12.30 20140917 IATA Cool-Chain-Association Regulatory-Standards

IATA Standards: Ensuring compliance to
Regulations for Time & Temperature Sensitive

Air Freight shipments
Ronald Schaefer
September 17th, 2014
Cool Chain Association, Milan
Agenda
 IATA & Air Cargo

 Regulations & Standards
 Solution to Challenges
 Center of Excellence in Pharmaceutical Handling
IATA Standards: Ensuring compliance to Regulations for Time & 2 Milan, September 17, 2014
Temperature Sensitive
IATA & Air Cargo
About IATA
 The International Air Transport Association is the industry’s global trade

association
 Founded in 1945. With 240 members, IATA represents 84% of global air
traffic
 IATA’s mission is to represent, lead and serve the air transport industry
 IATA delivers Standards and Solutions to ensure a successful air

transport
About Air Cargo
 Scheduled air cargo started 90 years ago

with mail
 Essential engine of today’s global
economy and airlines business
 About 48 million tonnes of freight is
transported annually with a value of well
over $5 trillion
 $5 trillion only amounts to 0,5% in volume
but 35% of worldwide value
 Consists of general & special cargo e.g.
perishables, dangerous goods, live animals,
pharmaceuticals, etc.
Industry Cooperation
The Time and Temperature sensitive goods play an important role in this
percentage
Security  With the healthcare market

Safety becoming a key engine of the
Temperature (e.g. global economy, pharmaceutical
Sensitive Dangero
Products us and biomedical industries are
Goods) facing new challenges in adapting
to globalization.
Live
E-Cargo
Animals  Speed to market is therefore
Special essential and the healthcare
Cargo
(ULD, industry is increasingly dependent
Mail) upon air cargo.
Industry Cooperation
Why is air cargo so important?
 Immunization prevents
2.5 million deaths every year
 Air cargo is critical in flying

vaccines to their destination in
time to be effective.
Regulations &
Standards
IATA a standard setting organization
IATA adopted a supply chain approach by liaising with all stakeholders
…
Temperature
Sensitive
IATA
Products Cargo Services Conference (CSC)
Live Animal & Perishable Board

(LAPB)
Time & Temperature Task Force

(TTTF)
Ground Temperature
Freight
Shippers Handlers Airlines Airports controlled
Forwarders packaging
IATA a Standard Setting Organization
…from the health care industry to establish common standards
Temperature
Sensitive
Products
2007 2010 2012 2014

Perishable Cargo PCR Mandatory
Regulations New Chapter T&T Sensitive
(PCR) Industry 17 Label
standard New T&T
Sensitive
Label
2008 2009 2011 2013

Mandatory
Standard
Checklist
IATA - CEIV Pharma 10 Q3 2014
Implementation and Dissemination of Standards
Step 1: Implementation Step 2: Dissemination

Industry feedback driving
improvements:
Support Adoption
 Need for standardization in the
handling of pharmaceutical
Prove Concept
products in air cargo environment
 Need to enhance partnership and
communication Develop
Standards
 Need to ensure appropriate
training in the supply chain
The industry usually asks IATA to address

their needs to ensure compliance and quality services
Dissemination of Standards in the Industry

Challenges and
solutions
Background: Pharmaceutical Product Logistics
The pharmaceutical industry has relied heavily on the airline industry for
its speed and efficiency but air cargo’s share of global pharmaceutical
products transport has dropped
Over the past 10 years, air carriers, handlers and Air cargo’s share of global pharmaceutical
freight forwarders have responded with branded products transport (in %)
products and services to grab a share of this
lucrative and niche market. 17
 An external service provider indicated that: 11

 nearly 100% of vaccines and 68% of biotech
products need to be stored and transported
between 2-8°C.
 48% of diagnostics and 11% of products from large 2000 2013
pharmaceutical companies have to be handled
similarly.
 More than 50% of all temperature excursions occur
while in the package is hands of airlines.
HOWEVER  Annual product losses between US$2.5-12.5 billion

due to various reasons including temperature
excursions during transport and shipping.
Source: Pharmaceutical Commerce
IATA - CEIV Pharma 14 Montreal, September 8, 2014

