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Page 1: DHL TEMPERATURE MANAGEMENT SOLUTIONS

PUBLIC

DHL TEMPERATURE MANAGEMENT SOLUTIONS

DHL Global Forwarding

PUBLIC

Page 2: DHL TEMPERATURE MANAGEMENT SOLUTIONS

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2

Cuéntenos que necesita, que nosotros nos ocupamos del resto!

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3

DHLSameDay LIFE SCIENCES

•On-Demand Solutions

•Expedited Global

Network (>200 countries and territories)

•24/7/365 Operations | Control

Tower | Intervention management

•Extensive Life Sciences Customers Base

•Thousands of Life Sciences Expedited Shipments

•Dangerous Goods

•Expertise

IATA DGR

Privacy (Medical Courier)

ISO 9001:2015 (IMS)

EU-GDP

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4

Los siguientes son los factores integrantes del producto estàndard de

cadena fria – DHL Air Thermonet

DHL Air Thermonet – 5 elementos claves del producto

DHL THERMONET y sus 5 elementos esenciales

1 2 3 4 5

Red de estaciones Calidad & Cumplimiento

regulatorio Plataforma informàtica cSOPs Visibilidad &Monitoreo

• Cumplimiento de las

GDP específico de LS

QMS1 (anexo al

manual de calidad de

DGF)

• Programa específico

de gestión de

proveedores de LS

(compañías aéreas,

proveedores de

camiones)

• Proceso de certificación

y auditoría central

Standard DGF AFR Temperature

Management Service –

DHL Air Thermonet

• Estaciones Certificadas para

el manejo de Material

Farmacèutico (Centros de

Competencia): dirección

operativa central y

estandarización de la red

• Todas las estaciones

certificadas con los requisitos

mínimos Personas:

Especialistas en Ciencias de

la Vida certificados, basados

en materiales de capacitación

estándar mundial Procesos de

Manejo Auditado e

instalaciones calificadas

definidas en base a

estándares centrales

• Diseñado específicamente

para la Industria:LifeTrack

• Una única fuente de datos

integrada de cadena de frío

(SOP, RFID, HAWB,

información de seguimiento

y rastreo)

• Una vez que se recopilan

suficientes datos permitirá

una mejora continua

• Especificación de la

temperatura y

requisitos de empaque

• Diseño e

implementación de

SOP específicos (por

linea de transporte)

• Gestión automatizada

de cambios SOP y

gestión de documentos

/ control de versiones

• Planificación de

contingencias

• El equipo de

Monitoreo de DHL

TMS es capaz de

supervisar e

intervenir

proactivamente

todos los envíos

24/7/365

• Apoyados por DHL

Smart Sensor

tambien se puede

mapear

temperatura de

transporte.

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5

DHL Air Thermonet Global

Network

Cobertura TNX

Estacio-

nes

Actuales (2017)

32 IATA CEIV

117

Bajo

Consideracion 2

BRU

YYZYUL

MIARDU

ORD

CVGLAX

PHL

BOS

SJUMEX

PTY

BOG

CCS

VLNSJO

SAO(VCP/GRU)

RIO

SFO

BUE

DUBORK

SNNMAN

MAD BCN

PAR, LYS, SXB

IND

ROMMIL

BSL, GVA, ZRHVIE

LNZ

AMS

MUC, STRFRA, HAM, LEJ

CPH

MLA

CAI

STO

HEL

IST

TLV

LON

JNB

MEL

SYD

PEK

SHA

TYOSEL

TPEHKG

SIN

AKL

MNLBKK

KUL

MOW (DME/SVO)

BOM

HYD

BLR

DEL

DXB

MVD

NBO

DCA

JKT(CGK)

JFK

ATL OSA NGO

LOS

CAN

SZX

CPT

MSP

PER

IAH

SGN

LIM

DFW

CGN BER BFE/FMO

BUD

BRU

AMD

DHL Air Thermonet – IATA CEIV. Red de estaciones certificadas

SCL

GUA

BOD

UIO

LJU

CMB

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Calidad y Cumplimiento Regulatòrio

Estàndares Globales formalizados, entregas dentro del marco

regulatorio; en una red operativa certificada y auditable

• Sistema de gestión de la calidad compatible con las GXP específico de la Industria Farmacèutica

• Programa específico de gestión de proveedores de Ciencias de Vida.

