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NSF/ANSI 455-2 GOODMANUFACTURING PRACTICESFOR DIETARY SUPPLEMENTS ANDDIETARY INGREDIENTSTRANSITION GUIDE1 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
NSF/ANSI 455-2 GOOD MANUFACTURINGPRACTICES FOR DIETARY SUPPLEMENTS ANDDIETARY INGREDIENTS TRANSITION GUIDETable of Contents21.Overview of NSF/ANSI 455-2 GMP Certification. 32.NSF/ANSI 455-2 GMP Certification vs. NSF GMP Registration Programs. 53.Transition Process. 104.Annex: Comparison of NSF/ANSI 455-2 GMP Certification and NSF GMP Registration Audit Templates. 11
1. Overview of NSF/ANSI 455-2 GMP CertificationIn January 2019, the Global Retailer and Manufacturer Alliance (GRMA) announced the publication of NSF/ANSI 455 standards, a set of consensus-based GoodManufacturing Practices (GMP) requirements for manufacturers of dietary supplements (NSF/ANSI 455-2), cosmetics and personal care products (NSF/ANSI 455-3)and over-the-counter drugs (NSF/ANSI 455-4). In addition, an Audit Requirements Guideline (ARG) were published as companion documents to assist with theinterpretation of each standard. A fourth standard, NSF/ANSI 455-1 Terminology for the NSF 455 Portfolio of Standards, was also published as a supplement tothe three (3) NSF/ANSI 455 GMP standards.The NSF/ANSI 455-2 GMP for Dietary Supplement standard was developed in accordance with 21 CFR Part 11, 21 CFR Part 111, and applicable Food SafetyModernization Act (FSMA) final rules: Preventive Controls for Human Food (21 CFR Part 117), Sanitary Transportation of Human and Animal Food, and ForeignSupplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. The purpose of NSF/ANSI 455-2 is to address key challenges in the dietarysupplements industry by having one accepted standard.Key Industry ChallengeInconsistencybetweenaudits andauditorsUnable toreview auditresultsRetailerGMP auditsnot mitigatingsupplierrisks3Audit fatigueManufacturerInterpretationof GMPrequirements& guidanceDifferentretailerrequirements 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
1. Overview of NSF/ANSI 455-2 GMP Certification (cont’d)Benefits of transitioning to NSF/ANSI 455-2 GMP Certification Public standard developed in consensus by manufacturers, retailers, public health regulators, and certification bodies American National Standards Institute (ANSI) accredited standard One industry GMP standard Mitigate supplier risk Calibration of certification bodies and auditors to one standard Standardized audit report ANSI logo on certificates for global recognition Prevent manufacturers’ audit fatigue by reducing the number of audits in a year Reduce associated costs of auditing to multiple independent standards Assists manufacturers with continuous improvement Assists manufacturers with implementing industry best practices Greater consumer confidence in manufacturers and their products Accepted by retailersOut of ScopeWarehouse and distribution centers (standalone), brokers, label designers, laboratories, office buildings, transport companies,E-Commerce, or facilities producing medical food or functional food do not qualify for certification to NSF/ANSI 455.4 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
2. NSF ANSI 455-2 GMP Certification vs. NSF GMP Registration ProgramsThe NSF/ANSI 455-2 GMP Certification and NSF GMP Registration are both developed in accordance with 21 CFR Part 1.9, 21 CFR Part 11, 21 CFR Part 111 andFSMA regulations.Key Differences Pre-Audit documentationA company seeking certification to NSF/ANSI 455-2 GMP Certification must provide documents to NSF at minimum of one (1) business week prior to thescheduled audit date.Documents required include but are not limited to:5 Company organizational chart Site plan Process flow diagram List of products and technologies included in the scope of the audit Typical shift/schedule patterns Standard operating procedures index/table of contents Regulatory inspection history (past five years) Site regulatory registration 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