Critical Issues Raised by the Shippers
Increasing shift in pharmaceuticals transported by sea due to air cargo
challenges
Temperature excursions happen while in the
hands of supply chain partners
 Temperature deviation denature the product,
render it worthless and be harmful to the
health of the patient
 Products can be lost, scrapped, returned
leading to significant costs
Due to a lack of compliance, The use of air-mode

standardization, accountability and transportation is re-considered
transparency across the air unless industry partners ensure
transport supply chain quality services
Air Cargo Supply Chain Challenges
+35°C -10°C
+35°C -10°C
Air Cargo Supply Chain Challenges
The process is quite complex and shippers have difficulties to identify
stakeholders that meet standards and regulations
Example of Flow from BRU to SYD
Shipper Forwarder X Forwarder Y Consignee

BRU SYD
Pick-up In Out In Out In
In Out BRU out SIN in out SYD in In Out
Ground handler BRU Airline BRU – SIN - SYD Ground handler SYD
14 milestones from start to end.
HOW CAN YOU MANAGE THIS ?

Air Cargo Industry Concerns and Challenges
No global certification for handling of pharmaceutical products has led to
increased regulations and audits
Regulations for transporting pharmaceutical products
vary around the world
 Increasing number of regulations
around the world to implement and
comply with
 Increasing number of audits
 Airlines, GHAs and forwarders

subjected to multiple audits for
handling, transportation and
distribution (e.g. WHO Appendix 5, EU
92/25/EEC, IATA PCR Chapter 17 &
TCR)
 No global certification for handling of

pharmaceutical products

Shippers Expectations in Cold Chain
Modal shift is a reality because shippers need products to maintain
integrity and efficacy during transportation
 Compliance, standardization, accountability and
transparency across the supply chain
 Properly trained stakeholders on regulations and

standards
 Adequately equipped facilities throughout the supply chain
 Global certification for handling of pharmaceutical cargo
 Common audit format to minimize the disruptions and

increase effectiveness
 Ability to easily search and identify stakeholders that

meet requirements

Center of Excellence for Independent Validators
Improve together to protect and grow our industry
The Need The solution

 … for more safety, security and  Develop standards with regulators
efficiency
 … to raise the bar to (re)gain confidence  Train industry stakeholders on

standards and regulation
 … to improve compliance to  Assess operations against standard
standards/regulations check list
 … for independent assessments vs.  Train independent validators on

self-assessments standards and regulations
 … to identify and recognize the best  Certify and then register best
players players on a publicly website
 … to harmonize and reduce the number  Get States recognition to ensure

of audits audits are valid for all
Goal of CEIV Pharma
Ensure a higher and more consistent level of pharma handling through
validations and trainings with registered IVs and instructors
EXISTING NEW
1 2 3 4 5
Training Pre- Validation Re-
Standards and
(Recurrent Validation (Audit) & Validation
Regulations
Training) Assessment Award (Re-Audit)*
 Advocate for  Develop training  Develop pre-  Manage deployment  Manage database
globally accepted contents validation of validators of validated
standards and  Develop assessment toolkit  Audit documentation, locations and
regulations assessment criteria  Develop a standard processes and operators
 Establish validation for instructors and validation operations  Manage re-
checklist with validators exam methodology and consistently validation schedule
industry  Train instructors, assessment tool  Manage quality of
 Establish industry validators and validations
steering group industry  Follow-up
stakeholders  Award and recognize
 Manage database operators and
of certified locations as "CEIV
instructors and Pharma certified"
validators

Certification Approach and Methodology
IATA will certify companies in several steps
1 2 3
Preparation Assessment Validation
 Assemble team;  On-site assessment by  On-site visit by an 5
 Prepare project logistics; Independent validator Independent Validator to
review progress made Certification
 Send data and information  Assessment versus
minimum IATA Temperature against recommendations
request; during the assessment
Controlled Audit Checklist ;
 Send interview request phase.
sheet for first visit.  Comparison against best
 Drafting of report.
practice;
 2 weeks before assessment.  Min 6-8 weeks after the
 Establish findings and offer
assessment.
recommendations for
change;
 Develop implementation plan
and secure resources.
 Drafting of report.
Additional
Training: IATA Pharmaceutical Handling Diploma
Training

Assessment
Review, compare against best practice, offer recommendations for
change, identify and mitigate risks, develop implementation plan
Assessment
Criteria applied Issues tackled

