What's Next Regarding Validation And Verification: Overview Of ISO .
What’s Next RegardingValidation and Verification:Overview of ISO 16140 SeriesPresented By: Paul in’t Veld, DeAnn Benesh, Daniele SohierSponsored By: Bruker Daltonics and Q LaboratoriesOrganized by: Methods Validation & Verification Interest Groupwithin the Applied Laboratory Methods PDG
Webinar Housekeeping For best viewing of the presentation material, pleaseclick on ‘maximize’ in the upper right corner of the ‘Slide’window, then ‘restore’ to return to normal view. Audio is being transmitted over the computer, so pleasehave your speakers ‘on’ and volume turned up in orderto hear. A telephone connection is not available. Questions should be submitted to the presenters duringthe presentation via the Questions section at the right ofthe screen.
Webinar Housekeeping It is important to note that all opinions and statementsare those of the individual making the presentation andnot necessarily the opinion or view of IAFP. This webinar is being recorded and will be available foraccess by IAFP members at www.foodprotection.orgwithin one week.
Paul in ‘t VeldSenior Scientist – Netherlands Food andConsumer Product Safety Authority (NVWA) Main responsibilities involve support of inspectorson microbiological issues and standardization ofmethods. Serves as a technical assessor for laboratorieshaving an ISO 17025 accreditation in severalcountries Convener of ISO WG3 which involves revision of ISO16140, validation of alternative methods Involved in research related to bacterial toxins suchas the emetic toxin for Bacillus cereus
DeAnn L. BeneshGlobal Regulatory Affairs Manager – 3M Food Safety Leads regulatory activities with government and nongovernment entities to help drive harmonization,recognition and acceptance of microbiological methods Member of MicroVal General Committee Active member of IAFP International and Food LawPDGs Co-chair of WG3 drafting ISO 16140-part 3 Fellow of AOAC INTERNATIONAL and past Chair of theResearch Institute Board of Directors Currently serves on AOAC Board of Directors as PastPresident
Daniele SohierBruker Daltonics, Germany Managed the AOAC and ISO validation studies ofalternative methods at ADRIA expert laboratory(FR) for more than 10 years and over 100 studiesJoined Bruker two years ago to design andcoordinate the very first AOAC-OMA and ISO16140-part 6 studies of a MALDI-TOF technologyfor rapid and reliable confirmation andidentification of microbial isolatesMember of the AFNOR Certification committeeand MicroVal technical and general committeesCurrent President of the European IAFP event andhas organized more than 20 symposia, workshopsor international conferences and has more than100 international publications or communications
IAFP webinar:What's Next RegardingValidation and Verification:Overview of ISO 16140Series:IntroductionPaul in ‘t Veld, convenor WG3
Standards under responsibility WG 3-WG3 belongs to ISO TC34/SC9: food microbiology.WG 3 started in 2006.Mandate:- Update ISO 16140 (2003): Validation of alternative (proprietary)methods- Develop standards on:- Validation of standardised methods,- Single lab validation,- Factorial design validation,- Method verification and- Validation of confirmation methods
Standards under responsibility WG 3-Validation of standardized methods (ISO 17468) described the rulesfor validation or re-validation of standardized (ISO or CEN) methods.Based on principles described in ISO 16140-2.-Single lab validation describes the validation against a referencemethod or without a reference method using a classical approach or afactorial design approach. Validation results are only valid in the lab thatperformed the validation.-Factorial design validation describes the validation using ainterlaboratory study based on factorial design approach.
Current status of the standards-ISO 16140-1: Vocabulary. Published in July 2016ISO 16140-2: Protocol for the validation of alternative (proprietary) methods.Published in July 2016.ISO 17468: Technical requirements and guidance on establishment or revisionof a standardized reference method. Published in July 2016.ISO 16140-3: Protocol for the verification of reference and validatedalternative methods implemented in a single laboratory. FDIS in preparation.ISO 16140-4: Protocol for method validation in a single laboratory. FDIS inpreparation.ISO 16140-5: Protocol for factorial interlaboratory validation for nonproprietary methods. FDIS in preparation.ISO 16140-6: Protocol for the validation of alternative (proprietary) methodsfor microbiological confirmation and typing procedures. FDIS in preparation.
