TEMPERATURE CONTROLLED TRANSPORT A RISK MITIGATION APPROACH ACCORDING TO EU GDP Luc Huybreghts Sr. QA Consultant Pauwels Consulting
Css 2013 temperature controlled transport - risk mitigation - luc huybreghts - pauwels consulting
May 25, 2015
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TEMPERATURE CONTROLLED TRANSPORT
A RISK MITIGATION APPROACHACCORDING TO EU GDP
Luc HuybreghtsSr. QA ConsultantPauwels Consulting
www.pconsulting.net
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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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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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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PatheonCanada Temp.
ControlledTruck
+15°C/+25°C
Airport Toronto
Warehouse temp. controlled +15°C/+25°C
Warehouse Latina temp.Controlled +15°C/+25°C
Airport Brussels
Warehouse temp. controlled +15°C/+25°C
Warehouse DHL temp. controlled +15°C/+25°C
Temp. Controlled
Truck+15°C/+25°C
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Packaging
Warehouse
Airport Airport
Warehouse
Manufacturing
Know your product: galenic form – packaging – specifications Know the capabilities of your partners – transport mode -
route
MAP YOUR PROCESS
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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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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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Make a score Scoring criteria : severity & probability
TRANSPORT – RISK ASSESSMENT (3)
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Risk score = Probability x Severity Define your risk level(s) Example:
Severity / Probability
2 4 6 8 10
2 4 8 12 16 204 8 16 24 32 406 12 24 36 48 608 16 32 48 64 80
10 20 40 60 80 100
TRANSPORT – RISK ASSESSMENT (4)
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Apply risk score to: product groups – lanes – transport mode Risk Matrix: (example)
Product group Lane Mode Controlled / uncontrolled
Probability Severity Risk score
A Mfg US - pack. IT sea controlled 2 4 8A pack. IT - EDC BE air uncontrolled 6 4 24
AEDC Belgium to DC Spain road controlled 2 2 4
B Mfg US - pack. IT air controlled 2 10 20B pack. IT - EDC BE air controlled 2 10 20
BEDC Belgium to DC Spain road controlled 2 6 12
C Mfg US - pack. IT sea controlled 2 8 16C pack. IT - EDC BE air uncontrolled 6 8 48
CEDC Belgium to DC Spain road controlled 2 6 12
TRANSPORT – RISK ASSESSMENT (5)
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STRATEGY: from risk identification to risk mitigation
Changes in distribution system
TRANSPORT – STRATEGY (1)
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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
TRANSPORT – STRATEGY (2)
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DESIGN: reducing the risks carrier selection and audit detailed SLA with carriers (quality requirements), partnership qualified equipment - routes protective packaging: thermal blankets route verification
TRANSPORT – DESIGN
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TRANSPORT – QUALIFICATION (1)
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Variable environment
QualificationValidation
Controlled environment
Manufacturing StorageEnd User(patient)
Distribution
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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
TRANSPORT – QUALIFICATION (2)
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Approach: different families based on
Starting requirements: ATP certification calibration certificates maintenance schedule/records
TRAILER supplier
COOLUNIT supplier
COOLUNIT type
Schmitz Thermoking Spectrum SLX
Chereau Carrier Vector 1850 S2
TRANSPORT – QUALIFICATION (3)
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User Requirements
Qualification Plan (PQP)
Impact Assessment
Installation Qualification
• Vehicle identification• Specifications• Verification • Availability procedures
Operational Qualification
• Calibration verification• Controller parameters• Temperature mapping
• Empty/loaded• Single/dual • Diesel/electrical
• Power failure test• Door open test• Alarm verification• Auto start verification
TRANSPORT – QUALIFICATION (5)
Performance Qualification • # runs routine shipping lane
• Hot & cold season• Max & min. load
Final Qualification Report
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CONTROL SYSTEMS: for remaining risk areas Monitoring = part of the puzzle
Temperature monitoring of trucks – reefer containers – active shippers – thermal protected shipments
Time monitoring
TRANSPORT – CONTROL
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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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Product knowledge: enough stability data Risk analysis – risk mitigation Qualification where possible Build up a good relationship with your partners:
Capabilities – QA agreements/SLA
TRANSPORT – LESSONS LEARNED
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