• Análisis post-envío y acciones correctivas y preventivas

• Gestión de reclamaciones de clientes

• Proceso de certificación y auditoría central

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Estàndares globales formalizados, cumpliendo con el marco

regulatòrio sobre los procesos, auditorias operativas de las estaciones.

Quality Organisation Structure:

Global QualityTraining & Supplier Mgmt Certification &

Audit Regulatory Compliance

Regional QualityProcess & Quality Compliance

Station QualityDHL Air Thermonet Product Manager

EXPORT

IMPORT

WAREHOUSE

QUALITY

CONTROL

DHL AIR

THERMONET

Estructura de Calidad y Cumplimiento Regulatòrio

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Cold Chain Design & Implementation

Un simple programa para el diseño de los SOPs, sus

implementaciones, control documental y control de cambios automatizados

control SOP su diseño y manejos son críticos

• Especificación de la temperatura y

requisitos de empaque.

• Diseño e implementación de SOP

específicos (por linea de transporte)

• Plantillas estándar para múltiples

productos y necesidades de envío

• Gestión automatizada del cambio SOP

• Gestión de documentos y control de

versiones

Proceso de aprobación del sistema antes

del envío Planificación de contingencias

Equipo Central de Apoyo

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LifeTrack: Visibilidad global

• DHL Air Thermonet utiliza ‘LifeTrack’, proporsionando un sistema integrado el

cual tecnica y funcionalmente cumple con los requisitos regulatorios de la

21CFR11 FDA

• LifeTrack - Visibilidad global y acceso a través de la red de estaciones certificadas LS & H

• Las estaciones LS & H certificadas DHL tienen acceso a módulos

• LifeTrack específicos

• Buscador de LifeTrack / Herramienta SOP /

• Seguimiento de envíos LifeTrack contiene los

siguientes datos: Clientes y contactos ,Productos y

embalaje,Tradelanes de envío y SOPs

• Cumplimiento de tránsito de embarque por SOP

incluyendo timestamps e información de temperatura,

• Datos de monitoreo de la temperatura ambiente RFID

• Acceso del cliente a LifeTrack:

Información relevante como sus SOPs

Datos de seguimiento de envíos

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Por què elegir DHL Air Thermonet?

Tecnología móvil de primera clase. Nuestra

aplicación LifeTrack proporciona datos de

envío, alertas sobre cualquier problema en

tránsito, y proporciona soporte instantáneo a

través del acceso 24 horas al día a los

expertos en cadena de frío.

La aplicación LifeTrack está disponible en

las tiendas de aplicaciones de iTunes y

Google Play.

Acceder a la aplicación con el mismo registro de

detalles como el navegador web Detalles del envío

incluyendo ruta, hitos del movimiento e

intervenciones potenciales mostradas al finalizar

los eventos logísticos clave o la detección de

posibles irregularidades. La aplicación informa al

usuario y también proporciona detalles sobre las

medidas tomadas cuando sea necesario

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Visibilidad y Monitoreo

Siguiendo el proceso, 17 eventos incluyendo 4 posibles escaneos de

los RFIDs – Hitos monitoreados por el equipo de Monitoreo

SST scan of

temperature

data (ambient or

near-product)

Warehouse /

Dist Center

ConsigneeShipper DGF Import LSCCDGF Export LSCC Origin Carrier Destination Carrier

1. Departure or

pick up from

shipper

2. Receipt by

export

forwarder

3. Storage at

export

forwarder

4. Delivery to

carrier

5. Carrier

acceptance

7. Departure

from origin

8. Arrival at

transit point

11. Arrival at

destination

12. Storage at

destination

carrier

14. Recovery

by import

forwarder

15. Storage at

import

forwarder

16. Goods out

for delivery

17. POD

13. Import

clearance

9. Storage at

transit point

10. Departure

from transit

point

6. Storage at

origin carrier

Temperature

Data to LifeTrack

for Global

Monitoring & local

CSSV Teams

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Visibilidad y Monitoreo: proceso con los RFIDs

