Company Overview |
© 2016 Zuellig Pharma. All rights reserved. Confidential.
1
ZUELLIG PHARMA
COMPANY OVERVIEW
ZUELLIG PHARMA OVERVIEW PRESENTATION
© 2016 Zuellig Pharma. All rights reserved. Confidential.
1
The Changing Face of
Pharma Supply Chain a
Presented by
Brett Marshall Corporate Head, QA
© 2016 Zuellig Pharma. All rights reserved. Confidential.
2
Introduction
Changing Pharma Portfolios & the Supply Chain
Regulatory Impact on Supply Chain
Q&A
1
2
3
4
Company Overview |
© 2016 Zuellig Pharma. All rights reserved. Confidential.
3
10,000
employees
Established in
1922
13 countries in Asia
Privately
owned
Leading Healthcare
Services Provider in
Asia
Company Overview |
© 2016 Zuellig Pharma. All rights reserved. Confidential.
4
Purpose That Guides Us
in Every Market
Company Overview |
© 2016 Zuellig Pharma. All rights reserved. Confidential.
5
Integrated Expertise Connects Healthcare
Companies to Patients & Consumers
© 2016 Zuellig Pharma. All rights reserved. Confidential.
6
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/
© 2016 Zuellig Pharma. All rights reserved. Confidential.
7
7
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
© 2016 Zuellig Pharma. All rights reserved. Confidential.
8
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/
© 2016 Zuellig Pharma. All rights reserved. Confidential.
9
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
© 2016 Zuellig Pharma. All rights reserved. Confidential.
10
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 |
© 2016 Zuellig Pharma. All rights reserved. Confidential.
11
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
© 2016 Zuellig Pharma. All rights reserved. Confidential.
12
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
© 2016 Zuellig Pharma. All rights reserved. Confidential.
13
Iata’s CEIV Certification for Pharma Logistics
Tackles the Compliance Challenge for the Airline
Industry
Freight
Forwarders Trucking
Companies Distributors
Airlines Ground
Handlers Airports
© 2016 Zuellig Pharma. All rights reserved. Confidential.
14
CEIV Pharma Establishes A Standard Behaviour
Across Industry Players
© 2016 Zuellig Pharma. All rights reserved. Confidential.
15
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