Cold Chain Solutions!
Vaccines and Hospitals and
Clinical Trials! Pharmaceutical!
Blood!
Peter Norton!
• Business Development Director at DeltaTrak Inc.!
• Expertise: Cold Chain and Supply Chain Logistics Solutions!
• Previously an Associate Director and Program Manager at
Genzyme Corporation in Materials Management group.!
• Previously worked at GSK in consumer health division’s IT
operation – technology solutions and QA audits.!
• Technology Degree from the UK, BA in Business, plus IT
Credits from Capella University, (program sponsored through
GSK)!
Cold Chain Risk Aversion Planning!
A Renewed Focus !
Peter D. Norton
Director of Business Development!
Regulations, Guidelines and Risk!
Welcome to the DeltaTrak webinar focused on Compliance and Risk,
within the Life Sciences industry.!
!
Agenda:!
1. Take a quick look at two recently introduced regulations within the EU and China!
2. How Risk is now becoming a big factor in any quality control program!
3. A review of common areas to look at in Risk Assessment and Aversion planning.!
4. How to establish a Risk Aversion, or Mitigation Plan!
5. Specifics on how this relates to Cold Chain i.e. Management versus Monitoring
your Cold Chain!
6. Summary of what we covered and Take Away’s!
7. Question time!
4! Confidential!
The Cold Chain Today – Recent Changes!
New Regulations – EU and China:! ü Supply chain risk aversion planning –
Ø In March of 2013 the EU released new documented!
guidelines for GDP:! ü Environmental controls for cold chain
ü (EU -Guidelines of 7 March 2013 on products, like vaccines, and Bio-Logics!
Good Distribution Practice of Medicinal
ü Selection of Staff and on-going Staff
Products for Human Use – 2013/C
Training!
68/01) – Implementation period; 6
months after 8th March 2013! ü Warehouse and Storage condition
Management!
Ø In June of 2013 the Chinese FDA
ü Environmental condition management
implemented their new guidelines. !
of products during transportation –
ü (China SFDA – Good Supply Practices “source to patient”!
guidance – Introduced on June 1, 2013)
– Implementation Period: 3 years! ü Controls to prevent falsified medicines
from entering the supply chain!
Ø Both of these new regulations are very
ü A fully documented Risk Mitigation plan
similar in content and share as part of the Quality Management
recommendations for controlling and System!
managing the supply chain:!
5! Confidential!
The Cold Chain Today – Recent Changes!
A common theme – Harmonization Globally:!
Ø Requirement for a fully document Risk Mitigation plan as part
of the Quality Management System!
What has changed?!
Ø Existing regulations have been updated to include new
detailed requirements around identifying risk and security.!
Ø New regulations have renewed focus on overarching quality
regulations related to risk, falsified medicines, and audits.!
So - Two new, or enhanced areas:!
Ø Renewed Emphasis on Security related to anti-counterfeiting
and falsified medicines!
Ø e.g. HR3204 DQSA in USA Nov’ 2013!
Ø Renewed Focus on total Supply Chain Risk Aversion and
Mitigation Planning!
6! Confidential!
What are the Potential Risk Basics?!
Let’s look at Risk
Assessment.!
Where do you start?!
Supply Chain is Complex!!
However, risk in the supply
chain can generally be broken
down into 5 key areas:!
1. Internal Risks !
2. Network Risks !
3. Industrial Risks !
4. Environmental Risks !
5. Compliance Risks!
7! Confidential!
The Cold Chain Today!
Common Risks in Cold Chain Logistics:!
In any cold chain shipping and logistics routes or processes there are usually a number
of common elements, or items that will exist. These could include:!
Ø The cartons that are being used!
Ø The carriers I am using – road, sea or air, and how many hand-offs and
human elements!
Ø The time of year and/or location in the world where the products are going to
be shipped to!
Ø Size and quantity!
Ø What kind of condition monitoring is being employed – e.g. USB, Chemical,
RFID, etc!
Ø Data collection and storage procedures!
Don’t forget the “Cloud”!!!!!
8! Confidential!
The Cold Chain Today!
Risk Assessment – Identifying The Risks!!
Where should I start?!
Number 1 - From Past Experience.!
Focus attention to where potential risk generating events are commonly encountered!
These include for a short list:!
Ø Any point where this is human intervention!
Ø Any point where there is a product handoff point!
Ø When you are shipping high-value items on a new route!
Ø Country to country transfers!
Ø Outsourced Data storage!
Ø When you can’t see what is happening inside the carton prior to receipt at the end
point!
9! Confidential!
The Cold Chain Today!
Risk Mitigation – Making Plans!
What should be included?!
Ø Review and audit your supply chain to assess where risk
does, or may exist!
Ø Assess what the impact of these may be and create a list
with the highest probability items at the top to address first!
Ø Define your risk mitigation strategies for the highest level
items and work down the list from High to Low!
Ø Implement the strategies and document them!
10! Confidential!
The Cold Chain Today!
Risk Mitigation Plan’s Effectiveness – How Should I Check?!
How should you check for Compliance and Effectiveness?!
Ø Monitor the supply chain and audit any intermediate partners, or
vendors on a regular basis!
Ø “Look-out for Murphy!”!
Ø Get QA to conduct their own audit processes, throughout the supply
chain and warehouses!
Ø Maintain good documentation and audit records!
Ø Visit your vendors and suppliers – perform external on site audits, also a
security audit on your “Cloud Services” provider!
Ø Maintain good documentation and audit records!
Ø Maintain good performance records and make changes as necessary!
Ø Create a visibility path to the executive level “sponsors”!
But – What about Managing and Monitoring what goes on inside the
carton?!
11! Confidential!
What about temperature monitoring?!
Cold Chain – Management versus Monitoring!
It is important to note that both these new guidelines/regulations, as well as many
existing ones, require monitoring of the supply chain from “Source to Patient”:!
Ø This includes, manufacturing (GMP), Distribution, Warehousing, Transportation,
Local Storage and at Patient distribution point (GSP & GDP)!
Ø Monitoring is in many ways – Forensic !
Ø Use of go/no go devices and you only know at the end what happened!
Ø Management is having procedures and devices for Real Time Monitoring and a
solution that allows intervention if problems are encountered – e.g. Temperature
Excursions!
Ø Vaccines in a local storage refrigerator with a device that provides alarm alerts if
problems occur!
Ø A monitoring device/system that allows a “look” inside the carton to get a real time view!
Ø An RFID, or WiFi/Cellular system that monitors a warehouse environment and provides
real time alerts if, or when, problems occur!
A point to Note: It is estimated that about 15% of all Cold Chain shipments do
not have a monitoring device included with them – this is a Big Risk Area!
12! Confidential!
Summary!
Ø There will always be Risk in your supply chain !
Ø Even though your Risk Management plan includes good SOP’s and WI’s
make sure that people are adequately trained in these disciplines!
Ø Conduct self audits regularly!
Ø The cost of a Cold Chain Monitoring device or solution, is far less expensive
than the cost of disposal of a temperature compromised shipment!
Ø All Quality Systems and Risk Aversion Plans should have one over-arching
goal !
Ø Patient Safety coupled with Drug Efficacy!
Ø Final Point:!
Ø Do watch out for Murphy!!
13! Confidential!
End!
Thank You for your attention!
Questions? !!
!
Peter D. Norton!
Director of Business Development!
+1 978-302-3472!
pnorton@[Link]!
Web Site: [Link]!
Blog URL: [Link]
!
!
14! Confidential!