 Quality management  Content of manuals and guidelines
 Personnel  Procedures for Audits
 Training  Procedures for describing packaging
systems
 Documentation
 Acceptance checklist quality and operating agreements
 Infrastructure + equipment
 Packaging requirements
 Operations
 Documentation & labeling
 Complaints, returns and counterfeit
 Acceptance & control
 Supplier management
 Facilities and equipment
 Self-inspections
 Staff training requirements
 Transportation
 Training adequacy and currency
 Specific provisions for brokers

Assessment
Focus is on global coverage and universality
Assessment
IATA guidelines Good distribution Local and regional

practices guidelines
E.g. Singapore GDP &

GDPMDS or FAGG in
Belgium
CEIV Pharma
 encompasses various regulations and standards e.g. EU GDP.
 includes in the check list the GDP requirements.
 aims at covering international standards and country-specific requirements.
 aims at reducing the number of audits or simplifying them.
Assessment
CEIV Pharma is looking at a global and consistent GDP+ certification as
the “GDP” is very EU centric and not specific to air transport.
Assessment
 CEIV Pharma aims at global and Local GDP

consistent assessments specific to air regula-
transport encompassing international tions
standards as well as national regulations.
TCR
 Some areas, such as ground and tarmac
transportation, aircraft (un)loading are
not covered by GDPs
The goal being to have a network of

certified trade-lanes assessed
consistently.
Validation
Validate if recommendations have been implemented
Validation
Review of progress on action plan
 On-site visit by Independent Validators to review progress made against recommendations during the
assessment phase.
 At the end of validation decision on whether all requirements have been fulfilled
Training: IATA Pharmaceutical Handling Diploma
The diploma includes 4 pharmaceutical specialized courses. Upon
successful completion of the 4 courses, the participants will obtain an
IATA Diploma.
Training: IATA
Pharmaceutical Handling
Diploma
Temperature Temperature Risk Management of Audit and Quality of

Controlled Controlled Container Temperature Controlled Temperature Controlled
Cargo Handling Operations Cargo Cargo
2 key personnel involved in handling pharmaceutical products activities should be trained and pass
the examination of the 4 courses of the “IATA Pharmaceutical Handling Diploma” - before the
certification

Additional Training
Introduction to Time and Temperature Pharmaceutical Products
Additional Training
4-6 hours training. Key topics:

 Pharmaceutical products
 Processes & procedures related to job functions
 Identification and labelling
 Effect of temperature on pharmaceutical products
 Avoidance of counterfeits
 Passive and active packing
 Product security
All personnel involved in handling pharmaceutical products activities per station should be trained
on “IATA Introduction to Time and Temperature Pharmaceutical Products course“ (or equivalent))
within period of 12 months after the “Certification”

Path to certification
Assessment
Step 1
Training
Step 2
Validation
Step 3
Certification!!!
Training (remaining staff)

Step 4
Certification
Award Certificate "CEIV Pharma Certified"

Example
SATS Coolport Pilot Project
Handover ceremony in February 2014

Certification Timeline (general approach)
2-8
Preparation 2 weeks Assessment Validation
weeks
2-4 days on- 2-4 days on-

site site
Timeframe
depends on Certifi-
results of cation
assessment.
Training: IATA Pharmaceutical Handling Additional

Diploma Training
2-8 weeks
 Ideally completed before 12 months
assessment. after
 Needs to be completed before certification
validation.
CEIV Pharma Certification Approach
There are different approaches to obtain certification
 “Individual” approach: One company decides to get "CEIV

Pharma Certified"
 “Community” approach: A group of companies at an airport

decide to get "CEIV Pharma Certified" to form a “pharma gateway”
 “Coalition” approach: A group of companies decide to get "CEIV

Pharma Certified" at several airports to form several “pharma
gateways”

Advocacy governance
Strong emphasis on engaging stakeholder and advocate for
endorsement and recognition
WHO? TASK
Industry
 Approve standards
 Time and Temperature Task Group –
 Approve trainings
CEIV Pharma Steering Group
Global
 WHO  Global shippers forum (GSF)
 FIACA  Cool Chain Association
 TIACA  ICQP
 Endorse + recognize
Regional standards
 US GDP
 EU
 Endorse + recognize
Local trainings
 Local stakeholder associations
(Shippers, Freight Forwarders,
Ground Handlers, Airlines)
 Local BARs
CEIV Pharma – Who’s is auditing?
Qualification and management of independent validators
Qualification Management
 IATA conducts preliminary  IVs are registered in IATA
interview with candidate to pre- database and available to
qualify candidate for training complete the assessments and
validations
 IVs must undergo IATA training
and need to obtain the Diploma  Coordination of IVs is
for Pharma Handling managed by the IATA
Consulting team for
 IVs need to complete Diploma assessments and validations
within six months
 IV cannot have been in a
 IV’s can also become commercial relationship with
instructors but need to entity to be validated 12 months
undergo the IATA Train-the- prior to the engagement.
trainer course (optional)
Recertification
Recertification will take place every two year – includes assessment and
one refresher training plus a validation if necessary
"CEIV Pharma
Certified" 
Re-assessment