ShipperDGF Export LSCC Origin Carrier Destination Carrier DGF Import LSCC

Warehouse /

Dist Center

Consignee

En total hasta cuatro lecturas de los SmartSensor podràn proveer visibilidad sobre la

cadena de frio en los embarques DHL Air Thermonet

Example of an ambient temperature read for

Envirotainer RKN

Key points for usage of SmartSensors for THERMONET

One SmartSensor RFID per shipment (HAWB)

Ambient temperature monitored as standard

Attach & Start of SST at DGF Export LSCC

Last temperature read at DGF Import LSCC

SST will stay with shipment until POD

LSCCs will be equipped with 3 SST Mobile Reader

LSCCs will hold a small stock of SSTs

Temperature data automatically send to LifeTrack

No temperature visibility for customers before POD

SST Mobile Readers can operate with FSI

WiFi Network or GSM SIM Card needed on-site to

operate SST Mobile Reader

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DHL SmartSensor BluLog NFC

Simplicity in temperature monitoring.

Time Savings:temperature data available withinseconds after upload

Simple to Use: Can be scanned by any NFC capable mobile phone and App.

Plug and Play Solution:no software installation needed, sensorspre-programmed and ready to use

Pharmaceutical requirements:fulfils regulations EU GMP Annex 11,US 21 CFR Part 11 and EU GDP

Individual Tracking:sensors can be linked to individualshipment IDs

Secure Monitoring:highly secure web platform and encrypted data transmission

Proactive Alert Notification:via e-mail or SMS at various events

Web portalSensor Reading devices

Wireless Upload

NFC - Technology

WARE-

HOUSE

OCEAN

AIR

ROAD

Temperature Monitoring with

DHL SmartSensor RFID

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Smart Sensors. Sobres que incluyen el proceso de logistica reversa.

En un esfuerzo por aumentar el número de SmartSensor escaneados en destino, estamos implementando un nuevo

proceso de devolución de sobre para todos los envíos de Thermonet y LifeConEx. A partir de ahora, todos los nuevos

pedidos de sensores se enviarán con sobres preajustados con franqueo pagado. El sobre tendrá instrucciones al dorso en

inglés, español, chino y francés, ordenando al destinatario que coloque el sobre en el buzón al recibirlo. Los sobres irán al

equipo de SmartSensor en Alemania que escaneará y subirá los datos al portal. Todos los sobres tendrán una etiqueta

identificando el sensor # dentro y la fecha de caducidad del sensor.

Data Loggers Technology

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Visibilidad y Monitoreo: LifeTrack / SST Link

By mouse-over the touch point details on a dotted line will be shown in a pop

up window without temperature information

Touch point:

Storage at export forwarder

Temperature: No reading

Location: Miami

Date: 01.07.2012 – 09:12

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Por què elegir DHL Air Thermonet?

Su socio logístico operando una plataforma

única y robusta a través de la red, en la

cual los clientes pueden contar con un

equipo altamente profesional y dedicado

que monitorea diligentemente su envío a

través de cada etapa de su viaje.

Cobertura operacional básica en todas las

regiones, a través de más de 90 principales

ubicaciones de DHL Global Forwarding en

6 continentes

Nuestro equipo central de monitoreo que

opera 24/7/365 para monitoreo proactivo e

intervención

Expertos certificados de Ciencias de la Vida

y de la Salud para intervenir si es necesario

Programa específico de gestión de

proveedores de Life Sciences

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Por què elegir DHL Air Thermonet?

Visibilidad y cumplimiento de la red

Estándares globales, que

proporcionan procesos compatibles con

las GDP y una red auditada.

Buenas pràcticas de instalaciones

compatibles que proporcionan

cobertura a más de 5.000 rutas.