Basic question in yellow:
Method not validated
Method validated
ISO/DIS 16140 Microbiology of the Food Chain –Method Validation – Part 3:Protocol for the verification of reference and validated alternative methodsimplemented in a single laboratoryDeAnn Benesh, 3M Food Safety Co-Chair ISO 16140-3 (w/Benjamin Diep, Nestle)
Method Validated?
Distinguishing Validation & Verification (ISO 16140-1:2016)Validation (Clause 2.81) Establishment of the performance characteristics of a methodand provision of objective evidence that the performancerequirements for a specified intended use are fulfilledVerification (Clause 2.83) Demonstration that a validated method functions in the user’shands according to the method’s specifications determined in thevalidation (2.81) study and is fit for its purpose
Published Documents on VerificationUS FDA FDA Bacteriological Analytical Methods (BAM) Appendix 3;Section 4Health Products and Food Branch (HPFB) ofHealth Canada Compendium of Methods – Volume 1, Development ofMethods “Click” on the link and send an email to request an emailedcopy
ISO 16140-2:2016Table A. 1: Classification of sample types & suggested target combinations forvalidation studiesCATEGORIESRaw Milk &DairyProductsHeatProcessedMilk & DairyProductsRaw meat &Ready-to-cookmeat products(exceptpoultry)Ready-to-eat,ready-toreheat meatproductsRaw Poultry &ready-to-cookpoultryproductsEggs & eggproducts(derivatives)Raw & readyto-cook fish &seafoods(unprocessed)Ready-to-eat,ready-toreheat fisheryproductsFresh produce Processed& fruitsfruits &vegetablesDried cereals,fruits, nuts,seeds andvegetablesInfantformula &infantcerealsChocolate,bakeryproducts &confectionaryMulticomponentfoods or lsamples (foodor feedproduction)Pet food &animal feedReady-to-eat,ready-toreheat meatpoultryproducts
How many samples to test for Verification?
Number of Samples to Test? BIG Debates!15 food categoriesclaimed x 5 foods/category is 75 foodsneeded Verification!!!That’s way toomuch!Only ONE Matrixis needed Verification!!!
Overlap Between Scopes“Broad Range of Foods”Or – only specific categories?Categories ValidatedRoutinely Tested in User Lab
Verification 2 Step Procedure1) Implementation Verification:Demonstrate the competence of the user laboratory toperform the method2) (Food) item Verification : Demonstrate the competence of the user laboratory toperform the method with (food) items routinely tested inthe user laboratory
Implementation1) Implementation Verification:Demonstrate the competence of the user laboratory toperform the method25
(Food) item2) (Food) item Verification : Demonstrate the competence of the user laboratory toperform the method with (food) items routinely tested inthe user laboratory26
Overlap Between Scopes“Broad Range of Foods”Or – only specific categories?Categories ValidatedRoutinely Tested in User Lab
(Food) Item Verification – Broad Range of Foods
(Food) Item – Limited Range of Foods
Acceptance criteria in verificationInter-Laboratory study required ISO 16140-2 and AOAC OMA methods30
ISO 16140 SeriesISO has recognized several ISO 16140 documents as“high profile” because they believe the global foodindustry has a great need for these documents: ISO 16140-2 Method Validation - PublishedAugust 2016 ISO 16140-3 Method Verification – Expectedpublication 2019Decision to gather input from USER LABORATORIES, vsjust WG3 Experts31
Acceptance Criteria defined BEFORE starting Responses from 30 global laboratories Various lab sizes Global regions (including Africa/Middle East if possible) Industry, Contract, Government ALL responses to the questionnaire rated 3 on a 1-5scale 75 % of the user laboratories are able to follow and understand ISO/CD 16140-3 for those that attempted, are able to conduct a verificationRequest to SC9 30 labs; Further recruiting 60 labs
User Laboratory Response52 of 60 labs responded 80% response rate!33
User Laboratory Participation34
User Laboratory Evaluation: Text ComprehensionGeneral100959085Acceptance criteria:75% 3 tion Type verification Performanceverifictaioncharacteristics35
User Laboratory Evaluation: Text ComprehensionQualitative Methods1009590858075706560Acceptance criteria:75% 3 (neutral)555036
User Laboratory Evaluation: Text Comprehension110Quantitative Methods100908070Acceptance criteria:75% 3 (neutral)605037
