Best Practices in Air Cargo Supply Chain Pharmaceuticals in the Cool Chain Conference 2014 Malpensa

Alan Dorling Global Head – Pharmaceuticals & Life Sciences

Key Goal of Time & Temperature Air Cargo Shipments

To prevent any risk of a temperature excursion whilst in the supply chain for a Pharmaceutical or any other temperature sensitive shipment resulting in a loss of purity, potency or stability of the drug that would result in a patient not be administered the medicine Quality is the bedrock underpinning a successful Air Cargo Service

+15ºC to +25ºC

Highest Stated Customer Needs for Time & Temperature Sensitive Product Shipments IQPC Cold Chain Temperature Management Forum PHL

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Qualification and Validation: What quality assurances do I have that my cargo will arrive safely with no temperature excursions or cross contamination?

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Breadth and Depth of service network: How wide is your network and to how many locations can you safely ship my temperature –sensitive cargo?

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Monitoring & Communication: How easy is it for my order to be placed and my shipment to be monitored once it enters the air-freight supply chain?

Highest Stated Customer Concerns

Source: Pharma iQ Pharma Supply Chain 360 Report 2014

Most temperature deviations occur during transportation

Increasing Regulations for TTSF EU  GDP  2013/C  343/01  

IATA  Ch.17  

FDAsia  Food  &  Drug  AdministraBon  Safety  

Chapter    Good  DistribuBon  PracBce  

Good Manufacturing and Distribution Practice - GMDP • 

Good Cold Chain Management is an integration of several processes that are either enforced by legislation or adopted through guidelines.

Regulation is changing practice & cost!

Air Cargo Best Practice Delivery Strategy Dedicated Global Product Vertical Team & Regional Sales Specialists IATA Ch.17 & GDP Trained Key Transhipment Hubs LHR & MAD

Improved Operational Capability Temperature Controlled Capabilities

Knowledge & Expertise

Quality Management System Infrastructure Improvement & Capability

E-platform, Comms & technology

Improved customer experience & awareness

Quality Management System IAG Cargo Quality Management System

Regulatory Requirements

Review & Checks

People, Training & Competence

Equipment & Materials

Facilities

Documents & Records

Process & Procedures

Shipper/Manufacturer Requirements

TTSF Quality Management system for Air Cargo

•  •  •  •  •  •  •  •  • 

IATA Ch.17 Perishable Cargo Regulations EU GDP Guidelines 2013/C 68/01 - 2013/C 343/01 SOP Active Shipments ACT SOP Passive Shipments PCT SOP CAPAs Network Station LOPs Initial and Annual Training Annual Audits by network station Quality Managers Network Station Risk Assessments

Best Practice – Use IATA Label & Pre-Alert Booking Form for every shipment

15ºC to 25ºC

Global Vertical Team

David  Allen   Global  Training   Manager  

David  Shepherd   Head  of  Commercial  

Fernando  Terol   GM  Spanish  Hub  &   OperaBons  

Alan  Dorling   Global  Head  of   PharmaceuBcals    &  Life   Sciences  

Pere  Valbuena   Product  Delivery  &   Customer  Experience  

Loranne  Vella-­‐Zahra   Global  Quality   Assurance  Manager  

Chris  Warren   Global  Product   Manager  

Jose  Ramon  del  Rio   Quality  Manager   (MAD)  

Carole  Madigan   Container  Leasing   ExecuBve   Constant Climate Team leaders x6 (LHR)

CC Sales Specialists Jez Palmer (UK&I) Olivier Pringuey (S+E Eur) Stefan Metzen (N+C Eur) Stephen Soltanovici (N Am) Stephanie Kardos (N Am) Rashmi Karnad (India) Shiv Sivaraman (A Pac)

Marta  Beamud   Product  Delivery  

Air Carrier’s Best Practice - Infrastructure & Fleet

•  Temperature Controlled Warehouses •  Minimise Tarmac exposure risk •  Temperature controlled cargo holds •  Global networks with excellent connectivity

Partnering  across  a  global  network  

IAG  Cargo  Constant  Climate  Network  (98)   Central  and  South  America    

AnBgua  (ANU)   Mexico  City  (MEX)   Guatemala  City  (GUA)   Panama  City  (PTY)   San  Jose  (SJO)   San  Juan  (SJU)    

