The Changing Face of Pharma Supply Chain - IMAPAC · © 2016 Zuellig Pharma. All rights reserved....

Company Overview |

© 2016 Zuellig Pharma. All rights reserved. Confidential.

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ZUELLIG PHARMA

COMPANY OVERVIEW

ZUELLIG PHARMA OVERVIEW PRESENTATION


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The Changing Face of

Pharma Supply Chain a

Presented by

Brett Marshall Corporate Head, QA


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Introduction

Changing Pharma Portfolios & the Supply Chain

Regulatory Impact on Supply Chain

Q&A

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4

Company Overview |


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10,000

employees

Established in

1922

13 countries in Asia

Privately

owned

Leading Healthcare

Services Provider in

Asia

Company Overview |


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Purpose That Guides Us

in Every Market

Company Overview |


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Integrated Expertise Connects Healthcare

Companies to Patients & Consumers


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Global Pharma Growth @ 4-5% to 2020;

Dramatic growth of high cost biologics & specialty drugs @ 41% to 2020:

Cold Chain @ 65% growth

Non-Cold Chain @ 34% growth

In Asia (China, HK, VN, KO) drives double-digit industry growth

Logistics Spend @ $78.8B in 2016 to $93.8B in 2020;

Cold Chain: $12.6B in 2016 to $16.7B in 2020

• Traditional: Vaccines, Insulin, Blood Products, Oncology, etc

• New Drivers: Biotech & CTM

Non-Cold Chain: $66.2B in 2016 to $77.1B in 2020

The Pharma Supply Chain

Evolution of Drug Portfolios

Data source: http://pharmaceuticalcommerce.com/special-report/advancing-biopharma-cold-chain/


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Primary Objective:

Patient Safety through Sustained Product Integrity

Focus Areas

Label Specifications for Storage & Handling

Definition of Storage Expanded to Include Transport

Emphasis on Risk-Based Management Approach

Qualification/Validation of Facilities, Systems, Processes

Temperature Monitoring

The Pharma Supply Chain Global Regulatory Change


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Impacts End-to-end Distribution Solutions Across

All Markets

WAREHOUSING

PICK & PACK

DELIVERY

REDRESSING

Non-cold chain $3.4B

Cold chain $5.1B 1

Non-cold chain $61.1B

Cold chain $9.1B 1

Customer & Patient

Delivery Branch networks

1 http://pharmaceuticalcommerce.com/special-report/advancing-biopharma-cold-chain/


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Increasingly

Sophisticated Cold

Chain Facilities

Cold Room Storage by Market

Processes & facilities aligned to

highest industry standards &

requirements

(# Pallets, % total)

[VALUE], 24%

[VALUE], 18%

[VALUE], 15%

[VALUE], 13%

[VALUE], 11%

[VALUE], 10%

[VALUE], 4%

[VALUE], 2%

[VALUE], 2%

[VALUE], 1%

TH

KR

PH

MY

TW

ID

VN

HK/MO

SG

OTHERS

0 1,000 2,000 3,000

Ma

rke

ts


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Innovative Temperature Management Solutions

PACKAGING

MONITORING

INFRASTRUCTURE

eZCooler extends

holding time from 2

days with a traditional

system to 5 days

Sophisticated

temperature

monitoring systems

track temperature

before & during

transit & on arrival

Investment in thermal

isolation systems/solar

technology

QUALIFICATION & VALIDATION

Facilities, Systems, Processes,

Suppliers, DQ, IQ, OQ, PQ

Master Validation Plans

Validation Protocols & Reports

Company Overview |


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EzCooler: Proven Cold Chain Transport Technology

Extends Product Holding Time From 2 to 5 Days

100% recyclable, using safe,

non-toxic materials

Phase Change Material

(PCM) specifically formulated

for different temperature

needs

Reusable Thermal Cases

utilising unique thermal

isolation chamber system

Easy pack-out system

reduces pack-out time


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Regulatory Governance a Plethora of Global Standards

to a Standardized & Workable GSDP Framework

EU GDP of Medicinal

Products for Human Use

Guideline (EU GDP), 24

November 2013

Parenteral Drug Authority

Technical Report 39:

Guidance for Temperature-

controlled Medicinal

Products, 2007

<1079> Good Storage and

Shipping Practices.

USP36/ NF 30 supplement,

March 2012

Model Guidance: Storage &

Transport of Time

&Temperature-sensitive

Pharmaceutical Products.

Annex 9, WHO TRS No. 961,

2011

U.S. Code of Federal

Regulations, CFR 211.142

and 211.150: Storage and

Distribution

Guidelines for Temperature

Control of Drug Products during

Storage and Transportation (Gui-

0069). Health Canada Health

Products and Food Branch

Inspectorate, 2011

US Pharmacopeia USP29

NF24 Page 2994 Volume

No 29(5) Page 1625

PIC/S Guide to Good

Distribution Practice for

Medicinal Products PE011-

1, 01 June 2014

American Society for

Testing and Materials,

(ASTM) 2011

ISO

9001:2015

ISO 13485:

2016

Guidance on Wholesale

Distribution Practice. Medicines &

Healthcare Products Regulatory

Agency (MHRA) Rules &

Guidance for Pharmaceutical

Manufacturers and Distributors,

2007


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Iata’s CEIV Certification for Pharma Logistics

Tackles the Compliance Challenge for the Airline

Industry

Freight

Forwarders Trucking

Companies Distributors

Airlines Ground

Handlers Airports


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CEIV Pharma Establishes A Standard Behaviour

Across Industry Players


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Future Trends

Expansion of Temperature Controlled Storage & Delivery

Investment in Infrastructure, Systems & Processes - & Compliance

Expansion of Detail in Implementing Guidelines of Regulation, &

Expanded Compliance Monitoring by Regulators

Risk-based Approach to Supply Chain Complexity

Company Overview |


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ZUELLIG PHARMA

COMPANY OVERVIEW


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Thank You!

The Changing Face of Pharma Supply Chain - IMAPAC · © 2016 Zuellig Pharma. All rights reserved....

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