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Css 2013 temperature controlled transport - risk mitigation - luc huybreghts - pauwels consulting

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Css 2013 temperature controlled transport - risk mitigation - luc huybreghts - pauwels consulting

  1. 1. TEMPERATURE CONTROLLED TRANSPORTA RISK MITIGATION APPROACHACCORDING TO EU GDPLuc HuybreghtsSr. QA ConsultantPauwels Consulting
  2. 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 www.pconsulting.net 2
  3. 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 www.pconsulting.net 3
  4. 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 www.pconsulting.net 4
  5. 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 5
  6. 6. TRANSPORT – RISK ASSESSMENT (1) RISK ASSESSMENT: remaining risks  What – destinations – how – duration – handover points  External conditions: climate zones – availability of services www.pconsulting.net 6
  7. 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 www.pconsulting.net 7
  8. 8. TRANSPORT – RISK ASSESSMENT (3) Make a score  Scoring criteria : severity & probability www.pconsulting.net 8
  9. 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 www.pconsulting.net 9
  10. 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 www.pconsulting.net 10
  11. 11. TRANSPORT – STRATEGY (1)STRATEGY: from risk identification to risk mitigation Changes in distribution system 11
  12. 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 www.pconsulting.net 12
  13. 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 www.pconsulting.net 13
  14. 14. TRANSPORT – QUALIFICATION (1) End UserManufacturing Storage Distribution (patient) Controlled environment Variable environment Validation Qualification www.pconsulting.net 14
  15. 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 www.pconsulting.net 15
  16. 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 www.pconsulting.net 16
  17. 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 17
  18. 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 www.pconsulting.net 18
  19. 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 www.pconsulting.net 19
  20. 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 www.pconsulting.net 20
  21. 21. FOR MORE INFORMATION:  luc.huybreghts@pconsulting.net  www.pconsulting.net 21

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