MANAGINGTEMPERATURE
EXCURSIONSKEY POINTERS
THAT MUST
BE ADDRESSEDIntroduction and overview

3What to do when a temperature excursion occurs

4Conclusion

52

Introduction and overview
The maintenance of cold chain product integrity
across the entire supply chain demands rigorous
processes and cold chain expertise of the highest
calibre—from packaging, handling, storage &distribution of temperature sensitive Investigational
Medicinal Products (IMP), all the way to the investigatorsite. These eBooks outline industry trends and reviews
how Fisher Clinical Services solutions are meetingthe challenges of the cold chain distribution of clinical
trial supplies all over the world.
COLD CHAIN INDUSTRY TRENDS provides an industry overview anda framework for discussion. The importance of a robust supply chain isaddressed. It includes planning recommendations for biopharmaceuticalcompanies preparing to scale up to global vaccine trials.
COLD CHAIN SHIPPING CONSIDERATIONS takes a deep dive into
passive shipping options and how they work, with information on
the advantages and disadvantages of various coolants.
EVALUATING & QUALIFYING TEMPERATURE MANAGED SHIPPERS
provides insight into how we qualify shipping options with a case study
example of a ‘return and reuse shipper pilot’ which delivered very
positive results.
MANAGING TEMPERATURE EXCURSIONS provides top tips on thebest course of action to take, and provides summary recommendationsfor Sponsors on how to handle cold chain or temperature sensitive
IMP across the supply chain, up until delivery to the investigator site.

3

What to do when a temperature excursion occurs
A temperature excursion occurs when clinical trial material is stored at a temperature outside of
the specified temperature range as defined on the label. This can have a substantial impact ona clinical trial study; it can impact the quality, efficacy and safety of products. More importantly,
an excursion can significantly impact patient safety if not detected and communicated effectively.

Here are a few pointers:
Notify the party who advised of the temperature
excursion to keep the material in a quarantined
status until a ‘fit’/‘not fit-for-use’ statement has beenobtained from the manufacturer. This instruction should
also be included as part of the paperwork that wassent to the investigator site at the point of dispatch by
the distributor

Advise the site if the drug is fit for use and ensure
the temperature reading is kept within the study folder
regardless of the outcome.

Ask the site to email a copy of the temperature
reading if they hadn’t already in their initialcorrespondence. Most temperature monitors allow
for the site to download the report directly onto theircomputer.

It is advisable to keep a record of any excursion
and supporting data—lot number or material specificnumbers—together with any other correspondence incase this information is needed again in the future, forexample during an audit.

Review the temperature excursion report and forward
the data to the drug manufacturer for drug disposition.
Make sure to receive back a written statement whichcontains information linking the ‘fit-for-use’ statementback to that particular shipment (i.e. the shipment or
waybill number).

Patient visits may need to be rescheduled until theeffected material is deemed fit for use, or the material
is resupplied by the pharmaceutical company. This may
take some time, leading to patient and site frustration,
as well as potential patient dropouts impacting theoverall success of the trial.

4Conclusion
Concluding recommendations for a Sponsor’s clinical supply chain for cold chain and temperature sensitive IMP:

1

2

3

Agree on a distribution strategy
In logistics, anything is possible,
but bear in mind that overcoming
challenges in an outsourcing projectrequires a partnership of supplierand sponsor.

Planning

4

Use qualified couriers withlocal expertise & global values
We have a global footprint of 27 cGMP
facilities with logistics experts within
its project management teams. It is
important for these logistics experts
to establish good working practices
with local couriers, encouraging
them to uphold the high standards oftransportation that are established bytheir global counterparts.

Define a range of shippers
based on a review of stability
data and destination
The Fisher Clinical Services teamuses rigorous testing, quality andperformance metrics in identifying andselecting shippers. A time period isselected to reflect every eventuality. Alldata is reviewed objectively.

5Pro-activity

Monitor and ensure safest
passage from hour 1 to delivery
Appropriate packaging and shipping
choices can spell the difference between
product that maintains integrity andproduct that requires costly replacement.
Last mile distribution is of paramountimportance. Why go to extensive effort
to ensure integrity of cold chain
supplies if the parties involved in thatlast mile of distribution do not upholddefined specifications? Liaise with theinvestigator site to support continued
cold chain conditions once clinicalsupplies are delivered to site.

6

Communicate clearlywith all parties
Clear communication enables supply
chain managers to do the best job
possible for sponsors, helping them tomeet their goals.

7Be flexible in yourprocesses and choices
Rely upon supply chain experts tomake recommendations and changes
as necessary to address issues as
they develop to ensure safe passage
of product to depots and clinicalsites. Allow the experts to do what
they do best.

Success

8Remember: Planning +Pro-activity = Success
Whenever possible, allow 6–12 months
for advance planning. The biggest
mistake made by sponsors in preparing
for vaccine/biologics trials is failing tobuild in sufficient planning time.

Balance risk, cost,compliance and timelines
First and foremost, remember thatthe safety of study subjects is theprimary concern for all clinical studies.

5

+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com© 2021 Thermo Fisher Scientific Inc. All rights reserved.
Published 09/21