Mass Serialization for Track & Trace and epedigree based on 2D Matrix Code

Mass Serialization for Track & Trace and epedigree based on 2D Matrix Code Christian Riediger, SCM Bayer Schering Pharma

Topics Background from Bayer Healthcare perspective The 2D Matrix Code Developments in other Countries Implementing a Mass Serialization System Project Challenges and Conclusion Page # 2

Background from Bayer Healthcare perspective Animal Health (2005): IFAH (International Federation for Animal Health) has agreed on a unique worldwide identification principle for animal health products. Data Matrix ECC200 was selected because of it s small size, error correction, low contrast requirements and the amount of data that can be encoded compared to one-dimension codes. Page # 3

Background from Bayer HealthCare perspective Pharma (2007): Under the presidency of A. Higgins (former CEO of Bayer HealthCare), the EFPIA* working group Distribution has worked out an identification system for prescription drugs composed of a standard serialized 2D Data Matrix Code on unit pack level and a database system accessed by all relevant parties in the supply chain to verify the integrated serial number. *EFPIA = European Federation of Pharmaceutical Industries Associations Page # 4 With this system, the following goals shall be achieved: - Raise the hurdles for counterfeiting of medicines - Product verification on the point of dispense - Limit reimbursement fraud - Unify coding systems across the EU Ultimately, the aim is to enhance security for patients!

The 2D Matrix Code (ECC 200) Technical Details Full ASCII character set Datacapacity: 1 to 2335 characters Variable, data-dependent size ECC200 - Reed Solomon Error Correction (the code can be up to 25% defective) Defined boundary line as identifier Page # 6

Why is the 2D Data Matrix Code Popular? Page # 7

The EPFIA proposed content of the 2D Matrix Code Batch Product Expiration Serial Number number identification Date unique, Global fraud resistant Trade Item Number (GTIN) With With Application Application Identifier Identifier (AI) (AI) 10 01 17 21 Example: Example: (10)KP12345 (21)245673291386 (01)01234567890128 (17)090800 Expiration Serial GTIN Batch number date Format: Randomized Code version: Marketing (17)YYMMDD authorization serial 24x24 owner s number modules number(fix) (up to 20 chars), cryptographically Size on product: secured appr. 9x9mm I N N N N N N N 0 0 0 0 Indica tor Article number (1 to 99999) 1 Check C Always 0 Id number (GS1) Product Code Page # 8

Turkey It is obligatory for any product manufactured after 01/01/2010 to bear a 2DMC Code - regulation regarding packaging & labeling of medicinal products for human use Target is to reduce counterfeits and reimbursement fraud Database owned and managed by Turkish health authorities Phase 1: corresponding to EFPIA coding proposal for unit packs - readiness achieved in 2009, mass serialization started beginning of 2010 Phase 2: additionally, full aggregation is required by 01/2011 - allow traceability over the whole supply chain - postponement expected (no data interchange concept defined up to now) Page # 10

France The French Agency for the Safety of Health (AFSSAPS) decided - to extend the product code (CIP) from CIP 7 to CIP 13 characters - to switch from Code 39 to DataMatrix (transition period until 2011 regulated) 2D Matrix Code mandatory from 31/12/2010 for all pharmaceutical products (Rx & CC) - content of the code: batch number expiration date CIP 13 no. (product number) no serial number required Page # 11

Brazil Brazilian law calls for serialization with a 2D Matrix code on security labels 25 mm 19 mm Implementation timelines (06/2010) have been removed by health authorities (ANVISA), evaluation of alternatives ongoing (inline printing vs. labelling) National Pharma association (INTERFARMA) strongly lobbying to avoid labels, discussions ongoing Page # 12

China Linear EAN/UCC-128 Surveillance Code 20 digit randomized number to identify each package of the finished product. Aggregation (shipper, pallet) required. Currently only traditional Chinese medicine, but implementation timelines of max. 6 month expected. Expected timelines (not declared and finalized by authority) - 2010: antibiotic products and injections which are covered in national essential drug list - 2011: the rest of products in the national essential drug list - 2012: all locally produced products will be covered Page # 13

Korea Introduction of Code 128 (linear Barcode or 2D Matrix Code) by Jan 2012 Content of the code (similar to France): - GTIN (Global Trade Item Number), - Batch number - Exp. date Timelines: - Special Designations: Jan1, 2012 - All prescriptions except OTC and Orphan drugs, Jan1, 2013 Ministry of Knowledge Economy (MOKE) explained that they plan to implement RFID to 50% of the products by 2015, implications to be clarified Page # 14

USA Californian epedigree postponed for 50% of all pharmaceuticals to 2015 & to 2016 for remaining 50% FDA provided final guidance for product serialization on March 26, 2010 - no implementation timelines defined for a federal law - no data carriers defined (e.g. 2D Matrix Code, RFID) - SNI for most prescription drugs should be a serialized NDC code (sndc) Format: Variable data (batch number, expiry date) not officially requested Page # 15

EFPIA Pilot Sweden - Overview and Key Figures Pilot project successfully completed Key figures - 25 pharmacies in the greater Stockholm area (owned by Apoteket AB) with a total of 180 dispensing points - 25 products (SKUs) with total of 110.000 packs - 14 manufacturers Operational phase - 4 months: 17 Sept 2009 29 Jan 2010 Excellent technical results - Response time 99,7% < 1 sec, - Minor issues regarding work flow in pharmacies - Positive feedback from pharmacists Page # 16

