improving gdp compliance through collaboration€¦ · andrew lester (lhr) healthcare manager north...

Improving GDP Compliance Through Collaboration

FOUNDED 1979

GLOBAL HEADQUARTERS Seattle, Washington

REGIONAL HEADQUARTERS London, Dubai, Singapore & Shanghai

PEOPLE Over 15,300 Employees Worldwide

2015 REVENUE $6.6 Billion

Traded on NASDAQ

Fortune 500, S&P 500

HIGHLIGHTS

June 10, 2016 Property of Expeditors International of Washington, Inc. and its subsidiaries. Reproduction by written authorization only. ©

EUROPE

INDUSTRIES WE SERVE

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Property of Expeditors International of Washington, Inc. and its subsidiaries. Reproduction by written authorization only. 2015 ©

EUROPE GDP FACILITIES

Expeditors has invested in strategic GDP facilities throughout our network which are GDP Compliant to the highest EU standards and utilise a universal Quality Management System.

• Strategic Facility completed

• Additional facility completed

• Additional facility in progress

• Potential GDP requirement 2016

GDP STRATEGY


• Previous transport rules and guidance only covered Wholesale Distribution

• Domestic agencies largely focussed within their borders

• Globalisation not really considered

• Change to patent laws gave rise to a whole new generics supply chain

• GMP is only part of the chain

• International transport not really identified as a major risk

THE ORANGE BOOK AND BEYOND

GDP IS JUST WAREHOUSING, ISN’T IT?


UNIVERSAL STANDARD

• Clear instruction from

the MHRA/HPRA

• Recognised as among

the highest standards

• MHRA and HPRA

licencing tests the process

WHO IS SETTING THE STANDARD IN GOOD DISTRIBUTION PRACTICE?

CHOSEN BENCHMARK

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FIND THE RIGHT PEOPLE

GLOBAL TEAM

Global Director

Andrew Lester (LHR)

Healthcare Manager North

America Pat Luisi (EWR)

Nortam GDP Compliance

Manager Jean-Claude Cardinal (YUL)

Healthcare Manager Europe

Andy Faes (BRU)

Healthcare Manager EU 2

Marrie Groeneveld (DUS)

Healthcare Manager EU 1

Radek Samsonowicz (LHR)

EU GDP Compliance

Manager Derek Brown (LHR)

Healthcare Manager MAIR

Roland Hankache (BEY)

Healthcare Manager Asia

Victor Yong (SIN)

Asia GDP Compliance

Manager TBA


A SHED IS JUST A SHED……………

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QUALITY MANAGEMENT IS THE KEY

TWO MAIN COMPONENTS

• GDP Quality Management System

• GDP Air Cross Dock Facilities • GDP Compliant Facilities/Operations

• Temperature Controlled Storage

Both are essential to the success of the model


GLOBALLY CONSISTENT

FACILITY REQUIREMENTS LISTING

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• Convert existing facilities • Expensive

• Not built for purpose

• Inefficient

• Can interfere with existing operations

• New build

• Even more expensive

• Designed to suit

• Dedicated third party

• Shared third party

UNDERSTANDING THE LOCAL MARKET

A VARIABLE MODEL

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21 CFR 11

SYSTEMS VALIDATION

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Expeditors must maintain a secure IT infrastructure to keep our information and our customers' information safe and secure from outside interference and a clear continuity and disaster recovery plan. Expeditors' system development and systems acquisition lifecycles (SDLC and SALC) govern the development and operations of our internally developed and purchased systems. The SDLC and SALC are designed, written and maintained in compliance with the controls specified in CFR 21 Part 11 and GxP.


GDP QMS has been published and is operating in all locations

• Approved by external audit

• Approved by customer audit

• Based upon Expeditors Quality Programme

• Covers Expeditors operations and management of third parties

• Basis of GDP for any branch

• Just add temperature controlled storage!

GLOBALLY CONSISTENT

GDP QUALITY MANAGEMENT SYSTEM

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THE BASICS

TRAINING PROGRAMME

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FOR THE SPECIALISTS

TRAINING PROGRAMME

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Don’t Drop The Baton

Collaborating With All Parties Involved


THE TRADITIONAL DANGERS TEMPERATURE EXCURSIONS


THE MAIN PLAYERS

WISH LIST

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• Origin Handling • GDP Compliant

• Temperature Controlled

• Airside if possible or close to the airport

• Airline • Access plane side if possible

• First on the aircraft

• Controlled environment on the aircraft

• Destination Handling

• First off the aircraft if possible

• Express release to forwarder

• GDP compliant Temperature controlled storage at destination

The Right Start

Prepare to Succeed


ORIGIN HANDLING PARTNER

Situation • Dedicated TC air service handling Agent

- Capacity available

• Active temperature control management - Physical warehouse environment only

• Temperature Control qualification needed - Guidance provided on the process and required standards for

mapping and recording

• GDP compliance standards to be built - SOP suite template provided

• Minimal GDP training - Expeditors provided compliant training

TC NOT GDP


ORIGIN FACILITY OVERVIEW


TRANSATLANTIC HEALTHCARE SERVICE ORIGIN

Features • Fully GDP authorized and licensed facility and procedures

• +2˚C to +8˚C and +15˚C to +25˚C handling and storage capacity

• Temperature mapped and monitored facility

• Full passive and active packaging capability

• All freight is thermal blanket wrapped for added protection prior to departing facility

• Operating hours: 24/7/365

• ULD’s are built by Expeditors trained staff

• On tarmac handling in Expeditors dedicated Pharma Hub

• Direct access from Pharma Hub to aircraft plane side within minutes

• Late cut-off and last loading on aircraft

Pass The Baton Safely

GHA to Airline


CONSOLIDATED AND PROTECTED FREIGHT HELD IN GDP COMPLIANT CONDITIONS

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FREIGHT TAKEN DIRECT TO AIRCRAFT NOT STAGED IN AIRPORT WAREHOUSE

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ON THE AIRCRAFT

Features

In Flight

• Contracted daily space allocation

• GDP SOP devbeloped

• Direct origin to destination flights

• Temperature controlled cargo hold

• Specific quality control requirements

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The Final Leg

GDP Storage at Destination


DESTINATION PARTNER

• Within 5kms of the airport

• US Customs bonded facility

• Temperature controlled but not mapped to GDP standards

• Support needed to develop GDP SOPs

• Support needed to train warehouse staff and drivers

• SLA needed to confirm GDP requirements and investments

• GDP audits to confirm compliance

• CAPAs raised and closed out prior to service commencing

TC NOT GDP


Destination

• First off and express handover at destination

• Immediate transfer via validated reefer truck to GDP compliant facility

• ULD’s are broken down by Expeditors trained staff

• +2˚C to +8˚C and +15˚C to +25˚C handling and storage capacity

• Temperature mapped and monitored facility

• Full passive and active packaging capability

DESTINATION HANDLING

Getting to the Finish Line


INDEPENDENT APPROVAL

2015 Property of Expeditors International of Washington, Inc. and its subsidiaries. Reproduction by written authorization only. ©

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improving gdp compliance through collaboration€¦ · andrew lester (lhr) healthcare manager north...

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