User Laboratory Evaluation: PracticeVerification on site908580Acceptance criteria:75% 3 (neutral)757065605550ImplementationeLOD5018 labsImplementation eBias Implementation SIR11 labs11 labsType verificationeLOD50Type verificationeBias14 labs10 labs38
Publications Expected – End of 2019ISO 16140-3 Document 35 pages Protocol 35 pages Annexes with examplesTransition Document: Guidance on transition to meet ISO 17025requirements: For Labs, Assessors (Technical), Accreditation Bodies Methods currently under scope of Lab ISO 17025accreditation: Methods under the scope of the accreditation of the laboratoryfor which verification has already been conducted do not needto re-verify their methods according to ISO 16140-339
40
ISO 16140-part 6Protocol for the validation of alternative(proprietary) methods for microbiologicalconfirmation and typing proceduresDaniele Sohier, Business Developement Manager – Industrial Microbiology, GermanyNovember 1, 2018
ISO 16140 for the validation ofalternative (proprietary) methodsTimeline (1/2) 2003Publication of the ISO 16140 standard - Protocol for thevalidation of alternative methods 2006Revision of the ISO 16140 2016Publication ISO 16140–part 1: Vocabulary ISO 16140–part 2: Protocol for the validation of alternative(proprietary) methods against a reference method1. Alternative (proprietary) methods for the detection and enumeration of specificmicroorganisms are validated according to the ISO 16140 standard since 15 years2. This ensures the recognition of the validated methods by regulation bodies (e.g. EU2073/2005, FDA) and facilitate the accreditation process by the end-users3. These alternative methods enable usually time- and cost- saving, and are easy-to-use What about the validation and recognition of confirmation and typing methods?November 1, 201842
ISO 16140 for the validation ofalternative (proprietary) methodsTimeline (2/2) 2003Publication of the ISO 16140 standard - Protocol for thevalidation of alternative methods 2006Revision of the ISO 16140 2016Publication ISO 16140–part 1: Vocabulary ISO 16140–part 2: Protocol for the validation of alternative(proprietary) methods against a reference method 2018November 1, 2018Pre-FDIS of the ISO 16140-part 6: Protocol for the validationof alternative (proprietary) methods for microbiologicalconfirmation and typing procedures43
ISO 16140-6Final stage before publicationPublication in 2018 after translation in French and GermanNovember 1, 201844
ISO 16140-6General principles (1/4)SampleThe sample is a microbial isolateon a specific culture mediumTherefore, the culture mediatested during the validation shallbe clearly definedPhoto kindly provided by Bio-RadNovember 1, 201845
ISO 16140-6General principles (2/4)WorkflowScreening step, i.e.detection or enumerationIsolation ondefined culturemedia Reference method, e.g.ISO or FDA method Alternative methodvalidated according to theISO 16140-2 standardNovember 1, 2018Confirmation or Typing Reference methodprotocol, e.g. ISO or FDAmethod Proprietary protocol testedduring the ISO 16140-2validation of the screeningmethod Alternative methodvalidated according tothe ISO 16140-part 6standard for definedculture mediaXLDBGAXLDHektoen 46
ISO 16140-6General principles (3/4)Study requirementsAcceptability Limits (AL)ISO 16140-6 study The testing and datainterpretation SHALL beconducted by an expert(independant) laboratory The data generated bythe alternative methodare compared to thereference method, e.g.ISO or FDA confirmationprocedureNovember 1, 2018 maximum positive ornegative acceptabledifference between thereference value (or if notknown, the acceptedreference value) of asample and an individualresult obtained whenapplying the operatingprocedure of an analyticalmethodInterpretationAcceptedRejected47
ISO 16140-6General principles (4/4)Study processMethod Comparison study on numerous- target strains inclusivity testing- non-target strains exclusivity testingTo assess the reliability of the methodInter-laboratory study with a restrictednumber of target and non-target strains toassess the reproducibility of the method withdifferent operators, instruments, materialsNovember 1, 2018Expertlaboratory(third party)Minimum 10valid data setsfrom differentcollaborators48