Visibilidad del envío a través de hasta

17 puntos de contacto

Consistencia global a través de DHL Air

Thermonet GDP. Un único programa

para el diseño, implementación y

control automatizado de documentos

Opción de planificación de contingencia

integrada en SOP de clientes,

productos y rutas de transporte

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18[insert_title] [insert_location] [insert_date]

Why you should choose DHL Air Thermonet

Best in class technology

Our DHL Air Thermonet’s IT system ‘LifeTrack’ is

technically and functionally compliant with

21CFR11

• SmartSensor RFID technology monitors

shipment temperature along the transportation

chain at designated checkpoints

• In-transit ambient temperature monitoring

• Automated SOP change management and

version control

• SOPs serve as the basis for shipment monitoring

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En estos slides, les compartiremos como DHL

utiliza sus herramientas de data analytics para

servir y dar soporte a la Industria de Ciencias de

Vida a fin de mitigar los riesgos en el transporte

aéreo de productos con temperatura controlada

Temperature-sensitive Air Freight – Cómo utilizamos la data para mitigar el riesgo?

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20Delivering Healthcare to the World | DHL TEMPERATURE MANAGEMENT SOLUTIONS | 05FEB18

La escucha activa de nuestros clientes y sus necesidades, es la

principal razón

Hemos recibido requerimientos desde el interés analítico; hasta la

necesidad consultiva para la evaluación de la categorización del riesgo en

la cadena de transporte.…

“How quickly can

you visualize risk

across our key trade

lanes?”

“When do you provide

trade lane risk

assessments, during

the quotation or

implementation

process?”

“Can you provide

trade lane risk

assessments

throughout our

entire network?”

“Can you give

us further risk

consultation

with your

trade lane risk

assessment?”

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Desencadenantes para la búsqueda de Soluciones Analiticas

Requerimientos regulatórios, interés de nuestros clientes; y el creciente

advenimiento del big data, nos motivaron a desarrollar acciones

consistentes.

Triggers

Regulatory Requirements: higher pressure on

customers from regulators

Big Data Opportunities: high amount of operational

data available for analysis

Voice of Customers: inquiries for risk management

solutionsFMEA

LRA

Predictive

Analytics

Analytics Approach

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La disponibilidad de la data va creciendo en forma exponencial; siendo

un gran desafio y una gran oportunidad al mismo tiempo.

Big Data Availability Volume Growth DHL Big Data Survey Results

“…60% of the respondents stated that they are planning to invest in Big Data analytics within the next five years.” 1)

8%

Satisfied

92%

“92% of executives from companies that are applying big data to their businesses said they are

satisfied with the results” 2

Exponential data growth between 2010 and 20201

Big Data Market Players

Company Use of big data

Commercialized the use of existing movement data1)

Weather simulation model used to offer a new

insurance product1)

New predictive models can identify 24% of accounts

expected to close in the next 4 months3)

Structured and unstructured data helps identify

potential fraud3)

New

Pro

duct

Harn

essin

g

Exis

ting D

ata

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Hay una transformación en la categorización del riesgo

Criterion Origin Transit Destination Average

Risk

Factor

Weight

Factor

Temperature

Profile

Assessments

Airport50 50 25 42 10%

Country

Location 1 1 1 1 5%

Customs25 25 25 25 15%

Summer/

Winter 75 75 75 75 5%

Infrastructure

Risk

Station50 50 125 75 5%

Carrier50 50 50 50 10%

Forwarde

r Station 125 50 50 75 20%

Customs25 25 25 25 10%

Packaging

Performance

Validatio

n 1 1 125 42 5%

CAPA1 1 1 1 10%

Temp

Range 25 25 50 33 5%

Average 42 100 %

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LRA – Lane Risk Assessment (factores)

La automatización y la plataforma tecnológica detrás del DHL's trade lane

risk assessment; ofrece mejores capacidades que otras opciones de

mercado

Lane Risk Assessment

Excel-based

assessment of

trade lane risk,

requiring manual

updates

Trade Lane Risk Assessment (LRA)

• Automatic assessment

• Calculated in DHL’s supply chain

intelligence tool, rather than Excel

Differentiating

Factors

Source: DHL Consulting

LRA

Available in Market

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Elementos de riesgo

La matriz de Risk Score va del 1 al 5, y se asigna un valor a cada uno de los elementos claves.