Bogota  (BOG)   Buenos  Aires  (EZE)   Caracas  (CCS)   Lima  (LIM)     Rio  de  Janeiro  (GIG)   Sao  Paulo  (GRU)   SanBago  (SCL)  

North  America  

UK,  Ireland  and  Europe  

Africa,  Middle  East  and  Asia  

Atlanta  (ATL)   Boston  (BOS)   Chicago  (ORD)   Dallas  (DFW)   Denver  (DEN)   Houston  (IAH)   Los  Angeles  (LAX)   Miami  (MIA)   Newark  (EWR)   New  York  (JFK)   Orlando  (MCO)   Philadelphia  (PHL)   Phoenix  (PHX)   Sea`le  (SEA)   San  Diego  (SAN)   San  Francisco  (SFO)   Tampa  (TPA)   Washington  (IAD)  

Belfast  (BFS)   Cork  (ORK)   Dublin  (DUB)   Glasgow  (GLA)   London  -­‐  Gatwick  (LGW)   London  -­‐  Heathrow  (LHR)   London  -­‐  Luton  (LTN)   Manchester  (MAN)   Shannon  (SNN)   Amsterdam  (AMS)   Athens  (ATH)   Barcelona  (BCN)   Basel  (BSL)   Brussels  (BRU)   Budapest  (BUD)   Copenhagen  (CPH)   Frankfurt  (FRA)   Geneva  (GVA)   Istanbul  (IST)   Larnaca  (LCA)   Las  Palmas  (LPA)   Lisbon  (LIS)   Lyon  (LYS)   Madrid  (MAD)   Milan  (MXP)   Moscow  (DME)   Munich  (MUC)   Munster  Osnabruck  (FMO)   Muscat  (MCT)   Paris  (CDG)   Prague  (PRG)   Rome  (FCO)   Stu`gart  (STR)   Tel  Aviv  (TLV)   Vienna  (VIE)   Zurich  (ZRH)  

Cairo  (CAI)   Johannesburg  (JNB)   Lagos  (LOS)   Luanda  (LAD)  

 

 

Montreal  (YUL)   Toronto  (YYZ)    

For more information on station capabilities and facilities please contact your local IAG Cargo Sales Team..

 

 

 

Abu  Dhabi  (AUH)   Bahrain  (BAH)   Doha  (DOH)   Dubai  (DXB)   Kuwait  (KWI)   Riyadh  (RUH)    

Bangalore  (BLR)   Chennai  (MAA)   Delhi  (DEL)   Hyderabad  (HYD)   Mumbai  (BOM)    

Bangkok  (BKK)   Beijing  (PEK)   Chengdu  (CTU)   Hong  Kong  (HKG)     Shanghai  (PVG)   Singapore  (SIN)   Tokyo  -­‐  Haneda  (HND)   Tokyo  -­‐  Narita  (NRT)   Seoul  (ICN)    

Melbourne  (MEL)   Sydney  (SYD)  

Maximising Service Performance •  Communication & collaboration is key to drive shared goals and needs •  Transparency allows for proper decision making •  Invest in vertical teams with expert knowledgeable people across the entire process •  Regulatory compliant Quality Management Systems & SOPs are needed for carriage of Time & Temperature Sensitive Shipments •  Demonstrate ability to deliver bespoke transportation requirements •  Needed awareness for on-going training throughout all steps of air conveyance •  Continuing legislation development will result in minimizing risk to Time & Temperature Sensitive Shipments – expect to commit further capital investment to be a top tier air carrier

Future of Pharmaceutical TTS air cargo • 

Regulatory environment becoming increasingly demanding requiring significant capital investment

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There are penalties to not complying

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Damage to customer/market perception of your product or company

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Dealing with partners who are GDP compliant will become more important than cost alone

• 

Gives assurances to patients that their treatment will be efficacious and safe

Best practice is thinking inside the box!

Thank you

Alan Dorling – Global Head Pharmaceuticals & Life Sciences [email protected] +44(0)7500-767854 (mobile)