2. NSF ANSI 455-2 GMP Certification vs. NSF GMP Registration Programs (cont’d) Document formatThe NSF/ANSI 455-2 GMP standard document structure is based on an ISO 9001 format while the NSF GMP Registration Requirements document structure isbased on a Quality Management Systems format.NSF/ANSI 455-2 GMP StandardNSF GMP Registration RequirementsContext ofOrganizationElectronicRecords &SignaturesImprovementAdministration& RegulatoryQualityManagementLeadershipWarehouse andDistributionGMPRegistrationNSF/ANSI ion &Process ControlsFood SafetyFacilities6 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
2. NSF ANSI 455-2 GMP Certification vs. NSF GMP Registration Programs (cont’d) Audit Grade RuleAudit grade calculation is based on the number and severity of the nonconformances defined by the standard. The result obtained in your NSF/ANSI 455-2GMP audit may differ from your NSF GMP Registration audit.NSF/ANSI 455-2 GMP CertificationGrade RuleNSF GMP RegistrationGrade A00 7A009 or fewer01 70010 to 17008 to 15019 or fewer01 15 (8 to 15*)0018 to 26110 to 17016 to 22(16 to 23*)00029 or fewer 1––0027 or more0 2–0118 or more01 18 ( 16*)0210 or more00 27 ( 24*)03 or more0 or more1 or more0 or more0 or moreBCDBCFail*R ecommended changes by NSF submitted to NSF/ANSI 455-2 Joint Committee to remove thegaps and/or overlap of grades. NSF will follow the recommended changes when determiningaudit grade.7 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
2. NSF ANSI 455-2 GMP Certification vs. NSF GMP Registration Programs (cont’d) Post-Audit deadlinesNSF/ANSI 455-2 GMP Certification and NSF GMP Registration have similar post audit processes, however NSF/ANSI 455-2 GMP has a shorter corrective actionreview timeframe, as shown in the process flow below.NSF/ANSI 455-2 GMP CertificationApprove CARReceive GMPCertificationGrade IssuancePerform AuditConduct ReportTechnical ReviewIssue Audit and CAR Reports– (10 days)*Submit CARs** to NSFConnect – (10 days)Legend:Review CAR(5 days)Reject CARNSF ResponsibilityRework CAR(5 days)Client ResponsibilitySubmit CAR ReworkNSF Connect* Days are calculated from the last day of the audit.** Overdue CARs shall result in suspension or denial of certification.NSF GMP RegistrationApprove CARReceive GMPRegistrationGrade IssuancePerform AuditConduct ReportTechnical ReviewIssue Audit and CAR Reports– (5 days)*Legend:NSF ResponsibilitySubmit CARs** to NSFConnect – (30 days)Review CARReject CARRework CARClient Responsibility* Days are calculated from the last day of the audit.** Overdue CARs may result in suspension or denial of certification.8Submit CAR ReworkNSF Connect 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
2. NSF ANSI 455-2 GMP Certification vs. NSF GMP Registration Programs (cont’d) Repeat NonconformancesNonconformances cited during a previous audit that are not corrected by the next scheduled audit shall be assessed as Repeat nonconformances.Nonconformance cited are based on risk in accordance to the definition in the standard of Critical, Major and Minor.NSF/ANSI 455-2 GMP Certification9 A repeat Minor nonconformance is elevated to a Majornonconformance if not closed out within three (3) monthsof the certification audit. An amended report is issued with the revisednonconformance classification. This may impact theaudit grade. Failure to provide objective evidence within the three (3)month period may result in Suspension. Monitoring audit is conducted within six (6) months of thecertification audit.NSF GMP Registration A repeat Minor nonconformance is not elevated to aMajor nonconformance. Failure to close out repeat nonconformances may result toa suspension. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
3. Transition Process What should I do to start the transition process?1. Review all the applicable NSF/ANSI 455-2 GMP tools. NSF/ANSI 455 GMP Certification Policies NSF/ANSI 455-2 GMP Standard NSF/ANSI 455-2 GMP ARG Audit Template Training Videos Transition Guide2. Conduct a pre-assessment to the NSF/ANSI 455-2 Standard utilizing the Transition Document Annex, NSF/ANSI 455-2 GMP Standardand Auditor Requirements Guideline. This is a requirement by the Standard. The pre-assessment may be conducted by a third-party orby your organization. Identify gaps / nonconformances found during the pre-assessment. Apply and implement pre-assessment corrective actions. Verify and ensure corrective actions are implemented and effective.3. Close out nonconformances from your previous NSF GMP Registration audit and implement corrective actions.4. Submit application documents to NSF. When can I transition from a NSF GMP Registration audit to NSF/ANSI 455-2 GMP Certification audit? When you have determined you are ready for the NSF/ANSI 455-2 certification audit, contact yourNSF Account Manager who will assist you with the next steps.10 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
