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Intro to cGMPs:
The Building Blocks for
GFSI Compliance
Sonia Akbarzadeh
Founder & Partner
Food Industry Consulting, Inc.
Rajan Gupta
VP Customer Success
TraceGains
Sonia Akbarzadeh
Founder & Partner
Food Industry Consulting, Inc.
Introduction to cGMPs
Presented by:
Sonia Akbarzadeh Msc, Eng.
Food Safety Consultant
Introduction to GMPs
GMPs
Root of any food safety system
Continuous evolving
GFSI
FSSC 22000, BRC, IFS, SQF, Global Gap
FDA food safety modernization Act (FSMA)
Introduction to GMPs
Internationally recognized standards:
 GMPs in detail
Mandatory requirements:
 Risk assessments
Validation
Introduction to GMPs
Schemes vary in:
 Scope
 Structure
 Standards
 Certification process
 Popularity
Schemes have in common
Comprehensive GMPs & HACCP
Introduction to GMPs
GMPs
 Foundation of HACCP
 Detailed programs & procedures
 Control hazards introduced by:
personnel, environment & operations
 Regulatory requirements countries
products are made & sold in
Introduction to GMPs
4 Stages for Successful GMP Programs:
1. Development - write down what you do
Risk assessment
2. Implementation - employee training; provide
recourses/tools/equipment
3. Validation - Initial, annually, for changes
4. Verification - ensure effectiveness
Introduction to GMPs
Personnel hazards:
 Sneezing
 Illnesses
 Cuts
 Infections
 Dirty hands
 Dirty clothes
 Jewelry and loose objects
Introduction to GMPs
Environmental hazards
 Leaking roof
 Dirty or corroded equipment
 Non-potable water
 Pests
 Poor ventilation
 Damaged packaging
 Ingredients received in poor condition
Introduction to GMPs
Documentation & Recordkeeping
Controlled documents
Document register to include:
oDocument numbers
oLatest version
oIssued date
oApprover
oLocation (folder & plant)
Introduction to GMPs
Documentation & Recordkeeping
Managing document change
Reason for change
Approval of the new version
Old folder
Replacing the plant documents
Introduction to GMPs
Documentation & Recordkeeping
Detailed procedures
Verifying records
Recordkeeping
Applicable standards
Customer requirements
Shelf life plus additional one year
Introduction to GMPs
Personnel Practices
Each employee
Visitor
Contractor
Training Frequency:
Once they are hired
Annually as refresher
When guidelines are changed
Introduction to GMPs
Personnel Practices Verification
Observations
Inspections on a regular basis
Various shifts
Monthly GMP
Internal audit
Introduction to GMPs
Personnel Practices
Traffic patterns (Employees & Visitors)
Site map
Hand washing policy
Uniform policy
Introduction to GMPs
Sanitation
oComprehensive system
oEffectively remove
 Food residues
 Soil
 Unacceptable chemical residues
Introduction to GMPs
Sanitation
Effective cleaning & sanitizing
Rooms
Utensils
Equipment
Avoid cross contaminating
Introduction to GMPs
Master Sanitation Schedule
To include all the items such as:
Overhead & ceilings
Walls
Various equipment
 Areas
Racks
Ladders
Catwalks & stairs
Lift trucks
Introduction to GMPs
Sanitation program
Validation frequency:
At the design stage
Annually
When any elements changed
Verification:
Prior to production
Introduction to GMPs
Water Potability
Adequate
From known clean source
Used as:
Processing aid
Cleaning
Ingredient
Ice
Introduction to GMPs
Water Potability
Water testing frequency:
Minimum annually
When changes in:
Source
Delivery system
Introduction to GMPs
Water Potability
Testing for:
 Heavy metals
 Bacteria
 pH
 Turbidity
Introduction to GMPs
Water map to indicate:
 Water distribution flows
 Water holding tank
 Water treatment location
 Water recycle if applicable
 Water sampling points
oTreatment validation
oColor coding non-potable water pipes
Introduction to GMPs
Pest Control Program
Methods used to control pests
Assigning responsibility
List of pesticides & chemicals-
Target pest for each pesticide application
Pest elimination method
Frequency of inspection.
