Traceability in a Global Pharmaceutical Supply Chain with SAP Track & Trace Solutions. Dr. Oliver Nürnberg Product Owner SAP Life Sciences March 2013

Transcription

1 Traceability in a Global Pharmaceutical Supply Chain with SAP Track & Trace Solutions Dr. Oliver Nürnberg Product Owner SAP Life Sciences March 2013

2 Agenda Market Drivers SAP Track & Trace Solution Portfolio Protect your (Customer s) Brand with SAP Global Batch Traceability (SAP GBT) Serialization - Comply with Legal Requirements with SAP Object Event Repository (SAP OER) Process Monitoring - Find Value Beyond Compliance with SAP Event Management (EM) Achieve True Product Traceability with SAP 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 2

3 Market Drivers

4 Market Drivers Compliance & Brand Protection Protect the End Customer and your (Customer s) Brand in case of product issues Act swiftly on product batch issues to protect the consumer & the brand from associated liabilities & cost of recall, whilst ensuring timely reporting to authorities 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 4

5 Market Drivers Compliance to serialized product directives Comply to directives enacted to avoid the proliferation of falsified medicines Enable serialized product traceability and ensure compliant reporting 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 5

6 Market Drivers Achieve Added Business Value (find value beyond compliance) Assure compliance to internal processes and reduce, for example, order-to-cash cycle times Monitor the performance of processes Order-to-cash with Fulfillment Visibility Procure-to-pay with Procurement Visibility Visibility for Goods and Assets in-transit 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 6

7 SAP Track & Trace Solution Portfolio

9 SAP Track & Trace Solution Overview Contract Manufacturers Suppliers Pharma MAH Authorities SAP Global Batch Traceability provides a total view of the entire product genealogy and its distribution SAP Object Event Repository (& SAP Auto-ID Infrastructure) provides a cross-system product serialization repository as a basis for reporting to authorities Distribution Center Wholesaler SAP Event Management provides track-and-trace for process monitoring, automated exception resolution, proactive alerting, and extensive reporting Patients & Consumers Hospitals Pharmacies 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 9

10 The complementarity of SAP GBT and OER Product Batch Genealogy & its distribution item serialization of finished product Corporate batch genealogy ingredient material genealogy to finished product From serialization of finished product at packaging line to downstream and reporting Purchase Orders: Who was the supplier of a certain batch? Component batches Finished product batch ID Deliveries: Who was this batch distributed to? Serialization of a finished product at packaging line Aggregation during packing Batch genealogy & distribution S/N Batch ID as attribute to S/N in OER Related business document, e.g. delivery S/N SAP Global Batch Traceability SAP Object Event Repository 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 10

11 Protect your (Customer s) Brand with SAP Global Batch Traceability (SAP GBT)

12 Customer Case We loaded the data of a complex batch investigation we had a few months ago into SAP Global Batch Traceability (GBT) and compared the time needed for the investigation: Before GBT this complex batch investigation took us 2 weeks. With GBT it took us 35 seconds. Life Sciences Customer testing SAP GBT 2 Weeks Before GBT Runs 34,560x faster 35 Seconds After GBT This is possible due to the use of the NetWeaver Graph Engine that allows a much faster search for all objects related to an item SAP AG or an SAP affiliate company. All rights reserved. Customer 12

13 What Is SAP Global Batch Traceability? What can you do with SAP Global Batch Traceability? Trace complete product batch genealogies, their origin of supply as well as their internal and external distribution across distributed SAP ERP and non-sap batch record systems. Report on the corporate internal and external distribution of bad batches Business Value Protect the brand owners consumers Protect the brand in case of product issues with new speed of action and extended reach Comply to reporting timeline requirements of authorities associated with recalls Assure that no inferior materials have been introduced into product manufacture from increasingly global supply chains 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 13

