Transcription
NSF/ANSI 455-2 GOODMANUFACTURINGPRACTICES FORDIETARY SUPPLEMENTSINFORMATION GUIDE
NSF/ANSI 455-2 GOOD MANUFACTURINGPRACTICES FOR DIETARY SUPPLEMENTSINFORMATION GUIDETable of Contents1.What You Need to Know . 32.Certification Overview and Benefits. 43.Certification Documents . 54.Certification Process . 85.Audit Process . 96.Comparison of NSF/ANSI 455-2 GMP Standard and Audit Template . 137.Top 25 Commonly Cited Dietary Supplements FDA Inspection Observations . 158.What should you do? NSF/ANSI 455-2 GMP standard is here! . 189.NSF has the tools . 1910. Implementation Timeline for NSF/ANSI 455-2 GMP standard . 2011. Annex 1: Detailed Comparison of NSF/ANSI 455-2 GMP Standard and Audit Template . 212
On behalf of the NSF’s dietary supplements program, we thank you for choosing NSF as your GMPcertification service provider. By working with NSF, you are demonstrating your pledge to producequality products. NSF is a public health and safety organization, committed to protecting public healthand mitigating risk for our clients and consumers. This commitment means that we must continuouslyimprove our program and incorporate the latest regulations, guidance and industry best practices.Below are reading materials that will help you prepare for the new standard NSF/ANSI 455-2 GoodManufacturing Practices for Dietary Supplements.21 CFR Part 11 Electronic Records; /scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart 1121 CFR Part 111 Current GoodManufacturing Practice in Manufacturing,Packaging, Labeling, or Holding Operationsfor Dietary cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart 11121 CFR Part 117 Current GoodManufacturing Practice, Hazard Analysis,and Risk-Based Preventive Controls forHuman docs/cfcfr/CFRSearch.cfm?CFRPart 117Food Safety Modernization Act tion-act-fsmaPreventive Controls for Human uman-foodForeign Supplier Verification Programs animalsSanitary Transportation of Human and Animal on-humanand-animal-foodStandardized Information on Dietary Ingredients I 455-2 Good Manufacturing Practices forDietary Supplements*NSF/ANSI 455-2 Good Manufacturing Practices forDietary Supplements Audit Requirements Guideline*NSF International Certification Policies – NSF/ANSI 455**Note: Available in NSF Connect3 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
2. Certification Overview and BenefitsOverviewGood Manufacturing Practices (GMPs) are guidelines that provide a system of processes, procedures anddocumentation to assure a product has the identity, strength, composition, quality and purity that appearon its label. These GMP requirements are listed in NSF/ANSI 455-2 GMP standard which was developedby the dietary supplement industry in accordance with 21 CFR Part 11, 21 CFR Part 111 and Food SafetyModernization Act (FSMA).NSF International independently certifies manufacturers as meeting GMP requirements. The programis open not just to manufacturers of dietary supplements, but also to manufacturers of ingredients,raw materials, components, and packaging and labeling companies who want to demonstrate theircommitment to public safety.Benefits4 Provides risk-based audits to 21 CFR Part 111 and FSMA (21 CFR Part 117; 21 CFR Part 1.5;21 CFR Part 1.9) Prepares a facility for FDA inspections Allows a facility to benchmark its quality systems Helps facilities to build a strong quality and GMP program Creates eligibility to enter products into NSF’s product certification program Serves as a communication tool between manufacturers of dietary supplements, regulators,retailers, and consumers ANSI logo on certificates for global acceptance 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
3. Certification Documents1. NSF/ANSI 455-2 Good Manufacturing Practices for Dietary SupplementsThe standard is developed by the joint committee on GMP for dietary supplements using the consensusprocess described by American National Standards Institute. Participation includes dietary supplementsmanufacturers, public health regulators, consumers and retailers of dietary supplements.The standard is intended to define a standardized approach for auditing to determine the level ofcompliance of dietary supplement products to 21 CFR Part 111, Current Good Manufacturing Practices(GMPs) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well asincorporating additional industry requirements and FSMA.The standard has the following format and organization. “Shall” is used to state mandatory requirements. Document is written as follows:Section (#) – Area of focusSub-Section (#.#) – ISO quality management principleRequirement (#.#.#) – Standard requirementExample:4 Audit requirements4.1 Context of the organization4.1.1 Quality responsibilities shall be distinct and separate from operations. [21 CFR § 111.12(b)] 5The criteria in this standard was structured to be in the ISO 9001:2015 format, following a 7systems approach. Content of Organization Operation Leadership Performance Evaluation Planning Improvement Support 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