Annex: Comparison of NSF/ANSI 455-2 GMP Certification andNSF GMP Registration Audit TemplatesThis table provides comparison of NSF/ANSI 455-2 GMP Certification to NSF GMP Registration audit templates.NSF GMP Registration Requirements Document may be more detailed in some sections than NSF/ANSI 455-2 GMP Certification. In the following table, where the“Differences” column mentions “Comparable requirements,” the intention is the same. The requirements will be enforced in a same manner for both programs.This table is applicable for both dietary supplements and dietary ingredients.8Administrationand Regulatory911QualityManagementNA4.1.3 US FDA facility and Bioterrorismregistrations and process filingsshall be current and maintained.(physical address, scope,expiration dates, etc.)NSF/AStan NSI 45dard 5-2SectionNAVisit summaryand clientlogisticsNAContextof theorganizationAdministrationand RegulatoryA.1.3Facility shall be registered with theUS Food & Drug Administration(USFDA).A.1.4Procedures to register all requiredprocesses and products with theUSFDA shall be documented,implemented and maintained.A.3.1There shall be procedures forpersonal hygienic practices.Procedures include but are notlimited to donning appropriategarments, and exercising personalhygiene (i.e.; hand washing,sanitization, etc.) prior to startingwork, returning from break(restroom or otherwise) andfollowing any event wherebypersonnel may become soiled orcontaminated.4.2.9 Hygienic practices shall beLeadershipestablished to include appropriategarments, personal hygiene,hand washing, and sanitization,etc. prior to starting work and atany time whereby personnel canbecome soiled or tionand RegulatoryQuestionQuestionClient informationDifferencesRequirement#Visit summaryand clientlogisticsNSF GMP RegistrationAuditSect Templaionte1-7Standard#AuditSect TemplaionteAudQue it Tempstion late#NSF/ANSI 455-2 GMP CertificationClient information.Comparable requirements.Comparable requirements.Comparable requirements. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
NSF GMP RegistrationAdministrationand RegulatoryA.3.1There shall be procedures forpersonal hygienic practices.Procedures include but are notlimited to donning appropriategarments, and exercising personalhygiene (i.e.; hand washing,sanitization, etc.) prior to startingwork, returning from break(restroom or otherwise) andfollowing any event wherebypersonnel may become soiled orcontaminated.A.3.2The facility GMP Program shallinclude protections againstcontamination, including but notlimited to: smokeless tobacco orchewing tobacco; cigarettes ore-cigarettes, food, beverages,outside bags/clothing, personalitems, etc.A.3.312QuestionRequirement#4.2.10 Procedures shall be in placeLeadershipfor use of impermeable gloves,hairnets, caps, beard covers,etc. and for restrictions on theuse of food, drinks, tobacco,etc. in areas whereby productcontamination could occur.Procedures shall be established toprevent contamination from allpotential sources. ct TemplaionteNSF/AStan NSI 45dard 5-2SectionQualityManagementQuestionAuditSect Templaionte10Standard#AudQue it Tempstion late#NSF/ANSI 455-2 GMP CertificationComparable requirements.A written dress code including shoepolicy shall exist stating appropriateattire for workers (includingtemporary), supervisors, managers,contractors, vendors and visitors toall parts of the GMP areas includingbut not limited to production,storage, packaging and testingfacilities. Dress code shall includeuse of captive uniforms, shoesand use of disposable outergarments, where applicable. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
