1. Basics Serialization and Product Tracking in the Pharmaceutical Industry April 2016

2. The issue A counterfeit manufacturing lab in ColumbiaA counterfeit manufacturing lab in China 06.06.2016

3. 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

4. Product Coding Concepts Complexity significantly increases towards Product Tracking (including building hierarchy / aggregation) 06.06.2016

5. 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

6. 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 High level impact of the implementation of Serialization and Product Tracking (SPT) in the pharmaceutical supply chain

7. First step: SPT business process mapping & Impact assessment Second step: Define To-Be process for Serial number request, Packaging Line Operations and Quality assurance Process - Recommendation 06.06.2016

8. Proposal CMO Business Process mapping End to end «To Be» Process-flows specific to SPT Update SOPs of functional groups Concept paper, Business Scenarios, List of SOP Pre-Analysis Workshop Results Create SPT parent SOP CMO with ESO-customer + SPT-Training for users CMO 06.06.2016

9. Line Operations SubprocessImpact Impact descriptionNext steps Equipment Setup Changeover Samples Deviations management Integration with serialization process, no impact on the process itself No process impacts due to serializationNew 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 Yield calculationNo impactWith regards to SPT yield has to be calculated after printing on primary product container (bottle or carton) To be reflected in SOP New serialization process and automatic/manual aggregating or deaggregating a packaging hierarchy need to be understood, trained and performed. 06.06.2016

10. Quality Assurance SubprocessImpact Impact descriptionNext steps Sampling Deviations Investigation Inspection Stability Label control 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 reviewMedium 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 releaseMedium 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 Patient ComplaintsTo be reviewed in a second workshop RecallsTo be reviewed in a second workshop 06.06.2016

11. High level IT-Architecture model

12. Potential solution on Packaging lines 06.06.2016

13. An example: Packaging line configuration and gateway to EU medicine verification system (EMVS) Blistering Serialization Aggregation e.g. Ukraine System SAP AII: Auto ID Infrastructure MLS: Site server connecting multiple packaging lines