3. Certification Documents(cont’d)2. NSF/ANSI 455-2 Good Manufacturing Practices for Dietary Supplements Audit TemplateThe audit template is a tool used by auditors to assist in their on-site verification activity for complianceto the standard.To facilitate audit flow, the format of the audit template is rearranged in different sections comparedto the sections in the NSF/ANSI 455-2 GMP standard. See graphical representation below comparingthe two. Refer to section Comparison of NSF/ANSI 455-2 GMP Standard and Audit Template foradditional details.Administration& RegulatoryContext ityManagementWarehouse dardCAPA /ComplaintsAuditTemplatePlanningProduction& ProcessControlsOperationSupportNSF/ANSI 455-2 GMP StandardSupplierQualificationFacilitiesProduct SafetyAudit Template3. NSF/ANSI 455-2 Good Manufacturing Practices for Dietary Supplements Audit RequirementsGuideline (ARG)The document was developed to assist auditors and manufacturers to understand and interpret therequirements of the NSF/ANSI 455-2 GMP standard. The information in the guideline reflects the mostcurrent approach to achieving compliance with the standard requirements.6 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
3. Certification Documents(cont’d)4. NSF International Certification Policies – NSF/ANSI 455The document describes the framework for the administration of the program. The policies include, butare not limited to:7 Audit scope and process Requirements for acquiring and maintaining GMP certification Certification and monitoring audits Criteria for audit grade determination and audit frequency Requirements and timelines for corrective action responses Requirements for the correct use of NSF GMP certification marks 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
4. Certification ProcessAll clients shall go through a standardized audit process to gain certification. Below is an overview ofthe process.Self Assessment or3rd Party AssessmentApplication forCertification to CBAudit Planned & ExecutedAudit Report CompletedCB Management Review andcGMP Rating AssignedCorrective Action Plan(if applicable)Certification DecisionCertificate Issued(valid 12 months)Recertification AuditLegend:NSF ResponsibilityClient Responsibility8 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
5. Audit ProcessThis is the general flow of the audit process.1.Plan the AuditSchedule AuditPerform AuditTechnical Reviewof Audit ReportIssue of Auditand CAR ReportSubmit and Reviewof Corrective ActionClassification of NonconformancesThe auditor will cite a nonconformance when observations are made and evidence is collected duringthe audit that shows non-compliance with the standard requirement. Based on the auditor’s judgement,nonconformances are classified according to severity and risk to product safety. The severity ofnonconformances are then confirmed through a technical review prior to release of the audit report.The following are the three (3) levels of nonconformances1:19 Critical nonconformance – A nonconformance or condition which has produced, or may lead to asignificant risk of an unsafe or hazardous product which may be harmful and puts the consumerat risk of serious injury or death. Major nonconformance – A nonconformance other than critical that results in failure in one ormore of the quality subsystems; or a combination of “minor” nonconformances, none of whichon their own may be major, but which may together represent a major nonconformance and shallbe explained and reported as such. Minor nonconformance – A nonconformance where an element of GMP has not been fullymet or does not adversely affect the performance, reliability, or use of a product; but on thebasis of objective evidence does not meet the definition of a major nonconformance. Multipleminor nonconformances when considered collectively shall raise the category to a majornonconformance.NSF/ANSI 455-2-2018 – Good Manufacturing Practices for Dietary Supplements, section 5.5.9 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
5. Audit Process(cont’d)Where nonconformances are cited, corrective action must be submitted to NSF for review. Below is thegeneral flow of the corrective action after the audit.Approve CARIssue Audit andCAR Reports(10 days)*Submit CARs**to NSF Connect(10 days)Receive GMPCertificationReview CAR(5 days)Reject CARRework CAR(5 days)Legend:NSF ResponsibilityClient ResponsibilitySubmit CAR Rework* Days are calculated from the last day of the audit.** Overdue CARs shall result in suspension or denial of certification.10 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