121313QualityManagementQualityManagement4.2.11 Procedures shall be in placefor the control of jewelry andother personal care items.[21CFR111.10(b4)]4.2.2 Management shall conductbiennial reviews to assess thesuitability and effectiveness ofthe quality system.LeadershipLeadershipAdministrationand RegulatoryA.3.1Administrationand irement#4.2.8 Procedures shall be establishedLeadershipthat define work requirements forpersonnel to prevent microbialcontamination due to a healthcondition. [21CFR111.10(a)]AuditSect TemplaionteNSF GMP RegistrationNSF/AStan NSI 45dard 5-2SectionQualityManagementQuestionAuditSect Templaionte11Standard#AudQue it Tempstion late#NSF/ANSI 455-2 GMP CertificationThere shall be procedures forpersonal hygienic practices.Procedures shall include but arenot limited to donning appropriategarments, and exercising personalhygiene (e.g.; hand washing,sanitization, etc.) prior to startingwork, returning from break(restroom or otherwise) andfollowing any event wherebypersonnel may become soiled orcontaminated.Comparable requirements.There shall be procedures forpersonal hygienic practices.Procedures shall include but arenot limited to donning appropriategarments, and exercising personalhygiene (e.g.; hand washing,sanitization, etc.) prior to startingwork, returning from break(restroom or otherwise) andfollowing any event wherebypersonnel may become soiled orcontaminated.Comparable requirements.B.1.1Management is responsible forQuality Management.Comparable requirements.B.1.2Senior management shall have aprocess for reviewing the QualitySystem and performance indicatorson at least an annual basis.A.3.1 455-2: 4.2.2 defines biennial reviews bymanagement. NSF GMP: B.1.2 defines annual reviewby senior management. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
4.2.1 Procedures shall be establishedfor the responsibilities of the QCoperations. [21CFR111.103 and21CFR111.105]LeadershipAdministrationand RegulatoryA.2.1There shall be Standard OperatingProcedure (SOP) and records ofregulatory visit, inspections, or both.Comparable requirements.Administrationand RegulatoryA.2.2SOPs for regulatory visit orinspection shall include provisionsfor reporting regulatory citationsto impacted customers and NSFInternational.Comparable requirements.QualityManagementB.1.4There shall be a visitor procedureapplicable to all non-site employees.Comparable requirements.QualityManagementB.2.3Quality Personnel shall haveestablished roles and responsibilities.Comparable requirements.LaboratoryControlsH.1.9Procedures for managinganalytical, microbiological andphysical instrument calibrationand maintenance results shall tLeadershipDifferencesAuditSect Templaionte154.2.12 Visitor (regulator, contractor,customer, non-site employee,etc.) policy and procedures shallbe established.NSF GMP RegistrationNSF/AStan NSI 45dard 5-2SectionQualityManagementQuestionAuditSect Templaionte14Standard#AudQue it Tempstion late#NSF/ANSI 455-2 GMP Certification16QualityManagement4.1.2 Quality control (QC) operationsshall be identified andimplemented. [21CFR111.65]Contextof theorganizationQualityManagementB.2.3Quality Personnel shall haveestablished roles and responsibilities.17QualityManagement4.1.1 Quality responsibilities shallbe distinct and separate fromoperations. [21CFR111.12(b)]Contextof theorganizationQualityManagementB.1.3Quality shall not report directly toOperations, or other areas functionsthat pose a conflict of interest; toensure that quality decision makingremains distinct and independent.QualityManagement4.2.5 QC operations and responsibilities Leadershipshall include the authority toreject any component or productif any specification is not Management4.4.33 Procedures shall be established to Supportdetermine the requirements andqualifications (such as education,training, or experience) forpersonnel who will superviseactivities. [21CFR111.13(a), (b) &21CFR 117.4]QualityManagementB.2.4181914Quality Personnel shall haveestablished roles and responsibilities. 455-2 does not define a timeframe toreport OOS results. NSF GMP: H.1.9 defines OOS resultsshall be sent to the facility based on anagreed timeframe, which shall not exceedone (1) business day from the resultconfirmation.Comparable requirements.Comparable requirements.Comparable requirements.There shall be defined supervisortraining and responsibilities.Comparable requirements. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