ISO 16140-part 6Method Comparaison Study (1/4)Selection of test strains1. Each strain shall be characterized biochemically and/or serologically and/orgenetically in sufficient detail for its identity to be known.2. Strains used should preferentially have been isolated from foods, feeds,the food-processing environment, or primary production taking intoaccount the scope of the validation.However, clinical, environmental, and culture collection strains can be used.3. The original source of all isolates should be known and they should beheld in a local (e.g. expert laboratory), national, or international culturecollection to enable them to be used in future testing, if required.November 1, 201849
ISO 16140-part 6Method Comparaison Study (2/4)Inclusivity and Exclusivity TestingThe panel of strains shall be isolated on the tested culture mediaTarget analyteInclusivity panel ( )Exclusivity panel (-)Family levele.g. Enterobacteriacea 200 strains 100 strainsGenus levele.g. Listeria spp. 150 strains 100 strains*Species levele.g. L. monocytogenes Usually 100 strains150 strains forSalmonella spp. 100 strainsincluding 50 strainsfrom the samegenus*Typing levele.g. Salmonella serotypes 25 strains per type 100 strainsincluding 75 strainsfrom the non-targettypes*See special design for Salmonella spp.e.g. Genus level with 5 selective media 1 non-selective agar6 media x (150 100) strains 1 500 testsNovember 1, 201850
ISO 16140-part 6Method Comparaison Study (3/4)InterpretationInclusivityRoot cause nRef / AltIdentity ofstrainFinalInterpretation PANot requiredIA -ND FN ? ID-a aPD FP? IA-a-aNANot hodComparaisonRef / AltIdentity ofstrainFinalInterpretation--NANot requiredEA- PD FP ?-ED a-aND FN?-EA a aPANot requiredEAanotbe very likely to be foundP: Positive N: Negative D: Deviation A: Agreement F: False I: Inclusivity E: ExclusivityNovember 1, 201851
ISO 16140-part 6Method Comparaison Study abilityInclusivityIAIDID ALExclusivityEAEDED ALExample: Genus level, Inclusivity 150 strains , Exclusivity 100 lusivityIA 150/150ID 0/15010 1 ExclusivityEA 97/100ED 3/10023 2 D: Deviation A: Agreement F: False I: Inclusivity E: Exclusivity AL: Acceptability LimitNovember 1, 201852
ISO 16140-6General principles (4/4)Study processMethod Comparison study on numerous- target strains inclusivity testing- non-target strains exclusivity testingTo assess the reliability of the methodInter-laboratory study with a restrictednumber of target and non-target strains toassess the reproducibility of the method withdifferent operators, instruments, materialsNovember 1, 2018Expertlaboratory(third party)Minimum 10valid data setsfrom differentcollaborators53
ISO 16140-part 6Inter-Laboratory Study (1/1)Study Design and InterpretationNumber ofblind-coded strains Inclusivity: 16 Exclusivity: 8Number of valid data sets 10 valid data sets minimum 5 differentorganizationsInterpretationwithID, ED and AL ALAcceptedRejectedNovember 1, 201854
Proof of ConceptISO 16140-6GeneralFood SafetyCommittee AuthoritiesFVSTNVWA*Food SafetyTechnicalCommittee AuthoritiesFDA*FVSTNVWA*Certification andstandardization bodiesLaboratoriesand usersManufacturersAOAC*NMKLLoyd’sADRIA*Campden rmMerckCertification andstandardization bodiesLaboratoriesand usersManufacturersLoyd’sADRIA*Campden teconBruker*MerckWebinar orgnization*Organizations involved in the ISO working group on the ISO 16140 seriesNovember 1, 201855
Validation of a confirmation method according to ISO/DIS 16140-6:2017A MicroValpilot pilotstudyusingtheMALDIBiotyperA MicroValusing theMALDIBiotyperstudyas an alternativeforforSalmonellaconfirmationas an alternativeSalmonella spp.spp.confirmationB. Bastin1, P. Bird1, E. Crowley1, B. Diep2, I. Ferro3, T. Hammack4, W. Jacobs5, M. Kostrzewa6, C. LeDoeuff7, S. Peron7, M. Rannou7, D. Sohier6, M. Timke6, P. in ’t Veld8, J. Witsenburg3The ISO 16140 standard provides technical andinterpretation rules for method validation andverification, and consists of 6 different parts. Part 6is currently at the DIS (Draft International Standard)stage and describes the protocol for the obiological confirmation and typing procedures.The study design was set up during the past years,and acceptability limits for the data interpretationwere defined based on expert opinion, i.e.maximum number of positive or negative deviationsbetween the reference and alternative method.Evaluation of the ISO/DIS 16140-6:2017: Do thetechnical rules give sufficient detail to conduct themethod comparison and inter-laboratory studies?Are the proposed acceptability limits (AL) fit forpurpose or too restrictive? A pilot study wascoordinated by MicroVal as a proof of concept.The MALDI Biotyper (Bruker) was tested as analternative to confirm Salmonella spp. from nonselective and selective agars. A method comparisonand an inter-laboratory studies were realized. 