain cases Test report : / XX

23 JAB RL358:2013 a The arrows indicate that this control should be applied in the subsequent analytical steps. b The use of environment controls will help the laboratory to identify sources of contamination at an early stage and can even be used to identify in which work area the contamination is present. c DNA At least one extraction blank control shall be included each time DNA is extracted from one or more samples. The tube shall always be the last in each series. It may be appropriate to put one extraction blank on e. g. a rack of eight tubes or a microplate of 96 wells for automated extraction. d A positive extraction control should be included regularly, and always when a new batch of extraction reagents is used. This control will reveal if something is wrong with the reagents or the performance of the extraction of the extraction protocol. e DNA GMO target taxon The positive DNA target control demonstrates the ability of the nucleic acid amplification procedure to detect the nucleic acid representative of the GMO or target taxon. This condition can also be fulfilled by an appropriate positive extraction control. f DNA GMO target taxon The negative DNA target control demonstrates the ability of the nucleic acid amplification procedure to avoid false positive amplification in the absence of the nucleic acid representative of the GMO or target taxon. g PCR The amplification reagent control demonstrates the absence of contaminating nucleic acid in the PCR reagent batches used. The amplification reagent control can be omitted when the extraction blank control is used. h PCR The PCR inhibition control may be used to demonstrate the absence of soluble inhibitors. This may also be demonstrated by serial dilutions of the template nucleic acid. However, some type of assessment of the effect of soluble inhibitors on the results of the analysis of the sample shall be made. i PCR DNA PCR A PCR-inhibition control is mandatory, if all PCR-tests on the sample are negative and for matrices where the yield of amplifiable DNA is not known. : / XX

24 JAB RL358: C ISO 24276: Interpretation of controls Each control has a valid value and, if the observed result for any control is different from the valid value, the analysis shall be repeated. Environmental controls may be positive (amplification product of expected size detected) or negative (no amplification product detectable), but a positive result shall always initiate measures to remove and prevent contamination of the laboratory environment. If a non-valid result for any of the other controls is obtained repeatedly, measures shall be taken to locate and remove/replace the source(s) responsible for the error, and the analysis then repeated. Analytical results shall only be reported when all controls yield valid values. The valid values for the controls are as follows: - positive extraction controls shall always be positive; - - extraction blank controls shall always be negative; - DNA positive DNA target controls shall always be positive; - DNA negative DNA target controls shall always be negative; - amplification reagent controls shall always be negative. PCR ( : / XX

25 JAB RL358: ) PCR-inhibition controls shall not show significant inhibitory effects on the reaction (for qualitative analysis, the effect of inhibition may be less important than for quantitative analysis). PCR Possible PCR results of the controls are listed in Table 2. These are used for interpreting/reporting the test sample result. : / XX

26 JAB RL358: PCR Test sample Positive extraction control Extraction blank control DNA Negative DNA target control DNA Positive DNA target control + a b a PCR PCR product is detectable. Interpreted result positive negative c inconclusive c inconclusive d inconclusive b PCR No PCR product is detectable. c The procedure is repeated beginning with the extraction step (possible contamination). 722 d The procedure is repeated using another extraction method or a further purification step (possible inhibition). : / XX

27 JAB RL358: JAB NF18 REV JIS Q XX PM () : / XX

28 JAB RL358: AN 3F Tel Fax : / XX

JIS Z 9001:1998JIS Z 9002:1998 ISO/IEC 17025ISO/IEC Guide 25

JIS Q 17025 IDT, ISO/IEC 17025 IT JIS Z 9001:1998JIS Z 9002:1998 ISO/IEC 17025ISO/IEC Guide 25 JIS Q 17025 IDT, ISO/IEC 17025 IT IT JIS Q 17025ISO/IEC 17025 (2) JIS Z 9358 ISO/IEC Guide 58 (3) testing