Implementing Unit-level Serialization on a New Packaging Line Mike Salinas Director of Manufacturing Technology M+W U.S., Inc. April 24, 2013
AGENDA The Counterfeit Drug Problem The Potential Market an International Focus! Industry Regulations Cradle To Grave E-Pedigree Serialized Solution Layered Model 3 Pieces to the Puzzle Challenges & Lessons Learned Reality Check
THE GLOBAL COUNTERFEIT DRUG PROBLEM A $200B Market Prompting massive demand for action: Patient Safety New & pending regulations Emerging requirement for product verification and authentication Much confusion & uncertainty
THE POTENTIAL GLOBAL MARKET World-wide Track & Trace Hot Spots Law in Place: Canada CA, USA Brazil Ghana Nigeria France Italy Greece Turkey China India Korea Japan Codification Guidelines (Product Type + Batch Information) Laws in Place Pending Regulations Different Categories of Applications Pending Regs: USA Mexico Columbia Chile Argentina Portugal Spain Belgium Slovenia Yugoslavia Romania Russia Egypt & MASS SERIALIZATION Saudi Arabia Malaysia Australia Serialization Guidelines (Mass Serialization/ Track & Trace) A constant global theme that is emerging The Requirement for PRODUCT VERIFICATION based on CODIFICATION This Global anti-counterfeit packaging market is expected to reach $82.2B by 2015
INDUSTRY REGULATIONS USA California is the first and only state that has imposed serialization mandates The California law requires: 50% of a manufacturer's products must be distributed with electronic pedigrees by 2015 The remaining 50% of the manufacturer s products must comply by 2016 Wholesalers and re-packagers must accept and pass epedigrees by July 1, 2016 Pharmacies/pharmacy distribution centers must accept epedigrees by July 1, 2017 EUROPE Turkey has been out in front France a close second Legislature is developing a sound strategy Manufacturer s must submit an outline of the product % make-up by December 1, 2014 By unit volume By product package (sku) type By Drug Product family Nearly everyone in the U.S. pharmaceutical industry expects the FDA, with a congressional grant of authority or without, to require e-pedigrees nationally- -or even a more robust track-and-trace system -- so as to avert a patchwork of 50 state laws kicked off by California's action REST-OF-THE-WORLD China - centralized pedigree and serialization Brazil - pilot unit serialization and scale up over the next few years Approximately 50% of the industry now have at least one product line serialized
CRADLE TO GRAVE E- PEDIGREE Thinking outside the box PRESENT: Pharmaceutical Manufacturers and Packagers Focus Expand past the shop floor Address varying markets Integrate Coding, Serialization and Track & Trace solutions across the entire supply chain! THE PHARMACEUTICAL SUPPLY CHAIN PROPOSED: Full Implementation Requirement
Blister Packaging Line with Serialization, Track & Trace 1. Thermoformer 2. 2. Cartoner Additional hardware and software technology to Vial Needle Adapter Code, Read, Verify and Track the product through the line 1. 3. Checkweigher Vial 4. Case Packer 5. Palletizer 2. 3. 4. 5. Unique codes are applied to: Unit of Sale Case, Carton and Pallet Unit of Sale
SERIALIZATION SOLUTION LAYERED MODEL EPCIS Wholesaler Global Serialization Data vault External Supply Chain Pharmacist ERP Internal Supply (Enterprise) Chain MES Plant A Plant B Contractor Shop Floor A1 A2 B1 B2 C1 Line A1-1 Serialization Solution HMI Cartoner Bundler Case Packer Palletizer EPCIS: Electronic Product Code (EPC) Information Services to enable disparate applications to leverage EPC data via EPC-related data sharing, both within and across enterprises. ERP: Enterprise Resource Planning, MES: Manufacturing Execution System, HMI: Human-Machine Interface of the Serialization apps.
