1. UPS – GDP - CEIV
September 21st, 2016
HPCLC

2. Healthcare Compliance at UPS
UPS Healthcare Introduction
UPS and Regulatory Compliance
GDP
CEIV

3. Building the logistics of healthcare at UPS
UPS acquires Livingston
Healthcare Services
UPS opens healthcare campus in Burlington, ON
Healthcare Strategy develops Temperature True
UPS opens healthcare distribution facility in Roermond, the Netherlands
UPS acquires Pieffe in Italy
UPS acquires CEMELOG in Hungary
UPS opens UPS Packaging Center in Venlo, NL
Select Healthcare Milestones
UPS opens healthcare distribution campus global air hub
UPS opens healthcare distribution facility in Puerto Rico
UPS opens healthcare distribution in Asia
UPS expands suite of shipping solutions for healthcare customers, including UPS Proactive Response®
UPS acquires Polar Speed in the UK and Poltraf in Poland
UPS started our focus on the Healthcare sector in 2000 with the acquisition of a Canadian company called Livingston. Overall it has been a long 14 year journey in expanding our HC Compliant footprint, adding Healthcare expertise, and adding capabilities especially around temperature sensitive shipping.
But our story in Europe has been a bit different. For us here it started in 2010, only 4 short years ago…and it has been an intense 4 years for some of us.
From 1 (40K sm) Healthcare compliant facilities to 14 (>130k sm)
Through organic efforts and through the acquisition of 3 great companies that have local knowledge and a strong culture.
Launched UPS Temperature True – containing Temperature sensitive AF and Ocean freight services (including the innovative PP360 Active container)
Launched Proactive Response – A proactive monitoring and intervention service for HV and Thermal passive systems
Created Healthcare dedicated sales and solutions teams – to understand requirements better
We have expanded our capabilities in Europe to move Biologics and dry ice to 11 new countries in Europe now serving 50 countries
And although we are proud of these accomplishments we know we have more to do, customers have told us so;
Need to better align our strengths with customer needs to maximize value
Need to be more flexible during solution development
And we take these seriously…and will continue to listen and focus on delivering value..
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4. Healthcare Services Overview
Our specialized distribution, customer care and transport solutions allow you to maximize supply chain efficiency, meet regulatory requirements and protect your products from temperature excursions.
Warehousing
49 global locations
Over 6 million sqft
GDP & GMP licences
Temperature control
Inventory management
Labelling and kitting
Order to cash services
Product verification
Small Package
• In-Room Delivery
• UPS Proactive Response
• UPR Secure
• Temperature loggers
• Signed Document Return
• Temperature Sensitive Packaging
• Preferred Customer Associate Program
Returns Portfolio
Freight Forwarding
UPS Temperature True
Quality assurance
Temperature loggers
Temp. Sens. Packaging (active/ passive cont.)
Proof of performance reporting
Cooling and re-icing
Contingency planning
Network of control towers

5. Healthcare Compliance at UPS
UPS Healthcare Introduction
UPS and Regulatory Compliance
GDP
CEIV

6. UPS & Regulatory compliance
Robust Healthcare Quality System for 3PL and Temperature True, implemented globally
Continually monitors the evolving healthcare regulatory environment for impact on UPS as a 3PL and a transportation provider
Collaborating with healthcare clients, anticipating changing needs and expectations
Evolving regulations and their interpretation continue to challenge UPS, Pharma Shippers and the industry

7. Healthcare Compliance at UPS
UPS Healthcare Introduction
UPS and Regulatory Compliance
GDP
CEIV

8. Good Distribution Practices (GDP) is one of GxP
The purpose of the EU Good Distribution Practices (GDP) is to ensure control over the distribution chain to maintain the quality and integrity of the distributed medicinal products.

9. Healthcare Compliance Culture
GDP
Healthcare Compliance Culture
People
Process
Premises
Proof
Quality System
Training People
Clear and Specific operating procedures and quality system SOPs
Ensuring our facilities meet a standard – sanitation and pest control, segregation, special handling and processing areas, temperature monitoring and control as required
Evidence to support all the activities (documentation, self assessments, quality agreements, contracts, qualified vendors etc.)

10. GDP Compliant Space Active container charging area
Container handling system
Temperature control monitor
Temperature registration system

11. GDP
UPS provides multiple modes of transportation for the Healthcare industry
In 2007 UPS Healthcare Strategy launches a Healthcare exclusive forwarding product – UPS Temperature True
Healthcare Compliance oversight established
Dedicated team devises, implements and governs the UPS Temperature True Quality System
This team supports all UPS transportation products on Healthcare Compliance matters
How best to or should UPS pursue GDP certification?

12. Healthcare Compliance at UPS
UPS Healthcare Introduction
UPS and Regulatory Compliance
GDP
CEIV

13. CEIV
Challenges
For providers with formalized systems in place, is a validation warranted
Clients aren’t demanding a certification
How widely will the validation be accepted
Will possession of the certification displace client audits
Scalability
For providers with multiple locations – may struggle with cost / benefit or ROI
Cost of maintaining the certification
Benefits
Based on GDP, IATA and Pharmaceutical engagement
Rigorous program
Aligns stakeholders in the supply chain
Defines a consistent standard that can be duplicated globally
Provides the model for supply chain partners that do not have a formalized program
Existing programs are improved or validated
Provides confidence for the healthcare industry that is looking for leadership in transportation