Pest control site map
Introduction to GMPs
Pest Control Verification:
Service report for completeness &
compliance
Observing the pest Control Operator
Monthly GMP audits
Daily inspection
Pest control company quality assurance
Introduction to GMPs
Pest Control Validation
By reviewing:
Annual trend report
Customer complaints
Incidents
Monthly GMP
Audits
Introduction to GMPs
Facility and building design
Construction
Location
Plant surroundings
Prevent contamination
Introduction to GMPs
Facility & building design
Approved materials by the local regulation
Regular inspection
Elimination of possible contaminations
Flow of waste water (Darin map)
Inspection of the exterior
Introduction to GMPs
Equipment and Preventive maintenance
Reduce frequency of regular maintenance
Reduce emergency repairs
Prolonging equipment lifespan
Reduce downtimes
Save time
Save money
Introduction to GMPs
Equipment and Preventive maintenance
Annual Master PM schedule
Preventive maintenance SOP
Maintenance checklist
Work orders
Post maintenance sanitation procedure
Documenting & investigating equipment failures
Control of temporary repair
Verification
Introduction to GMPs
New equipment
 Meets the desired function
Is easy to clean & maintain
Can be positioned for ease of cleaning &
operation
Its type & design suitable for food production
Introduction to GMPs
Receiving/Storage/Shipping
Storing:
Sanitary condition
Proper environmental conditions
(Temperature & humidity)
Designated areas
Site map
Introduction to GMPs
Receiving/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 food
Not for metals, chemicals or glass
transportation
Introduction to GMPs
Receiving/Storage/Shipping
Truck inspection prior to downloading & loading
Product condition inspection
Checklists
List of approved suppliers
Criteria for rejecting incoming materials
Trailer breakdown procedure
Monitoring temperature if applicable
Product & ingredient identification & color
code
Validation of transportation temperature
Introduction to GMPs
Allergen 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 GMPs
Effective allergen program include:
Prevention method
Identifying ingredients & products
Identifying area and equipment
Dedicated storage area
Dedicated utensils & color code
Change over cleaning procedure
Cleaning verification method
Logic production schedule
Reviewing labels
Introduction to GMPs
Recall
 Lot coding raw materials & products
 Minimizing risk to consumers’ health
 Fast & efficient procedures
 Regain control of unsafe products
 Mock recall
Introduction to GMPs
Effective recall program
 Recall team
 Recall coordinator
 Recall contact list to include:
o Team 24/7
o Regulatory authorities
o Standard owner
o Certification body
o Customers, distributers, suppliers
o Laboratory, consultants & legal
representative
Introduction to GMPs
Effective recall program
 Recall forms
Mock recall
Report to include:
 Team member name
 Duties
 Time spent to finish task
 Areas of opportunities
 Action plan
Introduction to GMPs
Training
GMPs
Specific training
Training register:
Participant name
Skills description
Description of the training provided
Date of training completion
Trainer or training provider
Supervisor’s verification
Introduction to GMPs
Training sign log to include:
Subject of the trainings
Material used
Participant names
Signatures
Date
Trainer name
Duration of the training
For more info
please visit us:
www.food-industry.ca
Automating
Supplier
and Quality
Management
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.
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)
TraceGains Quality Management
To-do Lists, Alerts,
Corrective Actions
Trends & Graphs
Access Anywhere,
Anytime
CCPs
Pre-op Sanitize,
Calibrate, etc.
Verify CCPs Automate FSMA, GFSI
Audits & Records
GFSI
Documents
FSMA, GFSI, 365 Audit Ready™
Pre-Shipment
Checkoff
Staff Training
Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
Rajan Gupta
rajan.gupta@tracegains.com
www.tracegains.com
Sonia Akbarzadeh
Sonia@food-industry.ca
888-406-5554
www.food-industry.ca

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Intro to cGMPs: The Building Blocks for GFSI Compliance

  • 1. Intro to cGMPs: The Building Blocks for GFSI Compliance Sonia Akbarzadeh Founder & Partner Food Industry Consulting, Inc.