150Salmonella spp. strains and 100 non-target strainswere tested by two expert laboratories in themethod comparison study. The collaborative studywas run by involving a minimum of 10 organizationsto produce 10 valid data sets with 16 target and 8non-target strains.See Tables 1 and 2, with the Tested strains (N),Deviation (D) and Acceptability Limit (AL).TABLE 1: Summary of the Method Comparison StudyTestedMediaNutrientAgarTested Panelof onella ExclusivityInclusivityBrillianceSalmonella tedAcceptedAcceptedAcceptedAcceptedTABLE 2: Summary of the Inter-Laboratory StudyTestedMedia & Tested PanelNumber ofof StrainsLabsNutrientInclusivityAgar Exclusivity14 LabsInclusivityXLD13 ity12 eptedAcceptedAcceptedAcceptedThe MicroVal reviewers and the expert laboratories encountered no specific difficulties in setting up theproject, organizing the testing, and interpreting the generated data. The collaborating laboratories couldeasily understand the protocol of the ISO/DIS 16140-6:2017 and achieve the required number of tests. Thedefined AL were easily passed as all the Salmonella spp. strains were correctly confirmed with the MALDIBiotyper on all tested media in the method comparison and inter-laboratory studies.The ISO/DIS 16140-6:2017 provides valuable technical rules and interpretation concept to validateconfirmation methods. The observed results were excellent; therefore Microval issued a certificate ofvalidation based on the ISO/DIS 16140-6:2017. The certificate is available on www.microval.org.1Q-Laboratories, 2NestléResearch Center, 3MicroVal, 4FDA,& project leader of the ISO 16140-part 6, 6BRUKER,7ADRIA, 8VWANovember1, 2018 of the ISO 16140 working group& convenorProof of ConceptBastin1, P. Bird1, E. Crowley1,B. Diep2, I. Ferro3, T. Hammack4, W.Jacobs5, M. Kostrzewa6,C. Le Doeuff7, S. Peron7,M. Rannou7, D. Sohier6, M. Timke6, P. in ’tVeld8, J. Witsenburg31Q-Laboratories, 2NestléResearch&Center,project leader of the ISO 16140-part6, 6BRUKER, 7ADRIA, 8VWA &convenor of the ISO 16140 workinggroup3MicroVal, 4FDA, 5RIVM5RIVM56
Validation of a confirmation method according to ISO/DIS 16140-6:2017A MicroVal pilot study using the MALDI Biotyperas an alternative for Salmonella spp. confirmationB. Bastin1, P. Bird1, E. Crowley1, B. Diep2, I. Ferro3, T. Hammack4, W. Jacobs5, M. Kostrzewa6, C. LeDoeuff7, S. Peron7, M. Rannou7, D. Sohier6, M. Timke6, P. in ’t Veld8, J. Witsenburg3The ISO 16140 standard provides technical andinterpretation rules for method validation andverification, and consists of 6 different parts. Part 6is currently at the DIS (Draft International Standard)stage and describes the protocol for the obiological confirmation and typing procedures.The study design was set up during the past years,and acceptability limits for the data interpretationwere defined based on expert opinion, i.e.maximum number of positive or negative deviationsbetween the reference and alternative method.Evaluation of the ISO/DIS 16140-6:2017: Do thetechnical rules give sufficient detail to conduct themethod comparison and inter-laboratory studies?Are the proposed acceptability limits (AL) fit forpurpose or too restrictive? A pilot study wascoordinated by MicroVal as a proof of concept.The MALDI Biotyper (Bruker) was tested as analternative to confirm Salmonella spp. from nonselective and selective agars. A method comparisonand an inter-laboratory studies were realized. 