1. TEMPERATURE CONTROLLED TRANSPORT
A RISK MITIGATION APPROACH
ACCORDING TO EU GDP
Luc Huybreghts
Sr. QA Consultant
Pauwels Consulting

2. GDP = GOOD DISTRIBUTION PRACTICES
 GDP regulations = set of basic requirements
with different chapters providing more
detailed information on
 All activities consisting of
procuring, holding, supplying or exporting
medicinal products
 Distributors and manufacturers, who do their
own distribution must comply with the
principles & guidelines of GDP
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3. GDP – GENERAL
 The regulatory attitude continues to evolve:
 No longer about “Cold Chain” – its about Good Storage and
Distribution Practices, throughout the entire supply chain and at
various temperatures
 Complete supply chain Integrity – from manufacturer to the
patient with a focus on Quality Management
 A contiguous supply network with Quality/Service Level
Agreements
 Emphasis on preventive measures
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4. GDP – WHY?
 Distribution: important activity in integrated supply chain
 globalisation
 complex – many players
 covers all storage & distribution throughout the supply chain
 Quality & integrity of medicinal products must be guaranteed
 quality – adulteration
 security – falsified products
 adequate control is necessary
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5. MAP YOUR PROCESS
 Know your product: galenic form – packaging – specifications
 Know the capabilities of your partners – transport mode -
route
Warehouse temp. Warehouse temp. Warehouse DHL temp.
controlled +15°C/+25°C controlled +15°C/+25°C controlled +15°C/+25°C
Patheon Latina
Manufacturing Packaging
Canada Temp. Italy
Controlled Airport
Airport Toronto Airport Brussels
Airport Temp.
Warehouse Truck Controlled
Warehouse +15°C/+25°C Truck
Patheon Warehouse Latina temp.
temp.Contr. +15°C/+25°C Warehouse
Controlled +15°C/+25°C
+15°C/+25°C
Temperature controlled storage
Temperature controlled transport
Unloading
Temperature controlled storage
Limited exposure
Temperature controlled service
Limited exposure
Temperature controlled storage
Loading
Temperature controlled transport
Temperature controlled storage
Loading
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6. TRANSPORT – RISK ASSESSMENT (1)
 RISK ASSESSMENT: remaining risks
 What – destinations – how – duration – handover points
 External conditions: climate zones – availability of services
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7. TRANSPORT – RISK ASSESSMENT (2)
 Different techniques: Fishbone - FMEA
 Probability
 Stability data of your product
 Weather data
 Lane information: duration – handover points – delivery
 Severity
 Risk for the patient
 Regulatory
 Business continuity
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8. TRANSPORT – RISK ASSESSMENT (3)
 Make a score
 Scoring criteria : severity & probability
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9. TRANSPORT – RISK ASSESSMENT (4)
 Risk score = Probability x Severity
 Define your risk level(s)
 Example:
Severity / 2 4 6 8 10
Probability
2 4 8 12 16 20
4 8 16 24 32 40
6 12 24 36 48 60
8 16 32 48 64 80
10 20 40 60 80 100
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10. TRANSPORT – RISK ASSESSMENT (5)
 Apply risk score to: product groups – lanes – transport mode
 Risk Matrix: (example)
Product group Lane Mode Probability Severity Risk score
Controlled /
uncontrolled
A Mfg US - pack. IT sea controlled 2 4 8
A pack. IT - EDC BE air uncontrolled 6 4 24
EDC Belgium to
A DC Spain road controlled 2 2 4
B Mfg US - pack. IT air controlled 2 10 20
B pack. IT - EDC BE air controlled 2 10 20
EDC Belgium to
B DC Spain road controlled 2 6 12
C Mfg US - pack. IT sea controlled 2 8 16
C pack. IT - EDC BE air uncontrolled 6 8 48
EDC Belgium to
C DC Spain road controlled 2 6 12
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11. TRANSPORT – STRATEGY (1)
STRATEGY: from risk identification to risk mitigation
 Changes in distribution system
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12. TRANSPORT – STRATEGY (2)
 Processes under control
 Road: temperature controlled trucks
 Ocean: reefer containers
 Air:
 active & passive shippers
 limited number of pre-defined carriers
 direct flights as much as possible
 defined routes
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13. TRANSPORT – DESIGN
 DESIGN: reducing the risks
 carrier selection and audit
 detailed SLA with carriers (quality requirements), partnership
 qualified equipment - routes
 protective packaging: thermal blankets
 route verification
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14. TRANSPORT – QUALIFICATION (1)
End User
Manufacturing Storage Distribution
(patient)
Controlled environment Variable environment
Validation Qualification
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15. TRANSPORT – QUALIFICATION (2)
 Approach:
 FTL – LTL: same carriers – same family of equipment
 Qualification FTL: family approach
 Combination of:
 cool units & trailer suppliers
 matrix of equipment to be used
 one trailer per family fully qualified
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16. TRANSPORT – QUALIFICATION (3)
 Approach: different families based on
TRAILER COOLUNIT COOLUNIT type
supplier supplier
Schmitz Thermoking Spectrum SLX
Chereau Carrier Vector 1850 S2
 Starting requirements:
 ATP certification
 calibration certificates
 maintenance schedule/records
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17. TRANSPORT – QUALIFICATION (5)
Impact Assessment
User Requirements
Qualification Plan (PQP)
• Vehicle identification
Installation • Specifications
• Verification
Qualification • Availability procedures
• Calibration verification
• Controller parameters
Operational • Temperature mapping
• Empty/loaded
Qualification • Single/dual
• Diesel/electrical
• Power failure test
• Door open test
• Alarm verification
• Auto start verification
Performance Qualification • # runs routine shipping
lane
• Hot & cold season
• Max & min. load
Final Qualification Report
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18. TRANSPORT – CONTROL
 CONTROL SYSTEMS: for remaining risk areas
 Monitoring = part of the puzzle
 Temperature monitoring of trucks – reefer containers – active shippers
– thermal protected shipments
 Time monitoring
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19. TRANSPORT – QUALITY SYSTEM
 PERIODICAL REVIEW: annual transport report
 yearly review of:
 calibration certificate
 ATP – certificate
 # transports
 # deviations
 COC: evaluation of the changes
 equipment
 route
 product
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20. TRANSPORT – LESSONS LEARNED
 Product knowledge: enough stability data
 Risk analysis – risk mitigation
 Qualification where possible
 Build up a good relationship with your partners:
 Capabilities – QA agreements/SLA
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21. FOR MORE INFORMATION:
 luc.huybreghts@pconsulting.net
 www.pconsulting.net
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