EFPIA Way Forward Continue discussions with stakeholders on European level Develop strategy for implementation of expected requirements - conduct survey to understand different market conditions - develop appropriate governance models for different markets - develop strategy for communication with stakeholders in different markets Page # 17

BHC Core System Due to the upcoming legal requirements for mass serialization with 2D Matrix Code in different countries, a BHC core system has been developed with the following components: - A central database to generated and store unique serial numbers - A middleware to connect the line equipment (printer/camera) to the central system, enabling autonomous operation of the production sites - A line controller system to handle mass serialization on each single production line (SKU level) Page # 19

Implementing a Mass Serialization System (spec.) Centrally generated serial numbers to avoid company internal duplicates and to improve security by validating the incoming serial numbers (Contract Manufacturer Interface) To prevent a serial number run-off, unused/free serial numbers should be stored on all production plants by using a buffer of the central system on each plant The global system should be connected to the government databases The system should be fully integrated to the shop floor level Autonomous operation without continuous connection to higher layer system to overcome network interruptions Page # 20

BHC Core Solution Standard Line Equipment Decision criteria for the system selection - Performance (max. 400 cycles / min) - Print Quality (ISO Grade C at 400 cycles/min) - The system components can be integrated in a production line or installed as a separate fully equipped conveyor belt - Compatibility with system architecture Page # 21

Bayer Core Solution System Architecture Central creation and storage of unique randomized serial numbers ERP System External DBs (e.g. ITS Turkey) Company DB External Level Corporate Level Local / Site Level MES System T&T Module Warehouse Connection (Commissioning devices) Contract Manufacturer (External serial number management) Single Unit / Line Controller Line Level Printer Camera Printer Camera Page # 22 Handheld Scanner

Project Challenges and Conclusion Harmonize all relevant parties in the overall project - Artwork changes of packaging material - Handling of imported products (pre-printing/printing in the relevant country) - Integrate partner companies (Contract Manufacturer) - Setup of the IT infrastructure for the equipment installations - Timing of the line equipment installations to minimize production downtimes Find position & space in legacy lines Optimize the inkjet printer in regard to a good printing contrast Page # 24

Project Challenges and Conclusion Selection of the right carton quality due to the printing on a lacquer free area / raw area > tapering of the ink Space problems on small folding boxes (Turkish requirements) - exact positioning required - it is not possible to print an OCR font for the human readable data on all folding boxes Page # 25

Project Challenges and Conclusion Due to the ongoing moving target, this is a very challenging project. - California epedigree law (postponement 01/2009 ->01/2015) - Turkey (postponement 01/2009 -> 06/2009->01/2010) - Brazil (01/2012)? - Spain, China, Korea,? Bayer is prepared to install the system for all relevant countries and supports/drives the idea of one harmonized coding solution worldwide. Page # 26

Christian Riediger Bayer Schering Pharma AG PS PH Supply Chain Management Supply Strategy & Optimization E-mail: christian.riediger@bayerhealthcare.com Internet: http://www.bayerscheringpharma.de Page # 27

Backup Page # 28

Aggregation with 2DMC/RFID (parent/child relationship) Item Bundle Case/Multi-Pack (2DMC/RFID) Pallet (2DMC/RFID) Page # 29

Qualification of the 2D Matrix Code ISO 15415 Evaluation Parameters Symbol contrast - Symbol Contrast is the value difference between light and dark symbol elements, and between the quiet zone and perimeter elements. Fixed Pattern Damage - Fixed Pattern Damage refers to finder pattern and clock pattern damage. Axial Non-Uniformity - Axial Non-Uniformity is the amount of deviation along the symbol s major axes. Source: Handbook Biotech Supply of the Microscan Chain Academy, Quadrus San verifier Francisco, 26th of October 2010 Page # 30

Qualification of the 2D Matrix Code ISO 15415 Evaluation Parameters Grid Non-Uniformity - Grid Non-Uniformity refers to cell deviation from the theoretical or ideal grid intersections as determined by the reference decode algorithm. Modulation - Modulation refers to the reflectance uniformity of a symbol s light and dark elements. Unused Error Correction Capacity - Unused Error Correction Capacity indicates the amount of available error correction in a symbol. 100% Unused Error Correction capacity is ideal. Source: Handbook Biotech Supply of the Microscan Chain Academy, Quadrus San verifier Francisco, 26th of October 2010 Page # 31

EFPIA s Point of Dispense (PoD) verification concept helps to improve patient safety Pharma Manufacturer Wholesaler Wholesaler Pharmacist/ Hospital Patient Product Flow Unique Serialization Verification Verification Dispensing 2D Data Matrix on 2 nd pack Data Transfer Product Serialization Database Product and Data Flow End-to-End With the EFPIA concept: Centralized Design Page # 32

Governance model can be developed as well based on distributed system design Product and Data Flow End-to-End With the EFPIA concept: Distributed Design Pharma Manufacturer Pharmacist/ Hospital Wholesaler Wholesaler Patient Product Flow Verification Unique Serialization Verification Dispensing 2D Data Matrix on 2 nd pack Wholesaler Database optional Manufacturer Database Data Transfer Pharmacies Database Page # 33