150Salmonella spp. strains and 100 non-target strainswere tested by two expert laboratories in themethod comparison study. The collaborative studywas run by involving a minimum of 10 organizationsto produce 10 valid data sets with 16 target and 8non-target strains.See Tables 1 and 2, with the Tested strains (N),Deviation (D) and Acceptability Limit (AL).TABLE 1: Summary of the Method Comparison StudyTestedMediaNutrientAgarTested Panelof onella ExclusivityInclusivityBrillianceSalmonella tedAcceptedAcceptedAcceptedAcceptedProof of ConceptTABLE 2: Summary of the Inter-Laboratory StudyTestedMedia & Tested PanelNumber ofof StrainsLabsNutrientInclusivityAgar Exclusivity14 LabsInclusivityXLD13 ity12 edAcceptedAcceptedAccepted096The MicroVal reviewers and the expert laboratoriesencountered no specific difficulties inTheMicroVal reviewersand the project,expert laboratoriesencountered no specificdifficultiesin setting upthesettingup theorganizingthetesting,andinterpreting the generated data. Theproject, organizing the testing, and interpreting the generated data. The collaborating laboratories couldeasilyunderstand the protocol ofthe ISO/DIS 16140-6:2017couldand achieve easilythe required numberof tests. Thecollaboratinglaboratoriesunderstandthe protocol of the ISO/DIS 16140defined AL were easily passed as all the Salmonella spp. strains were correctly confirmed with the MALDIBiotyperon all testedmediain the method thecomparisonand inter-laboratorystudies. of tests. as all the Salmonella spp. strains edwithtechnicalthe MALDIBiotyperonto alltested media in the method comparisonTheISO/DIS 16140-6:2017provides valuablerules and interpretationconceptvalidateconfirmation methods. The observed results were excellent; therefore Microval issued a certificate ofand inter-laboratory studies.validation based on the ISO/DIS 16140-6:2017. The certificate is available on www.microval.org.1Q-Laboratories, 2NestléResearch Center, 3MicroVal, 4FDA,& project leader of the ISO 16140-part 6, 6BRUKER,7ADRIA, 8VWANovember1, 2018 of the ISO 16140 working group& convenor5RIVM57
Validation of a confirmation method according to ISO/DIS 16140-6:2017A MicroVal pilot study using the MALDI Biotyperas an alternative for Salmonella spp. confirmationB. Bastin1, P. Bird1, E. Crowley1, B. Diep2, I. Ferro3, T. Hammack4, W. Jacobs5, M. Kostrzewa6, C. LeDoeuff7, S. Peron7, M. Rannou7, D. Sohier6, M. Timke6, P. in ’t Veld8, J. Witsenburg3The ISO 16140 standard provides technical andinterpretation rules for method validation andverification, and consists of 6 different parts. Part 6is currently at the DIS (Draft International Standard)stage and describes the protocol for the obiological confirmation and typing procedures.The study design was set up during the past years,and acceptability limits for the data interpretationwere defined based on expert opinion, i.e.maximum number of positive or negative deviationsbetween the reference and alternative method.Evaluation of the ISO/DIS 16140-6:2017: Do thetechnical rules give sufficient detail to conduct themethod comparison and inter-laboratory studies?Are the proposed acceptability limits (AL) fit forpurpose or too restrictive? A pilot study wascoordinated by MicroVal as a proof of concept.The MALDI Biotyper (Bruker) was tested as analternative to confirm Salmonella spp. from nonselective and selective agars. A method comparisonand an inter-laboratory studies were realized. 150Salmonella spp. strains and 100 non-target strainswere tested by two expert laboratories in themethod comparison study. The collaborative studywas run by involving a minimum of 10 organizationsto produce 10 valid data sets with 16 target and 8non-target strains.See Tables 1 and 2, with the Tested strains (N),Deviation (D) and Acceptability Limit (AL).TABLE 1: Summary of the Method Comparison StudyTestedMediaNutrientAgarTested Panelof onella ExclusivityInclusivityBrillianceSalmonella tedAcceptedAcceptedAcceptedAcceptedProof of ConceptTABLE 2: Summary of the Inter-Laboratory StudyTestedMedia & Tested PanelNumber ofof StrainsLabsNutrientInclusivityAgar Exclusivity14 LabsInclusivityXLD13 ity12 eptedAcceptedAcceptedAcceptedThe MicroVal reviewers and the expert laboratories encountered no specific difficulties in setting up theproject, organizing the testing, and interpreting the generated data. The collaborating laboratories couldeasily understand the protocol of the ISO/DIS 16140-6:2017 and achieve the required number of tests. Thedefined AL were easily passed as all the Salmonella spp. strains were correctly confirmed with the MALDIBiotyper on all tested media in the method comparison and inter-laboratory studies.The ISO/DIS 16140-6:2017 provides valuable technical rules and interpretation concept tovalidate confirmation methods. The observed results were excellent; therefore Microval issuedThe16140-6:2017valuable technicalrules onand interpretationconcept to16140-6:2017.validatea ISO/DIScertificateofprovidesvalidationbasedthe ISO/DISconfirmation methods. The observed results were excellent; therefore Microval issued a certificate ofThe basedcertificateavailableon iswww.microval.orgvalidationon the ISO/DIS is16140-6:2017.The certificateavailable on www.microval.org.1Q-Laboratories, 2NestléResearch Center, 3MicroVal, 4FDA,& project leader of the ISO 16140-part 6, 6BRUKER,7ADRIA, 8VWANovember1, 2018 of the ISO 16140 working group& convenor5RIVM58