Factores de peso (1, 1.5 or 2) son asignados a cada uno de los elementos clave para permitir evaluar

el impacto en la cadena de transporte y poder contar un “risk priority number” por perfil estacional.

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TRADE LANE RISK ASSESSMENT: SOLUCION EN DETALLE

26

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DHL THERMONET SOP – incluye una matriz por perfil estacional y

línea de transporte

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ConExion es nuestra herramienta analitica exclusive para la Industria.

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Final thought

“Hiding within those mounds of data is knowledge that

could change the life of a patient, or change the world.”

Atul J. Butte Stanford School of Medicine

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Our Experience

+99.9% +9000+18330Successful Delivery

Rate

TradelanesStandard Operating

Procedures

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THANK YOU

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32

Arlete Gago

Cold Chain Director Latin America

DHL Temperature Management Solutions

Thermonet / LifeConEx

Mobile +54 911 60286114

[email protected]

Carlos M. Della Paulera 265,

Ciudad de Buenos Aires

Argentina

Contact

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SUPPORT SLIDES

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34[insert_title] [insert_location] [insert_date]

Case study # 1: DHL Air Thermonet

DHL Air Thermonet was introduced, providing greater visibility

and control of their Pharma products. Through DHL Air

Thermonet’s LifeTrack software each shipment is now

monitored, which means that corrective actions can be taken if

temperature excursions are reported, and the Q&A team can be

ready to inspect these shipments on their arrival, speeding up the

process of product release to market.

Since using DHL Air Thermonet the tough environmental

conditions of Puerto Rico have been managed with no Corrective

and Preventative Actions being reported. All temperature

controlled lanes won from Belgium and Switzerland to Rest of

the World will now move by DHL Air Thermonet.

• Greater shipment visibility and control through LifeTrack. Near real

time visibility on up to 17 touch points from collection through to

delivery

• Products shipped 15C to 25C are pro-actively managed.

Contingencies defined in SOP’s to manage temperature deviations

• Advanced notification of temperature excursions allow faster

response by Q&A team to inspect product readiness before release

Solution Value to customer

A global Pharmaceutical leader with franchises in Immunology, Infectious Diseases and

Oncology. Manufacturing injectables, raw materials and API’s in Puerto Rico, product is then

shipped within a +15C to 25C temperature range to Brussels for European consumption. With

annual origin & destination ground temperatures ranging from -2C to +31C degrees,

experience of product sitting on the tarmac at origin and extended Q&A inspection on arrival, a

higher level of temperature control management was required

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35[insert_title] [insert_location] [insert_date]

Case study # 2: DHL Air Thermonet

DHL Air Thermonet was introduced, and provided a GDP

compliant process and audited network for their Pharma

products. In addition DHL Air Thermonet’s LifeTrack software

gave them shipment visibility 24/7/365.

Through the creation of a lane specific SOP, the customer and

DHL could control all aspects of their products transport from

collection through to delivery. With their standards increasing,

DHL Air Thermonet’s Corrective And Preventive Action policy

confirmed our attention to quality and compliance.

With Pharma products from Hungary now shipped by DHL Air

Thermonet the next origins in scope are Poland, Czech, Croatia

and the US

• A fully compliant network that meets EU Regulations

• Products shipped 15C to 25C are pro-actively managed.

Contingencies defined in SOP’s to manage temperature deviations

• Customers achieve greater shipment visibility and control through

LifeTrack. Near real time visibility on up to 17 touch points from

collection through to delivery

Solution Value to customer

One of the world’s top 10 pharmaceutical companies, producing a wide range of generic and

innovative medicines. 90% of their products are moved under passive packaging solutions

(mainly thermal blankets) and in a +15C to 25C temperature range, 10% are shipped using

RKN & RAP active solutions. With the introduction of new European Union GDP Guidelines

their products required higher pharmaceutical standards.

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36[insert_title] [insert_location] [insert_date]

Case study # 3: DHL Air Thermonet

By switching to DGF, the customer obtained the integrity and

regulatory compliance they were looking for. By introducing DHL

Air Thermonet to the organization, we were able to establish

higher visibility via LifeTrack and 24/7/365 proactive monitoring

and intervention based on their product and lane specific SOP.