2 years 2 - 4 days
X Close gaps Validation
1 - 2 days
One Refresher
Training
 e.g. update on new regulations, development on new

standards, development of new containers, etc.
CEIV Pharma – Key Benefits
The CEIV Pharma is a win-win situation for the industry
Shippers Airlines, GHAs, Forwarders, Airports
 Conduct simpler audits of operators  Protect and grow revenues in fastest
 Obtain guarantee that products would be growing segment of air cargo
handled in line with regulations  Obtain recognition for operations, facilities
 Experience lower rate of damage and loss and staff after meeting standards
due to temperature excursions  Experience simpler audits from various
 Be able to prepare their products ready for organizations
acceptance  Promote their best practices to the shipper’s
community
Regulators IATA
 Assured of safety of pharmaceutical  Disseminated standards in the industry
products shipped by air  Common audit criteria and global
 Access structured and consistent training certification
and registry of independent validators and  Promote air transport and so limit the modal
assessed operators shift
Transforming Challenges into Success
The importance of partnerships
THANK YOU

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IATA Standards: Ensuring compliance to

Regulations for Time & Temperature Sensitive

 IATA & Air Cargo

 The International Air Transport Association is the industry’s global trade

 IATA delivers Standards and Solutions to ensure a successful air

 Scheduled air cargo started 90 years ago

Security  With the healthcare market

 Air cargo is critical in flying

Live Animal & Perishable Board

Time & Temperature Task Force

2007 2010 2012 2014

2008 2009 2011 2013

Step 1: Implementation Step 2: Dissemination

The industry usually asks IATA to address

IATA - CEIV Pharma 12 Q3 2014

 An external service provider indicated that: 11

HOWEVER  Annual product losses between US$2.5-12.5 billion

IATA - CEIV Pharma 14 Montreal, September 8, 2014

Due to a lack of compliance, The use of air-mode

Shipper Forwarder X Forwarder Y Consignee

Pick-up In Out In Out In

In Out BRU out SIN in out SYD in In Out

14 milestones from start to end.

HOW CAN YOU MANAGE THIS ?

 Increasing number of audits

 Airlines, GHAs and forwarders

 No global certification for handling of

IATA - CEIV Pharma 18 Montreal, September 8, 2014

 Properly trained stakeholders on regulations and

 Adequately equipped facilities throughout the supply chain

 Global certification for handling of pharmaceutical cargo

 Common audit format to minimize the disruptions and

 Ability to easily search and identify stakeholders that

IATA - CEIV Pharma 19 Montreal, September 8, 2014

The Need The solution

 … to raise the bar to (re)gain confidence  Train industry stakeholders on

 … for independent assessments vs.  Train independent validators on

 … to harmonize and reduce the number  Get States recognition to ensure

IATA - CEIV Pharma 21 Montreal, September 8, 2014

IATA - CEIV Pharma 22 Q3 2014

Criteria applied Issues tackled

IATA - CEIV Pharma 23 Montreal, September 8, 2014

IATA guidelines Good distribution Local and regional

E.g. Singapore GDP &

 CEIV Pharma aims at global and Local GDP

The goal being to have a network of

Review of progress on action plan

Temperature Temperature Risk Management of Audit and Quality of

IATA - CEIV Pharma 27 Q3 2014

4-6 hours training. Key topics:

IATA - CEIV Pharma 28 Q3 2014

Training (remaining staff)

Award Certificate "CEIV Pharma Certified"

IATA - CEIV Pharma 31 Q3 2014

2-4 days on- 2-4 days on-

Training: IATA Pharmaceutical Handling Additional

 “Individual” approach: One company decides to get "CEIV

 “Community” approach: A group of companies at an airport

 “Coalition” approach: A group of companies decide to get "CEIV

IATA - CEIV Pharma 33 Q3 2014

 e.g. update on new regulations, development on new

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