Basics Serialization and Product Tracking

Basics Serialization and Product Tracking in the
Pharmaceutical Industry
April 2016
The issue
A counterfeit manufacturing lab in Columbia A counterfeit manufacturing lab in China
03.02.2020
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)
03.02.2020
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
03.02.2020
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
Update SOPs of functional

Create SPT parent SOP +
groups
CMO
03.02.2020
SPT-Training for users
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 Integration with No process impacts due to serialization New SOP’s for the new
• Setup serialization process, equipment
• Changeover no impact on the
• Samples process itself
• Deviations
management
In-process line Low Impact New challenges of vision cameras to be To be reflected in SOP
readings implemented
In Process Low Impact All reject bins need to be defined for how to To be reflected in SOP
Rework process the rejected item
Yield calculation No impact With regards to SPT yield has to be To be reflected in SOP
calculated after printing on primary
product container (bottle or carton)
03.02.2020
Quality Assurance
Subprocess Impact Impact description Next steps
• Sampling Integration Serialization requires a higher integration with those To be reflected into SOP
• Deviations with subprocesses which should be reflected in the SOP management and structure
• Investigation serialization structure. For example:
• Inspection process, no •Deviation process remains the same. An unplanned
• Stability impact on the event at a vision camera will be treated like any other
• Label control process itself unplanned event.
•Reconciliation for the label room remains the same
Batch record review Medium Reconciliation of serialization process requires a new To be reflected into SOP
Impact report for batch record review. Commissioned items of management and structure
Serialization System must equal closeout quantity in
Shopfloor System
Does your Serialization System equal your Shopfloor
System?
Batch release Medium Reconciliation of serialization process requires a new To be reflected into SOP
Impact report for batch release. Commissioned items of the management and structure
Serialization System must equal stock quantity in
warehouse system
Patient Complaints To be reviewed in a second workshop
Recalls To be reviewed in a second workshop
03.02.2020
High level IT-Architecture model
Potential solution on Packaging lines
03.02.2020
An example:
Packaging line configuration and gateway to EU medicine
verification system (EMVS)
Blistering
SAP AII: Auto ID Infrastructure

MLS: Site server connecting System
multiple packaging lines
Serialization Aggregation e.g. Ukraine

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Basics Serialization and Product Tracking in the

A counterfeit manufacturing lab in Columbia A counterfeit manufacturing lab in China

• The aim is to implement technical measures to raise the barrier

• Packaging lines in the manufacturing sites have to be revised and

• Depending on individual country legislation, serialized and

CMO with ESO-customer

End to end «To Be» Process-flows

Concept paper, Business Scenarios,

Update SOPs of functional

Subprocess Impact Impact description Next steps

Patient Complaints To be reviewed in a second workshop

Recalls To be reviewed in a second workshop

SAP AII: Auto ID Infrastructure

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