14 What Does SAP Global Batch Traceability Deliver? 1. Capture & link batch usage across distributed systems 2. Explore / investigate the batch genealogy 3. Fast Reporting to drive precision recall Search Investigate Report SAP Global Batch Traceability Repository Multiple SAP ERPs Multiple 3 rd party systems Business Partner systems Capture the cross-business and crosssystem batch origin and usage as well as their external and internal distribution record Investigate your product batch genealogy with a powerful search, and graphic exploration of your cross-system batch genealogy and its distribution One click reporting with a selection of multiple batches to understand immediately the external and internal distribution record and material balances 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 14

16 Easy and Fast Reporting Get a report on the external distribution of (bad) batches based on the delivery item record to initiate recall action 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 17

17 Act based on readily available Results Get a report on the stock levels of (bad) batches an RFC call to connected ERP systems fetches the latest internal stock distribution which lets you initiate the restriction of batches still on-hand in your company 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 18

19 Serialization Comply with Legal Requirements with SAP Object Event Repository (SAP OER)

21 scheduled In effect Codification / Label Tracking Serialization End-2-End / Pedigree Track & Trace Product, Batch, Expiration Date encoded in Barcode pre-printed serialized package labels issued by government agencies No computerized tracking of labels/ids Serial number on package level Serial numbers stored at manufacturer Authentication only possible via direct request to manufacturer Serial number on package level Serial numbers stored at manufacturer Reporting of serial numbers to authorities or central, non government database to enable authentication Serial number on package level Serial numbers and Aggregation stored at manufacturer Reporting of serial numbers to authorities and/or trading partners to enable full track & trace France Italy: Bolinos India: government procurement & export only, GS1, currently no reporting China: Government reporting, serial numbers supplied by Government, non GS1 Turkey: Government reporting (ITS) and aggregation (PTS); GS1 Serbia plenty of other countries Argentina: selected drugs only, GS1, Government reporting! Aggregation optional but recommended as supply chain partner have to report as well! Saudi Arabia 03/2015 South Korea: Jan 2015 serialization only? No reporting req s known so far European Union: EFPIA (serialization) 2. EDQM (serialization + optional aggregation) US 2015: Lot-level traceability Germany: securpharm pilot - Serialization only, Rep. into central, non-gov DB Saudi Arabia 03/2016: probably Government reporting incl. aggregation, GS1 mandated US 2017: probably GS1, Serialization only, reporting to supply chain partner Brazil: new guidance published end of 2013 Effective end of 2017 Jordan: 2017 Ukraine: draft, potentially 2017, currently evaluating the EDQM model and Turkey ITS/PTS US 2023: probably GS1, Serialization & Aggregation, reporting to supply chain partner HL_REGULATORY_OVERVIEW.PPTX SAP AG. or All an rights SAP reserved. affiliate company. All rights reserved. 22

22 Customer Case Leading Pharma companies use SAP Object Event Repository as their corporate serialization repository for compliant reporting to authorities 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 23

23 Serialization in Pharma with SAP Object Event Repository 1. Capture serial numbers from production & distribution 2. Monitor serialized product lifecycle events and processes 3. Effective reporting to authorities compliant to serialization directives Authorities SAP Object Event Repository Packaging Lines Distribution sites Business Partner systems Capture serial numbers for pharma products & aggregations from packaging lines, distribution sites and business partners Monitor product item lifecycle events and assciated business processes Search on serialized items and attributes Create messages to authorities in respective compliant format(s) Currently covered in the Regulatory Reporting Add-on for SAP OER Further Development in Progress 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 24

24 Co-Innovation Topics Development Projects Customer Round Tables Serialization Round Table drives SAP Development Steering Board to drive Serialization Topic LSEC 30+ members Quarterly Face-to-Face meetings Intermediary calls on focus topics Co-innovation Serialization Round Table Batch Traceability Round Table. 4 Co-Innovation teams 9 companies participating Prep Calls and Workshops in WDF & NSQ in Feb./March 2014 Serialized Track & Trace GBT Development (done) Regulatory Reporting Enhanced Serial Number Management Supply Chain Integration Shop Floor Integration 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 25

