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Intro to cGMPs:The Building Blocks for
GFSI ComplianceSonia AkbarzadehFounder & Partner
Food Industry Consulting, Inc.
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Rajan GuptaVP Customer SuccessTraceGains
Sonia AkbarzadehFounder & PartnerFood Industry Consulting, Inc.
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Introduction to cGMPs
Presented by: Sonia Akbarzadeh Msc, Eng.
Food Safety Consultant
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Introduction to GMPsGMPsRoot of any food safety systemContinuous evolving GFSIFSSC 22000, BRC, IFS, SQF, Global Gap FDA food safety modernization Act (FSMA)
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Introduction to GMPsInternationally recognized standards:
GMPs in detailMandatory requirements:
Risk assessmentsValidation
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Introduction to GMPsSchemes vary in: Scope Structure Standards Certification process PopularitySchemes have in commonComprehensive GMPs & HACCP
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Introduction to GMPsGMPs Foundation of HACCP Detailed programs & procedures Control hazards introduced by:
personnel, environment & operations Regulatory requirements countries
products are made & sold in
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Introduction to GMPs4 Stages for Successful GMP Programs:
1. Development - write down what you doRisk assessment
2. Implementation - employee training; providerecourses/tools/equipment
3. Validation - Initial, annually, for changes4. Verification - ensure effectiveness
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Introduction to GMPsPersonnel hazards: Sneezing Illnesses Cuts Infections Dirty hands Dirty clothes Jewelry and loose objects
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Introduction to GMPsEnvironmental hazards Leaking roof Dirty or corroded equipment Non-potable water Pests Poor ventilation Damaged packaging Ingredients received in poor condition
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Introduction to GMPs
Documentation & RecordkeepingControlled documents Document register to include:
oDocument numbersoLatest versionoIssued dateoApproveroLocation (folder & plant)
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Introduction to GMPsDocumentation & Recordkeeping
Managing document changeReason for changeApproval of the new version Old folderReplacing the plant documents
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Introduction to GMPsDocumentation & Recordkeeping
Detailed procedures Verifying recordsRecordkeepingApplicable standardsCustomer requirements Shelf life plus additional one year
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Introduction to GMPsPersonnel Practices Each employeeVisitorContractorTraining Frequency:Once they are hiredAnnually as refresherWhen guidelines are changed
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Introduction to GMPsPersonnel Practices VerificationObservations Inspections on a regular basisVarious shiftsMonthly GMP Internal audit
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Introduction to GMPsPersonnel Practices
Traffic patterns (Employees & Visitors)Site map Hand washing policyUniform policy
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Introduction to GMPsSanitationoComprehensive systemoEffectively remove
Food residues Soil Unacceptable chemical residues
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Introduction to GMPsSanitation Effective cleaning & sanitizingRoomsUtensils EquipmentAvoid cross contaminating
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Introduction to GMPsMaster Sanitation Schedule
To include all the items such as:Overhead & ceilingsWallsVarious equipment AreasRacksLaddersCatwalks & stairsLift trucks
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Introduction to GMPsSanitation program Validation frequency:At the design stageAnnually When any elements changed
Verification:Prior to production
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Introduction to GMPsWater PotabilityAdequateFrom known clean sourceUsed as:Processing aid CleaningIngredientIce
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Introduction to GMPsWater PotabilityWater testing frequency:Minimum annuallyWhen changes in:
SourceDelivery system
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Introduction to GMPsWater PotabilityTesting for:
Heavy metals Bacteria pH Turbidity
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Introduction to GMPsWater map to indicate: Water distribution flows Water holding tank Water treatment location Water recycle if applicable Water sampling points
oTreatment validationoColor coding non-potable water pipes
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Introduction to GMPsPest Control Program
Methods used to control pestsAssigning responsibilityList of pesticides & chemicals-Target pest for each pesticide application Pest elimination method Frequency of inspection. Pest control site map
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Introduction to GMPsPest Control Verification:
Service report for completeness & complianceObserving the pest Control Operator Monthly GMP auditsDaily inspection Pest control company quality assurance
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Introduction to GMPsPest Control Validation
By reviewing:Annual trend report Customer complaintsIncidentsMonthly GMPAudits
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Introduction to GMPsFacility and building design