5. Audit Process2.(cont’d)Audit GradeThe auditor submits a draft report for technical review after the audit. At the technical review, thenonconformances are confirmed and the audit grade is determined based on the number and severity ofnonconformances cited.Summary of Grading Model2GradeCriticalMajorMinorA00 7B01 7B008 to 15C01 15 (8 to 15*)C0016 to 22 (16 to 23*)D 1––D0 2–D01 18 ( 16*)D00 27 ( 24*)* Recommended changes by NSF submitted to NSF/ANSI 455-2 Joint Committee to remove the gaps and/or overlap of grades. NSF willfollow the recommended changes when determining audit grade.211NSF/ANSI 455-2-2018 – Good Manufacturing Practices for Dietary Supplements, Table 5.2 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
5. Audit Process(cont’d)3. Audit FrequencyThe frequency of audits is based on the audit grade. Below is the general audit cycle. Please refer toNSF/ANSI 455-2 GMP Section 5 for a more detailed explanation.Grades A & B** Grades A & B may require a monitoring audit for failure to closeoutrepeat nonconformance from the previous certification audit.Certification AuditGrade CGradeMonitoring Audit(6 months from initial)Certification Audit(12 months fromprevious Certification/Recertification Audit)DFailure12 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
6. Comparison of NSF/ANSI 455-2 GMP Standard and Audit TemplateTo facilitate audit flow, the format of the audit template is rearranged into sections different from theNSF/ANSI 455-2 GMP standard. The table below shows the distribution of NSF/ANSI 455-2 GMP standardrequirements in the audit template sections.AuditTemplateSectionsTitleNSF/ANSI 455-2 GMP Standard Requirement No.Section 0Visit Summary5.5.1, 5.5.3, 5.5.8Section 1Client Logistics1.1, 1.2, 1.3, 3.28Section AAdministration andRegulatory4.1.3Section BSection CCorrective andPreventive Actions &ComplaintsSection DSupplier QualificationSection ESection F13Quality ManagementProduct .4.40 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
6. Comparison of NSF/ANSI 455-2 GMP Standard and Audit TemplateAuditTemplateSectionsSection GSection H14TitleProduction andProcess Controls– Manufacturing,Packaging Operations& Product Specification,Release and ReturnsLaboratory Controls(cont’d)NSF/ANSI 455-2 GMP Standard Requirement 74.6.174.6.164.5.374.6.184.6.15Section IWarehouse andDistribution 4.5.74Section JNSF Certification PoliciesCompliance against NSF certification policies 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
7. Top 25 Dietary Supplements FDA Inspection ObservationsDuring a FDA inspection of a facility, the inspector may observe conditions or practices that may bedeemed to be in violation of FDA’s requirements. The graph and table below summarize the top 25observations in 2018 for dietary supplements against 21 CFR Part 111.For additional information, please refer rences/inspection-observations791312121221 CFR 111.40321 CFR 111.551821 CFR 111.25(c)2121 CFR 111.162321 CFR 111.570(b)(1)2321 CFR 111.70(d)2921 CFR 111.535(b)(1)3021 CFR 111.475(b)(1)3221 CFR 111.205(a)3221 CFR 111.653521 CFR 111.5033521 CFR 111.255(a)3621 CFR 111.205(a)3721 CFR 111.75(a)(2)(ii)(A)3721 CFR 111.83(a)4121 CFR 111.70(b)(2)4321 CFR 111.75(c)4321 CFR 111.70(b)(1)4521 CFR 111.55321 CFR 111.45321 CFR 111.75(a)(1)(i)4721 CFR 111.105(a)5421 CFR 111.255(b)5721 CFR 111.103908070605040302010021 CFR 111.70(e)Frequency of ObservationsTop 25 FDA Inspection Observations FY2018Dietary Supplement Regulation15 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
7. Top 25 Dietary Supplements FDA Inspection Observations16(cont’d)No.Reference NumberShort DescriptionLong Description121 CFR 111.70(e)Specifications – identity, purity,strength, compositionYou did not establish product specifications for the[identity] [purity] [strength] [composition] of thefinished dietary supplement.221 CFR 111.103Written procedures – qualitycontrol operationsYou did not [establish] [follow] written proceduresfor quality control operations.321 CFR 111.75(a)(1)(i)Component – verify identity,dietary ingredientYou did not conduct at least one appropriate testor examination to verify the identity of a dietaryingredient, prior to its use.421 CFR 111.453Written procedures – holdingYou did not [establish] [follow written] proceduresfor holding and distributing operations.521 CFR 111.255(b)Batch record – completeYour batch production record did not includecomplete information relating to the productionand control of each batch.621 CFR 111.553Written procedures – productcomplaintYou did not [establish] [follow] written proceduresfor the requirements to review and investigate aproduct complaint.721 CFR 111.70(b)(1)Specifications – componentidentityYou did not establish an identity specification foreach component.821 CFR 111.75(c)Specifications met – verify;finished batchYou did not verify that your finished batch ofdietary supplement meets product specificationsfor [identity] [purity] [strength] [composition] [limitson contamination that may adulterate or that maylead to adulteration of the dietary supplement].921 CFR 111.70(b)(2)Specifications-componentpurity, strength, compositionYou did not establish component specifications for[purity] [strength] [composition].1021 CFR 111.83(a)Reserve sample – collect, holdYou did not collect and hold reserve samples ofpackaged and labeled dietary supplements thatyou distributed.1121 CFR 111.75(a)(2)(ii)(A)Component – qualify supplierYou did not qualify a supplier of a componentby establishing the reliability of the supplier'scertificate of analysis through confirmation of theresults of their tests or examinations.1221 CFR 111.205(a)Master manufacturing record –each batchYou did not [prepare] [follow] a written mastermanufacturing record for each batch size of adietary supplement that you manufactured.1321 CFR 111.255(a)Batch record – every batchYou did not prepare a batch production recordevery time you manufactured a batch of dietarysupplement.1421 CFR 111.503Written procedures – returneddietary supplementYou did not [establish] [follow] written proceduresfor when a returned dietary supplement isreceived. 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
7. Top 25 Dietary Supplements FDA Inspection ObservationsNo.Reference NumberShort DescriptionLong Description1521 CFR 111.65Quality control – quality, dietarysupplementYou did not implement quality control operationsto ensure the quality of the dietary supplement.1621 CFR 111.205(a)Master manufacturing record –unique formulationYou did not [prepare] [follow] a written mastermanufacturing record for each unique formulationof a dietary supplement that you manufactured.1721 CFR 111.475(b)(1)Written procedures – holding;distributingYou did not make and keep written procedures forholding and distributing operations.1821 CFR 111.535(b)(1)Records – returned dietarysupplement: written proceduresYou did not make and keep records of writtenprocedures for fulfilling requirements for returneddietary supplements.1921 CFR 111.70(d)Specifications – labels,packagingYou did not establish [label] [packaging]specifications.2021 CFR 111.570(b)(1)Written procedures – productcomplaint; review, investigateYou did not make and keep written proceduresto fulfill the requirements that apply to the reviewand investigation of a product complaint.2121 CFR 111.16Written procedures – cleaningYou did not [establish] [follow] written proceduresfor cleaning the physical plant.Processes, specifications,written proceduresYour quality control personnel did not approveor reject [processes] [specifications] [writtenprocedures] [controls] [tests] [examinations][deviations or modifications] that may affect theidentity, purity, strength, or composition of adietary supplement.2221 CFR 111.105(a)2321 CFR 111.25(c)Procedures – equipment –cleaning, sanitizingYou did not [establish] [follow] written proceduresfor maintaining, cleaning, and sanitizing,equipment, utensils, and any other contactsurfaces that are used to manufacture, package,label, or hold components or dietary supplements.2421 CFR 111.403Written procedures – labelingoperationsYou did not [establish] [follow] written proceduresfor labeling operations.Production, process controls –implementYou did not implement a system of productionand process controls that covers all stages ofmanufacturing, packaging, labeling, and holdingof dietary supplements to ensure the quality of thedietary supplement.2517(cont’d)21 CFR 111.55 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
WHAT SHOULD YOU DO?NSF/ANSI 455-2 GMP STANDARD IS HERE!Become informed Review the NSF materials and tools NSF/ANSI 455 GMP Policies Audit Template NSF/ANSI 455-2 GMP Standard Training Videos NSF/ANSI 455-2 GMP ARGReview regulations applicable to Dietary Supplements 21 CFR Part 11; Part 111; Part 117 Food Safety Modernization Act (FSMA), Foreign Supplier VerificationPrograms (FSVP) for Importers of Food for Humans & Animals Sanitary Transportation of Human and Animal FoodPlan your application for certification Review and confirm the scope applicable to your operations Communicate the standard requirements to your organization Perform a self-assessment and gap analysis of your current operations againstthe standard Contact NSF if you have questionsSubmit application for certification to NSF Prepare the documents as required by the standard and by NSF include, butare not limited to: Company organizational chart Site plan 18 Standard operating proceduresindex/table of contentsProcess flow diagram List of products andtechnologies included in thescope of the auditRegulatory inspection history(past five years) Site regulatory registration Submit completed and signeddocuments to NSFTypical shift/schedule patternsContact NSF if you have questions 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