  • 2. Rajan Gupta VP Customer Success TraceGains Sonia Akbarzadeh Founder & Partner Food Industry Consulting, Inc.
  • 3. Introduction to cGMPs Presented by: Sonia Akbarzadeh Msc, Eng. Food Safety Consultant
  • 4. Introduction to GMPs GMPs Root of any food safety system Continuous evolving GFSI FSSC 22000, BRC, IFS, SQF, Global Gap FDA food safety modernization Act (FSMA)
  • 5. Introduction to GMPs Internationally recognized standards:  GMPs in detail Mandatory requirements:  Risk assessments Validation
  • 6. Introduction to GMPs Schemes vary in:  Scope  Structure  Standards  Certification process  Popularity Schemes have in common Comprehensive GMPs & HACCP
  • 7. Introduction to GMPs GMPs  Foundation of HACCP  Detailed programs & procedures  Control hazards introduced by: personnel, environment & operations  Regulatory requirements countries products are made & sold in
  • 8. Introduction to GMPs 4 Stages for Successful GMP Programs: 1. Development - write down what you do Risk assessment 2. Implementation - employee training; provide recourses/tools/equipment 3. Validation - Initial, annually, for changes 4. Verification - ensure effectiveness
  • 9. Introduction to GMPs Personnel hazards:  Sneezing  Illnesses  Cuts  Infections  Dirty hands  Dirty clothes  Jewelry and loose objects
  • 10. Introduction to GMPs Environmental hazards  Leaking roof  Dirty or corroded equipment  Non-potable water  Pests  Poor ventilation  Damaged packaging  Ingredients received in poor condition
  • 11. Introduction to GMPs Documentation & Recordkeeping Controlled documents Document register to include: oDocument numbers oLatest version oIssued date oApprover oLocation (folder & plant)
  • 12. Introduction to GMPs Documentation & Recordkeeping Managing document change Reason for change Approval of the new version Old folder Replacing the plant documents
  • 13. Introduction to GMPs Documentation & Recordkeeping Detailed procedures Verifying records Recordkeeping Applicable standards Customer requirements Shelf life plus additional one year
  • 14. Introduction to GMPs Personnel Practices Each employee Visitor Contractor Training Frequency: Once they are hired Annually as refresher When guidelines are changed
  • 15. Introduction to GMPs Personnel Practices Verification Observations Inspections on a regular basis Various shifts Monthly GMP Internal audit
  • 16. Introduction to GMPs Personnel Practices Traffic patterns (Employees & Visitors) Site map Hand washing policy Uniform policy
  • 17. Introduction to GMPs Sanitation oComprehensive system oEffectively remove  Food residues  Soil  Unacceptable chemical residues
  • 18. Introduction to GMPs Sanitation Effective cleaning & sanitizing Rooms Utensils Equipment Avoid cross contaminating
  • 19. Introduction to GMPs Master Sanitation Schedule To include all the items such as: Overhead & ceilings Walls Various equipment  Areas Racks Ladders Catwalks & stairs Lift trucks
  • 20. Introduction to GMPs Sanitation program Validation frequency: At the design stage Annually When any elements changed Verification: Prior to production
  • 21. Introduction to GMPs Water Potability Adequate From known clean source Used as: Processing aid Cleaning Ingredient Ice
  • 22. Introduction to GMPs Water Potability Water testing frequency: Minimum annually When changes in: Source Delivery system
  • 23. Introduction to GMPs Water Potability Testing for:  Heavy metals  Bacteria  pH  Turbidity
  • 24. Introduction to GMPs Water map to indicate:  Water distribution flows  Water holding tank  Water treatment location  Water recycle if applicable  Water sampling points oTreatment validation oColor coding non-potable water pipes
  • 25. Introduction to GMPs Pest Control Program Methods used to control pests Assigning responsibility List of pesticides & chemicals- Target pest for each pesticide application Pest elimination method Frequency of inspection. Pest control site map
  • 26. Introduction to GMPs Pest Control Verification: Service report for completeness & compliance Observing the pest Control Operator Monthly GMP audits Daily inspection Pest control company quality assurance
