Intro to cGMPs:The Building Blocks for

GFSI ComplianceSonia AkbarzadehFounder & Partner

Food Industry Consulting, Inc.

Rajan GuptaVP Customer SuccessTraceGains

Sonia AkbarzadehFounder & PartnerFood Industry Consulting, Inc.

Introduction to cGMPs

Presented by: Sonia Akbarzadeh Msc, Eng.

Food Safety Consultant

Introduction to GMPsGMPsRoot of any food safety systemContinuous evolving GFSIFSSC 22000, BRC, IFS, SQF, Global Gap FDA food safety modernization Act (FSMA)

Introduction to GMPsInternationally recognized standards:

GMPs in detailMandatory requirements:

Risk assessmentsValidation

Introduction to GMPsSchemes vary in: Scope Structure Standards Certification process PopularitySchemes have in commonComprehensive GMPs & HACCP

Introduction to GMPsGMPs Foundation of HACCP Detailed programs & procedures Control hazards introduced by:

personnel, environment & operations Regulatory requirements countries

products are made & sold in

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

Introduction to GMPsPersonnel hazards: Sneezing Illnesses Cuts Infections Dirty hands Dirty clothes Jewelry and loose objects

Introduction to GMPsEnvironmental hazards Leaking roof Dirty or corroded equipment Non-potable water Pests Poor ventilation Damaged packaging Ingredients received in poor condition

Introduction to GMPs

Documentation & RecordkeepingControlled documents Document register to include:

oDocument numbersoLatest versionoIssued dateoApproveroLocation (folder & plant)

Introduction to GMPsDocumentation & Recordkeeping

Managing document changeReason for changeApproval of the new version Old folderReplacing the plant documents

Introduction to GMPsDocumentation & Recordkeeping

Detailed procedures Verifying recordsRecordkeepingApplicable standardsCustomer requirements Shelf life plus additional one year

Introduction to GMPsPersonnel Practices Each employeeVisitorContractorTraining Frequency:Once they are hiredAnnually as refresherWhen guidelines are changed

Introduction to GMPsPersonnel Practices VerificationObservations Inspections on a regular basisVarious shiftsMonthly GMP Internal audit

Introduction to GMPsPersonnel Practices

Traffic patterns (Employees & Visitors)Site map Hand washing policyUniform policy

Introduction to GMPsSanitationoComprehensive systemoEffectively remove

Food residues Soil Unacceptable chemical residues

Introduction to GMPsSanitation Effective cleaning & sanitizingRoomsUtensils EquipmentAvoid cross contaminating

Introduction to GMPsMaster Sanitation Schedule

To include all the items such as:Overhead & ceilingsWallsVarious equipment AreasRacksLaddersCatwalks & stairsLift trucks

Introduction to GMPsSanitation program Validation frequency:At the design stageAnnually When any elements changed

Verification:Prior to production

Introduction to GMPsWater PotabilityAdequateFrom known clean sourceUsed as:Processing aid CleaningIngredientIce

Introduction to GMPsWater PotabilityWater testing frequency:Minimum annuallyWhen changes in:

SourceDelivery system

Introduction to GMPsWater PotabilityTesting for:

Heavy metals Bacteria pH Turbidity

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

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

Introduction to GMPsPest Control Verification:

Service report for completeness & complianceObserving the pest Control Operator Monthly GMP auditsDaily inspection Pest control company quality assurance

Introduction to GMPsPest Control Validation

By reviewing:Annual trend report Customer complaintsIncidentsMonthly GMPAudits

Introduction to GMPsFacility and building design

ConstructionLocationPlant surroundings Prevent contamination

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

Introduction to GMPsEquipment and Preventive maintenance

Reduce frequency of regular maintenanceReduce emergency repairsProlonging equipment lifespan Reduce downtimesSave timeSave money

Introduction to GMPsEquipment and Preventive maintenanceAnnual Master PM schedulePreventive maintenance SOPMaintenance checklistWork ordersPost maintenance sanitation procedureDocumenting & investigating equipment failuresControl of temporary repairVerification

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

Introduction to GMPsReceiving/Storage/Shipping

Storing:Sanitary conditionProper environmental conditions

(Temperature & humidity) Designated areas

Site map

Introduction to GMPsReceiving/Storage/Shipping Conditions vary depending on : Type Nature Temperature

Such as,• Bulk• Bagged• Refrigerated• Frozen• Packaging materials

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

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

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

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

Introduction to GMPsRecall Lot coding raw materials & products Minimizing risk to consumers’ health Fast & efficient procedures Regain control of unsafe products Mock recall

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

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

Introduction to GMPsTrainingGMPs Specific training Training register:Participant nameSkills description Description of the training providedDate of training completionTrainer or training providerSupervisor’s verification

Introduction to GMPsTraining sign log to include:Subject of the trainingsMaterial usedParticipant names SignaturesDateTrainer name Duration of the training

For more info please visit us:

www.food-industry.ca

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and Quality Management

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Rajan Gupta

rajan.gupta@tracegains.comwww.tracegains.com

Sonia Akbarzadeh

Sonia@food-industry.ca888-406-5554

www.food-industry.ca