ConstructionLocationPlant surroundings Prevent contamination
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Introduction to GMPsFacility & building design
Approved materials by the local regulationRegular inspection Elimination of possible contaminations Flow of waste water (Darin map)Inspection of the exterior
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Introduction to GMPsEquipment and Preventive maintenance
Reduce frequency of regular maintenanceReduce emergency repairsProlonging equipment lifespan Reduce downtimesSave timeSave money
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Introduction to GMPsEquipment and Preventive maintenanceAnnual Master PM schedulePreventive maintenance SOPMaintenance checklistWork ordersPost maintenance sanitation procedureDocumenting & investigating equipment failuresControl of temporary repairVerification
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Introduction to GMPsNew equipment
Meets the desired functionIs easy to clean & maintainCan be positioned for ease of cleaning &
operationIts type & design suitable for food production
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Introduction to GMPsReceiving/Storage/Shipping
Storing:Sanitary conditionProper environmental conditions
(Temperature & humidity) Designated areas
Site map
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Introduction to GMPsReceiving/Storage/Shipping Conditions vary depending on : Type Nature Temperature
Such as,• Bulk• Bagged• Refrigerated• Frozen• Packaging materials
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Introduction to GMPs
Receiving/Storage/Shipping Approving contract transport
o Freight questionnaire o Audit
Truck designated for only foodNot for metals, chemicals or glass
transportation
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Introduction to GMPsReceiving/Storage/Shipping Truck inspection prior to downloading & loadingProduct condition inspectionChecklistsList of approved suppliersCriteria for rejecting incoming materialsTrailer breakdown procedureMonitoring temperature if applicableProduct & ingredient identification & color
codeValidation of transportation temperature
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Introduction to GMPsAllergen Control Identification Management Communication Comply with regulation where products made &
sold Such as:Maximum residue limits, food safety, trade weight, packaging, product description, nutrition, additives, allergen labeling, relevant industry codes of practice
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Introduction to GMPsEffective allergen program include:Prevention method Identifying ingredients & products Identifying area and equipment Dedicated storage areaDedicated utensils & color codeChange over cleaning procedure Cleaning verification method Logic production scheduleReviewing labels
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Introduction to GMPsRecall Lot coding raw materials & products Minimizing risk to consumers’ health Fast & efficient procedures Regain control of unsafe products Mock recall
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Introduction to GMPsEffective recall program Recall team Recall coordinator Recall contact list to include:
o Team 24/7o Regulatory authoritieso Standard ownero Certification body o Customers, distributers, supplierso Laboratory, consultants & legal
representative
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Introduction to GMPsEffective recall program Recall forms Mock recallReport to include: Team member name Duties Time spent to finish task Areas of opportunities Action plan
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Introduction to GMPsTrainingGMPs Specific training Training register:Participant nameSkills description Description of the training providedDate of training completionTrainer or training providerSupervisor’s verification
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Introduction to GMPsTraining sign log to include:Subject of the trainingsMaterial usedParticipant names SignaturesDateTrainer name Duration of the training
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Automating Supplier
and Quality Management
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TraceGains Products
Specification Publishing
Create, maintain, and publish your company’s unique specifications to ensure compliance on incoming ingredients.
Supplier Compliance
Automate lot-by-lot compliance across purchasing, COAs,
receiving, testing, and plant floor.
Finished Goods COAs
Generate finished goods COAs, manage
customer-specific formats, and send to
customers on demand.
Supplier Management
Automatically manage supplier qualification,
documents, and relationships.
Quality Management
Automate HACCP / HARPC and comply with GFSI, FSMA, safety, and quality.
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Supplier Analysis& Scorecarding
TraceGains Supplier Management
To-do Lists,Corrective Actions
Access Anywhere,Anytime
Allergens OrganicAudits KosherNutritionSupplier Qualification
FSMA, GFSI, 365 Audit Ready™
C.O.O.L. Specifications
24/7 Monitoring
eNotifications
Labeling(e.g., Genesis)
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TraceGains Quality Management
To-do Lists, Alerts,Corrective Actions
Trends & Graphs
Access Anywhere,Anytime
CCPsPre-op Sanitize, Calibrate, etc.
Verify CCPs Automate FSMA, GFSI Audits & Records
GFSI Documents
FSMA, GFSI, 365 Audit Ready™
Pre-ShipmentCheckoff
Staff Training
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Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits