Basics Serialization and Product Tracking in the Pharmaceutical

Basics Serialization and Product Tracking in the Pharmaceutical Industry April 2016

The issue A counterfeit manufacturing lab in Columbia 9/5/2021 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) 9/5/2021

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 9/5/2021

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 9/5/2021 +

Line Operations New serialization process and automatic/manual aggregating or deaggregating a packaging hierarchy need to be understood, trained and performed. Subprocess 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 9/5/2021

Quality Assurance Subprocess 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 9/5/2021

High level IT-Architecture model

Potential solution on Packaging lines 9/5/2021

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