25 Regulatory Reporting for SAP OER Solution Architecture Receiver 1 (IST Turkey) Receiver 2 (PTS Turkey) Receiver 3 (SFDA China)... ITS message PTS message SFDA message Other formats Regulatory Reporting Add-On for SAP Object Event Repository Flexible configuration engine Automatic creation & transfer of notifications Central UI for visibility & control Flexible message dispatching SAP NetWeaver Process Integration Generic Notification SAP Object Event Repository EPCIS event capture notification SAP Auto-ID Infrastructure CMO 3rd party DC 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 26

26 SAP Serialized Track & Trace for Pharmaceuticals Scope Overview Existing capabilities Extended capabilities Reporting Targets China FDA Turkey MoH (ITS&PTS) Content for Turkey PI Content for China Serialized Track & Trace ERP Argentina EU Brazil.all other countries! Authorities Content for Argentina Content for Content for Korea.. Regulatory Reporting Framework Master Data Mgmt Serial Number Sources China FDA. Authorities Content for Inbound Serial Numbers Archiving Content CMO S/N Exchange Ranges and List Pull Also covering the CMO view Simple Packaging Line Integration Template Content only Contract Manufacturers Packaging Line Content for S/N Exchange with CMO Content for Packaging Line Integr. Advanced Serial Number Management OER / AII Screens & web-services to capture S/Ns in WM/eWM 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 27

27 Process Monitoring Find Value Beyond Compliance with SAP Event Management (EM)

28 Customer Case A leading Pharma customer uses the in-built SAP Event Management capabilities in SAP Object Event Repository in order to perform distributed sales order tracking (across multiple ERP instance) 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 29

29 SAP Object Event Repository Is Based on SAP Event Management and You Can Leverage Additional Value 1 Need for visibility across partners in the extended supply chain 2 Need to coordinate across multiple IT environments Goal: Manage by exception reduced time to action & less fire-fighting with Event Management 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 30

30 SAP Event Management Use Cases You Can Implement SAP Event Management Order-to-cash: Fulfillment Visibility Does your customer complain about missed delivery dates? Visibility for Goods and Assets in-transit Where are my goods? How does my asset availability look like? SO issued 22.34% 1.44% 26.8% Customer Invoiced POD Shipment execution (SAP TM) Carrier GL GI for SO Manufacturer Production start/end 22.34% 26.8% Delay Cancelled Block Procure-to-pay: Procurement Visibility How can I ensure proper operations when I don t have visibility into when procured goods will arrive? Parcel Tracking for postal companies/shippers Where is my parcel? PO issued Supplier Manufacturer Order Receipt Warehousing Transportation Deliver to Customer Acknowledgement ASN Shipment execution (SAP TM) Goods Received Invoice Received Payment Date/Qty Change Cancelled Delay 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 32

31 Achieving Global Product Traceability

32 How Do SAP s Track and Trace Products Complement Each Other, and How Do They Differentiate? SAP Global Batch Traceability: visibility into a cross-system product genealogy and related tracked objects Which batches went into which subsequent batches? From whom was a batch procured, and to whom was it distributed? What is the material balance of a batch, and what remaining stock quantities do exist? SAP Object Event Repository for serialized product event traceability What lifecycle events happened to a product item? When were product items unpacked from a specific case id? Is this a valid product id, and does its lifecycle look credible? SAP Event Management for Supply Chain and Process Visibility Where exactly are assets and goods, also while intransit? Which processes are currently at risk? What are the granular events of a delivery or a shipment? 2014 SAP AG or an SAP affiliate company. All rights reserved. Customer 34

33 Thank you Contact information: Dr. Oliver Nürnberg Product Owner SAP Life Sciences SAP Application innovation SAP AG Dietmar-Hopp-Allee 16 D Walldorf, Germany T F M oliver.nuernberg@sap.com SAP AG or an SAP affiliate company. All rights reserved.

36 Where to Find More Information: SAP Global Batch Traceability Get a quick overview as to the value, the solution and 2 example demos see the SAP GBT Solution Video on YouTube Technical Guides such as Master Guide can be downloaded from SAP AG or an SAP affiliate company. All rights reserved. Customer 38