NSF HAS THE TOOLSWhether you are currently registered or are looking to newly register, we have the tools to help youprepare for your next certification audit.19Audit TemplateTop FDA InspectionObservationsNSF/ANSI 455Certification PoliciesNSF/ANSI 455-2 GMP Standardfor Dietary SupplementsWebinarInformation &Transition GuideNSF/ANSI 455-2 GMPARG for Dietary SupplementsRegulatoryResource LinksFAQs 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
10. Implementation Timeline for NSF/ANSI 455-2 GMP StandardStarting November 2019 NSF is offering certification to NSF/ANSI 455-2 GMP standard. Please contactyour account manager to start the certification process for your company.20 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
Annex 1: Detailed Comparison ofNSF/ANSI 455-2 GMP Standard & Audit TemplateNSF/ANSI455-2GMP AuditTemplateQuestionNumberNSF/ANSI 455-2 GMP AuditTemplate SectionNSF/ANSI455-2 GMPStandardRequirementNumberNSF/ANSI 455-2 GMP StandardSection1–7Visit Summary and Client LogisticsNANA8Administration and Regulatory4.1.3Context of the organization9Quality Management4.2.9Leadership10Quality Management4.2.10Leadership11Quality Management4.2.8Leadership12Quality Management4.2.11Leadership13Quality Management4.2.2Leadership14Quality Management4.2.12Leadership15Quality Management4.2.1Leadership16Quality Management4.1.2Context of the organization17Quality Management4.1.1Context of the organization18Quality Management4.2.5Leadership19Quality Management4.4.33Support20Quality Management4.4.32Support21Quality Management4.2.6Leadership22Quality Management4.2.7Leadership23Quality Management4.4.35Support24Quality Management4.4.35Support25Quality Management4.4.34Support26Quality Management4.4.36Support27Quality Management4.4.37Support28Quality Management4.4.41Support29Quality Management4.4.43Support30Quality Management4.4.45Support31Quality Management4.4.46Support32Quality Management4.4.38Support33Quality Management4.4.44Support21 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
NSF/ANSI455-2GMP AuditTemplateQuestionNumberNSF/ANSI 455-2 GMP AuditTemplate SectionNSF/ANSI455-2 GMPStandardRequirementNumberNSF/ANSI 455-2 GMP StandardSection34Quality Management4.4.42Support35Quality Management4.3.6Planning36Quality Management4.6.25Performance evaluation37Quality Management4.6.26Performance evaluation38Corrective and Preventive Actions and Complaints4.7.3Improvement39Corrective and Preventive Actions and Complaints4.6.19Performance evaluation40Corrective and Preventive Actions and Complaints4.6.20Performance evaluation41Corrective and Preventive Actions and Complaints4.6.21Performance evaluation42Corrective and Preventive Actions and Complaints4.6.22Performance evaluation43Corrective and Preventive Actions and Complaints4.6.23Performance evaluation44Corrective and Preventive Actions and Complaints4.6.24Performance evaluation45Corrective and Preventive Actions and Complaints4.6.28Performance evaluation46Supplier Qualification4.5.24Operation47Supplier Qualification4.3.2Planning48Supplier Qualification4.5.28Operation49Supplier Qualification4.5.25Operation50Supplier Qualification4.5.26Operation51Supplier Qualification4.6.8Performance evaluation52Supplier Qualification4.6.9Performance evaluation53Supplier Qualification4.5.34Operation54Supplier Qualification4.5.36Operation55Supplier Qualification4.5.27Operation56Supplier Qualification4.5.33Operation57Supplier Qualification4.5.35Operation58Supplier Qualification4.4.40Support59Product Safety4.3.1Planning60Product Safety4.5.46Operation61Product Safety4.5.13Operation62Product Safety4.5.14Operation63Product Safety4.5.17Operation64Product Safety4.5.18Operation22 2019 NSF International – Unless otherwise specified, no part of this document may be reproduced or utilized in any form byany other means, electronic or mechanical, including photocopying and microfilm, without permission of NSF International.
NSF/ANSI455-2GMP AuditTemplateQuestionNumberNSF/ANSI 455-2 GMP AuditTemplate SectionNSF/ANSI455-2 GMPStandardRequirementNumberNSF/ANSI 455-2 GMP StandardSection65Product Safety4.5.16Operation66Product Safety4.5.21Operation67Product Safety4.5.15Operation68Product Safety4.5.23O
Provides risk-based audits to 21 CFR Part 111 and FSMA (21 CFR Part 117; 21 CFR Part 1.5; 21 CFR Part 1.9) Prepares a facility for FDA inspections Allows a facility to benchmark its quality systems Helps facilities to build a strong quality and GMP program Creates eligibility to enter products into NSF's product certification program