The client’s needs are fully covered through DHL Air

Thermonet’s established network of Certified Life Sciences

Stations, Certified Life Sciences Specialists,

IT platform, and SmartSensor technology. They now aim to

become the world leader in at least four major medicinal

treatment categories within the next

ten years.

• A standardized service with global reach

• A stringent and auditable compliant process, ensuring product

integrity

• Anywhere, at any time, reporting and visibility to their product within

our cutting-edge technology – LifeTrack

• Greater control of their product handling

Solution Value to customer

One of the world’s leading pharmaceutical companies, producing a range

of vaccines designed to fight disease in important areas of medical need, required visibility on

shipments. Utilizing active containers with a temperature range of +2C to +8C on two key

trade lanes, their current service provider was not delivering the visibility on touch points

critical to the transportation of their products.

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Frequently asked questions

What’s the advantage

of DHL Air Thermonet

over other cold-chain

solutions?

Some of the key advantages of DHL Air Thermonet include the GDP compliant

network, market leading cold chain platform LifeTrack, proactive monitoring and

intervention at up to 17 touch points, and integrated SOP management.

Do you cover all the

locations I need to

ship to?

DHL Air Thermonet operates between 2000 point pairs globally, so we’re likely to be in

your locality – but it’s not just about scale. We have invested in creating more than 90

Certified Life Sciences Stations and will be investigating further locations in every

region of the world to route and monitor your shipments for ultimate reliability.

Do you use 3rd

Party Shippers?

As with most global forwarders, we rely on 3rd party suppliers, who must meet our

stringent Life Sciences supplier management requirements.

What happens if

something goes

wrong with the

temperature of my

shipment?

The greatest strength of the DHL Air Thermonet service is in the highly trained

proactive monitoring and intervention team that monitors your shipments around the

world 24/7/365. At the first sign of any deviation from agreed parameters, the team

will contact our nearest on-site cold-chain trained specialists to intervene and quickly

resolve the issue. Additionally, this central team can intervene directly if necessary to

address non-compliance

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Frequently asked questions

How can you ensure

my shipments will be

handled consistently

in different

countries?

The key principle of DHL Air Thermonet is that it is based on one robust and audited

operating process. It is managed by a network of skilled, centrally trained specialists

working to a globally consistent standard and utilizing an exclusive IT platform. By

minimizing local practices, DHL Air Thermonet can deliver an unprecedented level of

synchronicity and security.

Is it expensive to use

DHL Air Thermonet?

DHL Air Thermonet is very cost competitive. Any additional cost of using DHL Air

Thermonet can quickly be offset through the savings achieved

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39[insert_title] [insert_location] [insert_date]

Meeting GDP Requirements with DHL Air Thermonet

• A network of

facilities managed

and compliant to

DGF’s GDP

standards

• Centrally trained

and certified

personnel at origin

and destination

• One robust and

auditable

operating process

• A single QMS with

DGF GDP guidelines

embedded into the

processes

• Defined program for

managing logistics

partners / suppliers

within the supply chain

• Audit and Certification

processed centrally

steered for global

compliance

• All shipments

monitored against

an agreed SOP

• 24/7/365 global

proactive

monitoring and

intervention centers

• In transit RFID

temperature data

and event tracking

using 17 touch

points door to door

• LifeTrack: One global IT

platform throughout the

network

• A compliant, single

source platform for all

logistics events and

temperature data needs

• Assurance and ease for

root cause and continual

improvement analysis

using customer specific

data

• Customer and product

specific handling and

operational procedures

• Implementation teams

globally, using one

standard

• Automated SOP change

management & version

control

• Contingency planning as

part of SOP program

DHL Air Thermonet

Your Benefits

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40[insert_title] [insert_location] [insert_date]

DHL Air and Ocean Thermonet

With DHL Air Thermonet & DHL Ocean Thermonet, we offer the best service for

our LS&H customer in Air and Ocean transportation based on 5 key pillars:

NetworkQuality &

Compliance

Cold Chain

Design &

ImplementationIT Platform

Visibility &

Monitoring

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THANK YOU