21QualityManagement4.4.32 Personnel shall be qualifiedand have adequate training,experience and/or educationnecessary to perform jobfunctions. [21CFR111.12(c) &21CFR 117.4]LeadershipLeadershipQualityManagement4.2.6 Sanitation supervisors shall beassigned and shall be tyManagement15Support4.4.31 Controls shall be in place toverify the backgrounds ofnew, contracted, seasonal andtemporary employees prior tohiring. Temporary employeesprior to onRequirement#AuditSect TemplaionteNSF GMP RegistrationNSF/AStan NSI 45dard 5-2SectionQualityManagementQuestionAuditSect Templaionte20Standard#AudQue it Tempstion late#NSF/ANSI 455-2 GMP CertificationPersonnel shall have the appropriatequalifications; and have adequatetraining, experience, and educationnecessary to perform identified jobfunctions.Comparable requirements.QualityManagementB.2.8There shall be an assessment oflearning following training todocument effectiveness.Comparable requirements.QualityManagementB.2.1Background check procedures shallbe defined and implemented for allpersonnel, including but not limitedto contracted, temporary, seasonalpersonnel as part of the new hiringprocess. Criminal backgroundchecks are not required.Comparable requirements.QualityManagementB.2.5Qualified sanitation supervisors shallbe assigned.4.2.7 Competent supervisory personnel Supportshall be responsible for ensuringtransportation operations areconducted in compliance with21CFR 1.908. [21CFR1.908]QualityManagementB.2.4Supervisor training andresponsibilities shall be defined.4.4.35 Job descriptions shall be available Supportfor all personnel and personnelhave received food safety,GMP, and appropriate trainingfor their assigned functions.[21CFR111.12(a) & 21CFR117.4]QualityManagementB.2.2Personnel shall have the appropriatequalifications; and have adequatetraining, experience, and educationnecessary to perform identified jobfunctions.B.2.6All personnel including temporarystaff and contractors shall betrained in appropriate policies andprocedures.B.2.7Refresher training shall beconducted at least annually.Comparable requirements.Comparable requirements.Comparable requirements. 455-2: 4.4.35 does not define thefrequency of refresher training. NSF GMP: B.2.7 defines the frequency asannually. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
2627282916QualityManagement4.4.34 Records shall be maintaineddocumenting complianceto established proceduresthat ensure that supervisorsare appropriately qualifiedby education, training, orexperience. [21CFR111.14(a), (b)& 21CFR tionRequirement#AuditSect TemplaionteNSF GMP RegistrationNSF/AStan NSI 45dard 5-2SectionQualityManagementQuestionAuditSect Templaionte25Standard#AudQue it Tempstion late#NSF/ANSI 455-2 GMP CertificationTraining records shall be maintained.Comparable requirements.4.4.36 A document control programSupportshall be established andfollowed outlining the initiation,formatting, review, approval,distribution (to include personneltraining requirements),document storage, changecontrol, retention, and disposalof documents and records.[21CFR111.105]QualityManagementB.6.1A document management programshall be established.B.6.2Most recent revisions of documentsshall be accessible to appropriatepersonnel and positions.B.6.3Review of documents shall occur on 455-2: 4.4.36 does not define thea defined frequency, at least oncefrequency of document review.every three years, unless otherwise NSF GMP: B.6.3 defines the frequency asjustified.at least once every three years.QualityManagement4.4.37 Good documentation practicesSupportshall be established and followedconcerning paper and electronicdocuments and records.[21CFR111.105]QualityManagementB.6.4Good Documentation Practices(GDP) shall be established andimplemented.Comparable requirements.QualityManagement4.4.41 Procedures shall be establishedthat describe the requirementsfor record retention underSubpart P – Records andRecordkeeping. [21CFR111.605]SupportQualityManagementB.6.7Records retention policy shallbe defined, documented andimplemented.Comparable requirements.QualityManagement4.4.43 All records shall be maintainedas original record, as truecopies or as electronic .6.8Quality records shall be maintainedand available for review.Comparable requirements.Comparable requirements. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
