Impact of Serialization on Supply Chain

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1 Impact of Serialization on Supply Chain

2 Agenda Introduction What is serialization? Why required? Key developments international legislation and regulation Break Impact of serialization in supply chain processes SAP Solutions for serialization Lunch Project case Closure of the event Goldfish ICT Services BV External Serialization Seminar 25 March

3 Serialization framework Supply chain management Strategic intent Facility design GXP compliance Automation & IT Organizational change management Goldfish ICT Services BV External Serialization Seminar 25 March

4 Serialization framework Supply chain management Strategic intent Facility design GXP compliance Automation & IT Organizational change management Goldfish ICT Services BV External Serialization Seminar 25 March

5 Supply chain management Which products are produced in which plant and for which market? Within a plant; on which packaging lines are serial number relevant products produced? Which CMO s are capable handling serialization? Reduce impact by Shifting products to other lines? Shifting products to other sites? Shifting products to other CMO s? Goldfish ICT Services BV External Serialization Seminar 25 March

6 Supply chain complexity example Goldfish ICT Services BV External Serialization Seminar 25 March

7 Serialization data in a network What s your role in this network? Goldfish ICT Services BV External Serialization Seminar 25 March

8 Serialization framework Supply chain management Strategic intent Facility design GXP compliance Automation & IT Organizational change management Goldfish ICT Services BV External Serialization Seminar 25 March

9 Packaging line Adapting packaging lines / buying serialization units Importing number ranges for serial numbers Printing (2D) barcodes on single products and packaging Capturing serial numbers in packaging process Aggregation functionality Exporting packaging hierarchies Goldfish ICT Services BV External Serialization Seminar 25 March

10 Example packaging line Who is already investigating possibilities for packaging lines? Goldfish ICT Services BV External Serialization Seminar 25 March

11 Serialization framework Supply chain management Strategic intent Facility design GXP compliance Automation & IT Organizational change management Goldfish ICT Services BV External Serialization Seminar 25 March

12 Automation & IT systems Authorities Packaging line controller PI Serialization repository 3PL Interface tooling ERP CMO / CPO Goldfish ICT Services BV External Serialization Seminar 25 March

13 Automation & IT reporting Serial number reporting based on batch Ship to Report to Batch Batch Batch Batch Goldfish ICT Services BV External Serialization Seminar 25 March

14 Automation & IT reporting Serial number reporting based on delivery For whom is this a valid scenario? E.g. multi country packs Ship to Report to Batch Goldfish ICT Services BV External Serialization Seminar 25 March

15 Automation & IT - shipping Serial number capturing in delivery processing: Software for capturing serial numbers / shipping units during pick & pack process required What is the smallest unit of issue? Hardware for capturing serial numbers / shipping units: 1D scan engine vs 2D imager Goldfish ICT Services BV External Serialization Seminar 25 March

16 Automation & IT warehousing Physical inventory counting Scrapping Sampling Repacking Returns Goldfish ICT Services BV External Serialization Seminar 25 March

17 Automation & IT - Brand owner / CMO Serial number management (material/plant/cmo level) Interfacing (encrypted) serial number ranges to CMO s CMO Reports produced serial number data to: Brand owner(s) Directly to authorities Working with multiple CMO s/brand owners lead to maintaining many (different) interfaces When CMO ships to brand owner a sasn is desired Goldfish ICT Services BV External Serialization Seminar 25 March

18 Automation & IT - 3PL/DC When shipping to 3PL/DC a sasn is desired Goods receipt processing with serial number check Pick & packing process must be serialization enabled Other WH processes are affected as well Inbound / outbound interfacing required Is your 3PL ready? Goldfish ICT Services BV External Serialization Seminar 25 March

19 Serialization framework Supply chain management Strategic intent Facility design GXP compliance Automation & IT Organizational change management Goldfish ICT Services BV External Serialization Seminar 25 March

20 Org. change management - artwork Artwork changes 2D barcode on blister, packed product (2D) barcode on packaging (packs, cases) Review/enhance labels on shipper boxes and pallets with unique ID s Goldfish ICT Services BV External Serialization Seminar 25 March

21 Org. change management - labels Who is already examining the artwork? Goldfish ICT Services BV External Serialization Seminar 25 March

22 Org. change management Aligning all departments Aligning CMO s, brand owners, suppliers (hard/software) Many systems / interfacing involved System integration testing (chain) Goldfish ICT Services BV External Serialization Seminar 25 March

23 Serialization framework Supply chain management Strategic intent Facility design GXP compliance Automation & IT Organizational change management Goldfish ICT Services BV External Serialization Seminar 25 March

24 Serialization and GxP compliance Revise controlled documentation SOPs (e.g. line setup, reconciliation, sampling/testing) Training modules (Master) Batch Records Revise controlled labels and packaging Changes to approved primary/secondary packaging Close collaboration needed among equipment engineers, packaging engineers, printed-material suppliers, regulatory specialists, QA professionals Validate equipment, processes and software Validation of cloud-based vs. local solution Establish Validation master plan Establish URS/FS/TS and DQ/IQ/OQ/PQ protocols Revalidate packaging lines Reduce validation effort by adopting risk-based approach Goldfish ICT Services BV External Serialization Seminar 25 March

25 Serialization framework Supply chain management Strategic intent Facility design GXP compliance Automation & IT Organizational change management Goldfish ICT Services BV External Serialization Seminar 25 March

26 Benefit realization - coverage Goldfish ICT Services BV External Serialization Seminar 25 March

27 Serialization: burden or benefit? Better product authentication and integrity Serialization provides visibility in the supply chain Recall management is more efficient and detailed Counterfeiting products can be identified earlier requires authentication checks in the supply chain and at POS/POC Building a stronger and reliable brand Goldfish ICT Services BV External Serialization Seminar 25 March

28 Supply chain up Adapting production lines Changes to current IT landscape Serialization repository Extensive interfacing Shipping / warehouse processes Artwork review Change management (internal/external) GxP compliancy Serialization and reporting only? Or setting up full track & trace visibility in the supply chain adding value Goldfish ICT Services BV External Serialization Seminar 25 March

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