This document discusses interfaces between Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP) standards in clinical trial material management. It provides an overview of key considerations for packaging, labeling, shipping initial supplies to sites, and using IRT/RTSM systems to optimize distribution and inventory management of investigational medicinal products (IMPs). The goal is to ensure adequate supply of the right drug reaches patients in a timely manner while avoiding waste. Simulation tools can help understand supply needs and test distribution strategies.

1. GMP Meets
GCP and GDP
Introduction to Basic IMP
Supply Management
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COURSE: MIND – MASTER IN DRUG DEVELOPMENT, UNIVERSITY OF COPENHAGEN
(QA, QC, GXP FOR PHARMACEUTICAL PRODUCTION). 2017
ANTONY PHAM (MSC)

2. Todays
Objectives
And Learning
Points
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3. Interfaces
Between GMP,
GCP and GDP
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4. GMP, GCP
and GDP
Interfaces
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5. CTS
MANAGEMENT
IS WORKING
WITH
MULTIPLE-
DISCIPLINES
IRT / RTSM VENDOR
Incl. CTMS administrators,
forecasting analyst etc.
DATA MANAGER AND
BIOSTAT
Incl. statistical
programmer
CMC and R&D PROJECT
MANAGER
Incl. Toxicologist (Phase 1
trials) and stability
scientist
CLINICAL TRIAL
MANAGER / CRAs
Incl. Field monitors and
site coordinators
PACKAGING CMO AND
CLINICAL CRO
Incl. third party depots,
courier companies and
various service providers
QA and Regulatory
Incl. Qualified person, QA
auditors
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6. OUR COMPANY
REDUCE TIMELINES AND COST AT THE SAME TIMEAND
AVOID DISRUPTION OF DRUG TO PATIENTS
“
WHAT ARE WE TRYING TO ACHIVE?
“
ENSURE THAT THERE IS ENOUGH DRUG AT SITE BUT
NOT TOO MUCH TO AVOID WASTE AND SHORTAGE AT
OTHER SITES
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7. Get The Right
Drug To The
Right Patient
In The Right
Time And
Condition…
CUSTOMER SERVICE
Maintain good
relationship with
investigator (and trial
manager)
STORAGE SPACE AT
SITE
And the size of the shipper
ENROLLMENT RATES
AND DYNAMICS
Changes in site status can
affect supply plans
SHIPPING LEADTIMES
From depot to depot and
depot to site and from site
to patient home
EXPIRATION AND
RETEST DATES
Resupply packaging lead-
times
STUDY DESIGN
Titration, weight, visit
windows, randomization
scheme
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8. CTS Project
Planning
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9. CTS Project
Start-Up
Guide
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10. LEAVE ROOM ON THE
LABELS FOR ADDITIONAL
LABEL (IF POSSIBLE)
- Useful when changing
use-by-date
USE LABELS SUITABLE
FOR THE INTENDED
TEMPERATURE RANGE
AND USE
- Freeze / Thaw; Twisting
bottle etc.
AVOID TO PACK
SCHEDULED DRUG IN THE
SAME DISPENSING KIT AS
UNSCHEDULED
- Limited space at site
USE COLOR AND
PICTOGRAMS
- Will enhance site and
patient compliance in
dosing
AVOID SINGLE PANEL
LABELS (IF POSSIBLE)
- Ensure the greatest
flexibility
BE CAREFUL FOR VARIED
RETEST DATES
- Potential un-blinding if
only replacing kits for a
single arm
SOME CONSIDERATIONS DURING
PACKAGING AND LABELING
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11. ENSURE THAT IMP KITS ARE
“SHIPPED” IN THE IRT / RTSM
• In order for the site to
acknowledge drug receipt
ENSURE THAT THE
TEAM IS READY
• QA is informed, to
quickly resolve any
temperature deviation
• Local CRA is informed
etc.
ASK FOR THE AWB NUMBER
• Track and Trace the shipment
• Check that the AWB number is
uploaded in systems
• Review/Check completed
shipment documents (incl.
invoices, certificate etc.)
ACTIVITIES TO KEEP IN MIND FOR
INITIAL SHIPMENT TO SITE
ENSURE THAT APPROVALS ARE IN
PLACE
• QP Cert.
• Submission of paperwork to custom
• Regulatory Green Light (EC and
approved submission)

12. STRATEGIES FOR WHEN
THE DRUG SUPPLY IS
LIMITED AND OR COSTLY
• Will help you optimize production and
distribution strategies
• Integrate with IRT / RTSM for real-
time updates
• Analyze supply impact due to change
in enrollment
• Test of “what-if” situations e.g.
adaptive study designs
USE A IRT / RTSM SYSTEM
• Avoid to ship out in blocks –
central randomization
• Product pooling – any kit may go
to any patient
• Predictive resupply – look ahead
on rand list and visit schedule
• Realtime patient and drug supply
tracking
SIMULATE / FORECAST SUPPLY“CLEVER” SUPPLY PLANS
• Ship only to sites when there is
patients – no frontloading
• And only the kits associated with
patient’s treatment group
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13. Distribution and
Site Inventory
Management
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14. Best Practices
for Clinical
Material
Distribution
Warehousing is a GMP
Operation
• Ensure that the CMO
procedures are well
documented and covers correct
material picking, and shipper
packaging and labelling
• Evaluate the type of shipper
and container used is suitable
for the IMP
• The right documentations is in
place for dangerous and
hazardous goods
• Avoid airports with challenging
customs and use a realiable
courier company
• Understand the classification of
the IMP and documentation
requirements
• Seek legal advice for setting the
right customs value 14

15. Introduction
to IRT / RTSM
System
• IRT / RTSM is a system that
randomize patients into
treatment groups and allocate
IMP kits
• Primary advantage of IRT / RTSM
systems is product pooling (IMP
kits and patients are not linked
until the time of dispensation)
• Control of site enrollment
• Real time IMP tracking
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16. IRT / RTSM
Management
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17. Adjust IRT /
RTSM
Shipment
Settings
According To
Study Phase
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18. Clinical Supply
Chain
Optimization
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19. Why is
Optimizing
the Supply
Chain so
Important?
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20. IMPLEMENT
SUPPLY
OPTIMIZATION
THROUGHOUT THE
ENTIRE PROCESS
OPTIMIZ-
ATION
FROM THE EARLY
1. PROTOCOL
DEVELOPMENT
AND DURING THE
2. PLANNING
PHASE
AND THROUGHOUT THE
3. TRIAL CONDUCT /
EXECUTION
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21. Drug Supply
Simulation Will
Help You
Understand:
• The required bulk drug amounts incl. overages
• When to manufacture and/or procure (API, IMP and
comparator drug)
• The right packaging strategy and optimal kit
configuration for the trial design (visit schedule,
randomization ratio etc.)
• The impact on drug supply due to variation in batch
sizes, expiry dates and changes in trial parameters.
• How to distribute the supplies to support the
enrolment and site inventory requirements.
• Implication on distribution costs and shipment
frequencies with the defined supply strategies (IRT
shipments strategies). 21

22. Metrics for
Clinical Trial
Supply
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23. Get in touch
Antony Pham / Founder
at SPLY ApS
ap@ct-sply.com /
+45 60 19 84 64
Frydenlundsvej 30, 2950
Vedbæk
Sply.dk
Q & A
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24. SPLY is a Danish clinical
trial supply consultancy
and technology
company working
closely with innovative
pharma and biotech
organizations.
We are developing
SIMPLY a forecasting and
simulation tool for
clinical trial supply and
logistics.
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