MALDI BiotyperISO 16140-Part 6 CertificationISO/DIS 16140-6: document available on the ISO website,accepted with 100% positive votes during the public enquiry No major modificationsNovember 1, 201859
MALDI BiotyperISO 16140-Part 6 CertificationCertificate n 2017LR72Confirmation of Cronobacter spp.by the Bruker MALDI Biotyper methodNumber of accreditedlaboratoriesCertificate n 2017LR73Confirmation of Salmonella spp.by the Bruker MALDI Biotyper methodCertificate n 2017LR74Confirmation of Campylobacter spp.by the Bruker MALDI Biotyper methodCertificate n 2017LR75Confirmation of Listeria spp. andListeria monocytogenesby the Bruker MALDI Biotyper methodNovember 1, 201860
Questions?Slides and a recording of this webinar will be available for access byIAFP members at www.foodprotection.org within one week.
Validation of standardized methods (ISO 17468) described the rules for validation or re-validation of standardized (ISO or CEN) methods. Based on principles described in ISO 16140-2. -Single lab validation . describes the validation against a reference method or without a reference method using a classical approach or a factorial design approach.
Cleaning validation Process validation Analytical method validation Computer system validation Similarly, the activity of qualifying systems and . Keywords: Process validation, validation protocol, pharmaceutical process control. Nitish Maini*, Saroj Jain, Satish ABSTRACTABSTRACT Sardana Hindu College of Pharmacy, J. Adv. Pharm. Edu. & Res.
Dipl.-Ing. Becker EN ISO 13849-1 validation EN ISO 13849-2: Validation START Design consideration validation-plan validation-principles documents criteria for fault exclusions faults-lists testing is the testing complete? Validation record end 05/28/13 Seite 4 Analysis category 2,3,4 all
Pharmaceutical Engineers (ISPE) GAMP 5. Our validation service is executed in accordance with GxP standards producing a validation library that features the following documents: Validation and Compliance Plan The Validation and Compliance Plan (VCP) defines the methodology, deliverables, and responsibilities for the validation of Qualer.
heard. These goals relate closely to the Validation principles. Validation Principles and Group Work The following eleven axioms are the Validation Principles as revised in 2007. I have tried to find various ways of incorporating the principles into teaching Group Validation and by doing so, anchoring group work to theory. 1.
contents of the tool box" used for validation. The methods and techniques listed in the report are grouped as - review - models - analysis - dynamic methods - methods regarding formality - development methods The validation methods have to be combined together in a validation plan. The plan shall list requirements and validation methods.
contents of the tool box" used for validation. The methods and techniques listed in the report are grouped as - review - models - analysis - dynamic methods - methods regarding formality - development methods The validation methods have to be combined together in a validation plan. The plan shall list requirements and validation methods.
Independent Personal Pronouns Personal Pronouns in Hebrew Person, Gender, Number Singular Person, Gender, Number Plural 3ms (he, it) א ִוה 3mp (they) Sֵה ,הַָּ֫ ֵה 3fs (she, it) א O ה 3fp (they) Uֵה , הַָּ֫ ֵה 2ms (you) הָּ תַא2mp (you all) Sֶּ תַא 2fs (you) ְ תַא 2fp (you
Abrasive Water Jet Machining (AWJM) is the non-traditional material removal process. It is an effective machining process for processing a variety of Hard and Brittle Material. And has various unique advantages over the other non-traditional cutting process like high machining versatility, minimum stresses on the work piece, high flexibility no thermal distortion, and small cutting forces .
