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

Alan Dorling Global Head – Pharmaceuticals & Life Sciences

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

Key Goal of Time & Temperature Air Cargo Shipments

+15ºC to +25ºC

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

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

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

•  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

IATA  Ch.17  

EU  GDP  2013/C  343/01  

Chapter  <1083>  Good  DistribuBon  PracBce  

FDAsia  Food  &  Drug  AdministraBon  Safety  

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

Quality Management

System

Dedicated

Global Product Vertical Team & Regional Sales

Specialists IATA Ch.17 & GDP Trained

E-platform, Comms &

technology

Infrastructure Improvement & Capability

Knowledge & Expertise

Improved customer

experience & awareness

Improved Operational Capability

Key Transhipment Hubs LHR & MAD

Temperature Controlled

Capabilities

Quality Management System

IAG Cargo Quality Management System

Shipper/Manufacturer Requirements

Proc

ess

& P

roce

dure

s

Doc

umen

ts &

Rec

ords

Fac

ilitie

s

E

quip

men

t & M

ater

ials

Pe

ople

, Tra

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Co

mpe

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Revi

ew &

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Regulatory Requirements

•  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

TTSF Quality Management system for Air Cargo

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

15ºC to 25ºC

David  Shepherd  Head  of  Commercial  

Alan  Dorling  Global  Head  of  

PharmaceuBcals    &  Life  Sciences  

Loranne  Vella-­‐Zahra  Global  Quality  

Assurance  Manager  

David  Allen  Global  Training  

Manager  

Fernando  Terol  GM  Spanish  Hub  &  

OperaBons  

Chris  Warren  Global  Product  

Manager  

Pere  Valbuena  Product  Delivery  &  Customer  Experience  

Jose  Ramon  del  Rio  Quality  Manager  

(MAD)  

Marta  Beamud  Product  Delivery  

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)

Global Vertical Team

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  

North  America    

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)    

Montreal  (YUL)  Toronto  (YYZ)    

UK,  Ireland  and  Europe    

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)  

Africa,  Middle  East  and  Asia    

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

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)  

IAG  Cargo  Constant  Climate  Network  (98)  

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

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)  

•  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

Maximising Service Performance

Future of Pharmaceutical TTS air cargo •  Regulatory environment becoming increasingly demanding requiring significant capital

investment

•  There are penalties to not complying

•  Damage to customer/market perception of your product or company

•  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 alan.dorling@ba.com +44(0)7500-767854 (mobile)