Basics Serialization and Product Tracking in the Pharmaceutical Industry

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

2. The issue A counterfeit manufacturing lab in Columbia A counterfeit manufacturing lab in China

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 ConceptsComplexity significantly increases towards Product Tracking (including building hierarchy / aggregation)

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. 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

7. 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

8. Proposal CMO Business Process mapping Pre-Analysis WorkshopResults CMO with ESO-customer 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 + CMO SPT-Training for users

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

10. Quality Assurance

11. High level IT-Architecture model

12. Potential solution on Packaging lines

13. 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 Aggregation e.g. Ukraine Serialization