3 PIECES TO THE PUZZLE: 1. M+W Group et al To PLAN, DESIGN, CONSTRUCT, AND VALIDATE PRODUCTION FACILITIEs THAT APPLY AND VALIDATE CODES AT PACKAGING But, getting a serialized 2D bar code on a package achieves nothing if no one is equipped to read it. To exit the shop floor you need to add a DATA MANAGEMENT PLATFORM + SYSTEMS INTEGRATION services 2. Data Management Platform 3. Systems Integration Tracking Track & Trace Diversion Protection Data Gateway Anti-Counterfeiting Cold Chain Verification Business Partners MES/WMS ERP Scanners EPCIS Regulatory Agencies Projects based & enterprise specific platform customization for: Track & Trace Anti-Counterfeiting Recalls/ Returns Diversion Protection Cold Chain Serialization e-submissions The Link To Full Implementation
Reasons for Safety Compliance Protect Brand Rep Improves logistics inventory control & scheduling Improved workflow efficiencies : :
Rationale against Wait and see attitude CA uncertainty Avoid wasting technology investments Supply chain uncertainty
OTHER CHALLENGES ORGANIZATIONAL CONSTRAINTS: Lack of resources Inertia Mergers & acquisitions Product/ technology rationalizations Outsourcing Productivity Losses GLOBAL INFRASTRUCTURE: The infrastructure to read the codes, etc. amongst the Supply Chain partners might not be in place to meet the deadlines FOR HELP 610 427 3310 Responsible person A tosses looming T&T deadline memo B into wastebasket C which causes board D to become unbalanced raising tack E to pop balloon F startling cat G who jumps up, pushing bellows H, thus blowing fan blades I which winds and shortens cord J lifting trough K, causing baseball L to roll down and drop onto PLAY button of cassette player M which turns on specially recorded tape message N which has been embedded with the subliminal message: CALL FOR HELP 610 427 3310
Project Organizational Structure One Team Project Managers Engineering Supply Chain Pkg/ Operations IT/ Logistics Label Control Quality Validation External resources Consultants Systems integrators Hardware and software suppliers, and Packaging equipment vendors End users/ Supply chain customers
SERIALIZATION REALITY Counterfeit Drugs a very serious problem! The Global Counterfeit Drug Market is huge and affects Patient Safety Counterfeit drugs have Brand, Quality, and Regulatory implications as well. The inertia for Serialization Track & Trace is over Pharma is implementing 30% - 50% of drugs are counterfeits US sales losses = $30B/year Investments 15%/year Implementation seems to stop with the pharmaceutical companies The market is disjointed & confused
THE CASE FOR STRATEGIC CONSULTING SERVICES Overall Strategy & Implementation Planning Engineering assessments Corporate Site and/or Line level Line Retrofit Evaluations URS and FRS development Serialization Awareness & Technology Training Proof-of-principle pilot and implementation plan management Serialization Technology Vendor Evaluations, Recommendation & Selection
THE CASE FOR TECHNOLOGY INTEGRATION SERVICES Device Level: Enterprise Level: o Encoding systems o Machine-vision Packaging Line Level: Configuring the Serialization software to manage the: o Data o Aggregation o Product and line recipes, o Business logistics o Providing access between critical data points from various packaging lines to ERP, EPCIS, and other IT business systems o Capturing the data and providing a data repository e.g. SAP Aii/OER o Establishing and allocating serial numbers, and o Managing the process, work orders, and e-pedigree
Lessons Learned One Team Committed resources Define your as is condition Standardize Start Now!!!
Do: Start Now How many lines to serialize Which regulations dictates deadline Design and be ready Implement as regulations solidify Multi-site, lines, time zones Don t: Wait Strained industry resources Equipment lead times are extending Production requirements Implementation times add complexity
FAST FORWARD ENFORCEMENT Push back from the Supply Chain stakeholders CRYSTAL BALL: Time will tell Will US implementation be delayed? Will the law be challenged? Is there some middle of the road alternative?
Thank you for your attention! Mike Salinas Director of Manufacturing Technology M+W U.S., Inc. E-mail: mike.salinas@mwgroup.net Phone: +1 610 427-3310 Booth # 3628