anagement4.4.45 Electronic GMP inventory records Supportthat are created, modified,maintained, archived, retrieved,or distributed by a computersystem, shall be 21CFR11compliant. [21CFR11]DifferencesQuestionRequirement#AuditSect TemplaionteNSF GMP RegistrationNSF/AStan NSI 45dard 5-2SectionQualityManagementQuestionAuditSect Templaionte30Standard#AudQue it Tempstion late#NSF/ANSI 455-2 GMP CertificationQualityManagementB.6.5Electronic forms shall be includedin the document managementprogram, and shall be compliantwith 21 CFR Part 11, and §B.6.1.ElectronicRecords &SignaturesJ.1.1Electronic signatures andhandwritten signatures associatedwith electronic records shallbe linked to their respectiveelectronic records to ensure thatthe signatures cannot be excised,copied, or otherwise transferredto falsify an electronic record byordinary means.4.4.46 Backup electronic files shall beSupportmaintained of the following;current software programs,outdated software programsthat may be necessary to retrievepast records, and data that wasentered. Backup files shall bean exact and complete recordand are secure from alterations,erasures, or loss and damage.[21CFR111.35(b5i), (b5ii)]ElectronicRecords &SignaturesJ.1.2Each electronic signature shall beunique to one individual. It shallnot be reused by or reassigned toanyone else.J.1.3Electronic signatures shall beprotected to ensure that they areonly used by their genuine owners.4.4.38 QC operations shall prepare and Supportmaintain all records requiredby Subpart F – Productionand Process Control System:Requirements for Quality Control.[21CFR111.140]QualityManagementB.6.6Record management shall bedocumented and implemented.4.4.44 QC operations shall maintainappropriate records as parable requirements.Comparable requirements.Comparable requirements.B.6.6Record management shall bedocumented and implemented.Comparable requirements. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
353618QualityManagementQualityManagement4.4.42 Records required by 21 CFR 111shall be maintained for at leastone year after the shelf life dateor at least two years beyondthe date of distribution of thelast batch associated with thoserecords. [21CFR111.605(a)]Support4.3.6 A crisis management plan isdeveloped to manage significantdisruptive events, including, butnot limited to, natural disastersand catastrophic events thatmay impact the ability of themanufacturer to deliver a safeproduct.Planning4.6.25 Procedures shall be establishedPerformanceto define the recall of a product. evaluationThe written recall plan shallinclude procedures that describethe steps to be taken, and assignresponsibility for taking thosesteps as appropriate to thefacility. ement#AuditSect TemplaionteNSF GMP RegistrationNSF/AStan NSI 45dard 5-2SectionQualityManagementQuestionAuditSect Templaionte34Standard#AudQue it Tempstion late#NSF/ANSI 455-2 GMP CertificationQuarantine records shall bemaintained for one (1) year beyondthe shelf life of the product, ortwo (2) years beyond the date ofdistribution of last nonconformingbatch, whichever is greater.Crisis Management (Back-UpPlan or Disaster Recovery Plan)procedures shall be developed toaddress any critical situations thatmay occur, such as natural disastersand catastrophic events any andother emergency situations. (e.g.power outage, fires, InformationTechnology (IT), tampering, waterinterruption, etc.)B.3.2Provisions shall be in place forpower backup sources to criticalsystems in the event of main powerfailure. Written procedures forrecovery from power failure shallexist.B.5.4Recall and withdrawal procedureshall be established andimplemented.B.5.6Records of product withdrawals andrecalls, mock recall exercises shall bemaintained.Comparable requirements.Comparable requirements.Comparable requirements. 2020 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form by any other means, electronic or mechanical, including photocopying andmicrofilm, without permission of NSF International.
383919Corrective andPreventiveActions andComplaintsCorrective andPreventiveActions andComplaints4.6.26 Procedures shall be establishedto define traceability and mockrecall exercises at a minimumof once a year to include traceforward and trace .
The NSF/ANSI 455-2 GMP for Dietary Supplement standard was developed in accordance with 21 CFR Part 11, 21 CFR Part 111, and applicable Food Safety Modernization Act (FSMA) final rules: Preventive Controls for Human Food (21 CFR Part 117), Sanitary Transportation of Human and Animal Food, and Foreign
