Basics Serialization and Product Tracking in the
Pharmaceutical Industry
April 2016
The issue
A counterfeit manufacturing lab in Columbia
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A counterfeit manufacturing lab in China
What is the aim of a typical Serialization and Product
Tracking project in the pharmaceutical industry?
• The aim is to implement technical measures to raise the barrier
against counterfeit products, thus enhancing the security of the
pharmaceutical supply chain in compliance with individual country
regulations already in place
• Current understanding is that the average packaging network of a
pharmaceutical manufacturer or contract manufacturing organization
does not have fully implemented this technical capability
• Developing a clear strategy to mitigate the risks of any future
serialization regulation in order to ensure quality of the product and to
reduce overall project implementation and operational cost
• Starting with a first impact analysis including the review of the
regulations landscape and it’s impact on processes, packacking
equipment and IT-systems
Product Coding Concepts
Complexity significantly increases towards Product Tracking (including
building hierarchy / aggregation)
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High level impact of the implementation of Serialization and
Product Tracking (SPT) in the pharmaceutical supply chain
• Packaging lines in the manufacturing sites have to be revised and
upgraded and newly validated for new required equipment like
barcode/datamatrix printers and inspection cameras able to cope
with the regulatory requirements.
• Standalone rework and aggregation tables are necessary in own site
production packaging and warehouse in order to deaggregate,
rework and rebuild the packaging hierarchy for small quantities to be
reworked
• To manage the serialized data properly all of this equipment needs to
be connected with a LMS for the packaging operations and the
warehouse (Line Management System)
• A smart serialnumber-management process has to be implemented
in close alignment within the partner network of the contract
manufacturing organizations
High level impact of the implementation of Serialization and
Product Tracking (SPT) in the pharmaceutical supply chain
• Depending on individual country legislation, serialized and
aggregated data of the product, it’s packaging hierarchy of the levels
item, bundle, case and pallet and their relationship to each other as
well as the detailed shipment information have to be tracked and
traced in a new SPT-IT-System
• A deep process re-design is required in order to implement the new
To-Be processes across the organization. The whole SOP-structure
of the pharmaceutical company needs to be thoroughly analyzed and
impacted SOPs to be updated respectively newly written.
• Intensive Enduser-Training has to take place across the organization
before Go-Live
Process - Recommendation
• First step: SPT business process mapping & Impact
assessment
• Second step: Define To-Be process for Serial number request,
Packaging Line Operations and Quality assurance
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Proposal CMO Business Process mapping
Pre-Analysis
CMO with ESO-customer
Workshop Results
End to end «To Be» Process-flows
specific to SPT
Concept paper, Business Scenarios,
List of SOP
Create SPT parent SOP
Update SOPs of functional
groups
SPT-Training for users
CMO
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+
Line Operations
New serialization process and automatic/manual aggregating or deaggregating a
packaging hierarchy need to be understood, trained and performed.
Subprocess
Impact
Impact description
Next steps
•
•
•
•
•
Equipment
Setup
Changeover
Samples
Deviations
management
Integration with
serialization process,
no impact on the
process itself
No process impacts due to serialization
New SOP’s for the new
equipment
In-process line
readings
Low Impact
New challenges of vision cameras to be
implemented
To be reflected in SOP
In Process
Rework
Low Impact
All reject bins need to be defined for how to
process the rejected item
To be reflected in SOP
No impact
With regards to SPT yield has to be
calculated after printing on primary
product container (bottle or carton)
To be reflected in SOP
Yield calculation
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Quality Assurance
Subprocess
Impact
Impact description
Next steps
•
•
•
•
•
•
Integration
with
serialization
process, no
impact on the
process itself
Serialization requires a higher integration with those
subprocesses which should be reflected in the SOP
structure. For example:
•Deviation process remains the same. An unplanned
event at a vision camera will be treated like any other
unplanned event.
•Reconciliation for the label room remains the same
To be reflected into SOP
management and structure
Batch record review
Medium
Impact
Reconciliation of serialization process requires a new
report for batch record review. Commissioned items of
Serialization System must equal closeout quantity in
Shopfloor System
Does your Serialization System equal your Shopfloor
System?
To be reflected into SOP
management and structure
Batch release
Medium
Impact
Reconciliation of serialization process requires a new
report for batch release. Commissioned items of the
Serialization System must equal stock quantity in
warehouse system
To be reflected into SOP
management and structure
Sampling
Deviations
Investigation
Inspection
Stability
Label control
Patient Complaints
To be reviewed in a second workshop
Recalls
To be reviewed in a second workshop
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High level IT-Architecture model
Potential solution on Packaging lines
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An example:
Packaging line configuration and gateway to EU medicine
verification system (EMVS)
Blistering
SAP AII: Auto ID Infrastructure
MLS: Site server connecting
multiple packaging lines
System
Serialization
Aggregation e.g. Ukraine