  • 27. Introduction to GMPs Pest Control Validation By reviewing: Annual trend report Customer complaints Incidents Monthly GMP Audits
  • 28. Introduction to GMPs Facility and building design Construction Location Plant surroundings Prevent contamination
  • 29. Introduction to GMPs Facility & building design Approved materials by the local regulation Regular inspection Elimination of possible contaminations Flow of waste water (Darin map) Inspection of the exterior
  • 30. Introduction to GMPs Equipment and Preventive maintenance Reduce frequency of regular maintenance Reduce emergency repairs Prolonging equipment lifespan Reduce downtimes Save time Save money
  • 31. Introduction to GMPs Equipment and Preventive maintenance Annual Master PM schedule Preventive maintenance SOP Maintenance checklist Work orders Post maintenance sanitation procedure Documenting & investigating equipment failures Control of temporary repair Verification
  • 32. Introduction to GMPs New equipment  Meets the desired function Is easy to clean & maintain Can be positioned for ease of cleaning & operation Its type & design suitable for food production
  • 33. Introduction to GMPs Receiving/Storage/Shipping Storing: Sanitary condition Proper environmental conditions (Temperature & humidity) Designated areas Site map
  • 34. Introduction to GMPs Receiving/Storage/Shipping Conditions vary depending on :  Type  Nature  Temperature Such as, • Bulk • Bagged • Refrigerated • Frozen • Packaging materials
  • 35. Introduction to GMPs Receiving/Storage/Shipping Approving contract transport o Freight questionnaire o Audit Truck designated for only food Not for metals, chemicals or glass transportation
  • 36. Introduction to GMPs Receiving/Storage/Shipping Truck inspection prior to downloading & loading Product condition inspection Checklists List of approved suppliers Criteria for rejecting incoming materials Trailer breakdown procedure Monitoring temperature if applicable Product & ingredient identification & color code Validation of transportation temperature
  • 37. Introduction to GMPs Allergen 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
  • 38. Introduction to GMPs Effective allergen program include: Prevention method Identifying ingredients & products Identifying area and equipment Dedicated storage area Dedicated utensils & color code Change over cleaning procedure Cleaning verification method Logic production schedule Reviewing labels
  • 39. Introduction to GMPs Recall  Lot coding raw materials & products  Minimizing risk to consumers’ health  Fast & efficient procedures  Regain control of unsafe products  Mock recall
  • 40. Introduction to GMPs Effective recall program  Recall team  Recall coordinator  Recall contact list to include: o Team 24/7 o Regulatory authorities o Standard owner o Certification body o Customers, distributers, suppliers o Laboratory, consultants & legal representative
  • 41. Introduction to GMPs Effective recall program  Recall forms Mock recall Report to include:  Team member name  Duties  Time spent to finish task  Areas of opportunities  Action plan
  • 42. Introduction to GMPs Training GMPs Specific training Training register: Participant name Skills description Description of the training provided Date of training completion Trainer or training provider Supervisor’s verification
  • 43. Introduction to GMPs Training sign log to include: Subject of the trainings Material used Participant names Signatures Date Trainer name Duration of the training
  • 44. For more info please visit us: www.food-industry.ca
  • 46. 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.
  • 47. 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)
  • 48. TraceGains Quality Management To-do Lists, Alerts, Corrective Actions Trends & Graphs Access Anywhere, Anytime CCPs Pre-op Sanitize, Calibrate, etc. Verify CCPs Automate FSMA, GFSI Audits & Records GFSI Documents FSMA, GFSI, 365 Audit Ready™ Pre-Shipment Checkoff Staff Training
  • 49. Automation Solves Many Problems GFSI Labeling FSMA Audits