Track Trace Implementation Challenges Solutions Sourabh

Track & Trace Implementation Challenges & Solutions Sourabh Shetty Business Development - East Europe & CIS Email: sourabh. shetty@acg-world. com Phone: +91 9167971518 Your Global Partner for Manufacturing, Packaging and R&D Solutions Copyright © ACG Worldwide. All rights reserved

PRESENTATION POINTERS • ACG group at a glance. • Challenges for Track & Trace Project. • Project Life cycle. • ACGI Solutions & Innovations for Track & Trace. • Why ACGI as the Technology Partner? Copyright © ACG Worldwide. All rights reserved

COMPANY PROFILE Over 5 decades of dedication And expertise in Pharma and Packaging industry. § Multi – Faceted Global Group § Serving the pharmaceutical industry for over 55 years § Having 15 world-class factory locations manufacturing hard gelatin capsules, encapsulation & tabletting equipment, barrier packaging films, blister – cartoning lines and end-of-line solutions, and camera inspection systems Copyright © ACG Worldwide. All rights reserved

ACG VALUE CHAIN ACG-APT Copyright © ACG Worldwide. All rights reserved

GLOBAL PRESENCE OF ACG UNITED KINGDOM CROATIA UNITED STATES CHINA INDIA THAILAND INDONESIA BRAZIL PHYSICAL PRESENCE IN 8 COUNTRIES | 100+ AGENTS | SERVING MORE THAN 100 COUNTRIES Copyright © ACG Worldwide. All rights reserved 07 GLOBAL PRESENCE

Copyright © ACG Worldwide. All rights reserved

ACG INSPECTION IN TRACK AND TRACE END TO END SOLUTION PROVIDER Sr. No Points Units 1 Total no. of instances worldwide 700 + 2 Total no. of Customers 139 + 3 No. of countries 16 + 4 No. of lines installed out of India 50 + Implementation @ various countries like USA, Brazil, UK, Turkey, Jordan, Saudi Arabia, UAE, Indonesia, Bangladesh Copyright © ACG Worldwide. All rights reserved

CONFIGURABLE FOR MULTIPLE COUNTRY REGULATIONS Key Highlights Regulatory Board GS 1 compliance India China Saudi Arabia Jordan Brazil Europe USA DGFT CFDA SFDA JFDSA ANVISA EFPIA HDMA/HDA GS 1 - GS 1 GS 1 India DGFT Europe China SFDA South Korea KNIH ACG Inspection Verif-i Brazil ANVISA USA HDMA Turkey Saudi Arabia SFDA Copyright © ACG Worldwide. All rights reserved

CHALLENGES FOR TRACK & TRACE PROJECTS Challenges Internal • Design, implementation and ongoing costs. • Integration with existing systems. • Definition of system architecture. • Available Qualified Employees. • Identification of Contractors/Suppliers. Copyright © ACG Worldwide. All rights reserved External • Lack of standard system architecture. • Lack of clear standards for interoperable data exchange. • Lack of clear regulatory requirements. • High cost of system components like software, hardware and services.

IMPLEMENTATION CHALLENGES • • • • Understanding the Regulation Selecting the right Track and Trace partner Managing Master Data Scalable Solution Cost for Implementation (Time, Money and Resources) Selecting right solution for each packaging line Modification in Machinery in packaging lines Managing the project execution Not enough space on the line Not enough space on products for printing Artwork change impact Rejection and reconciliation Impact on Productivity Copyright © ACG Worldwide. All rights reserved

MEETING THE CHALLENGES • • Understand the purpose - define clear objectives Collaborate with stakeholders Identify, then avoid the traps Produce detailed requirements Set realistic timelines – then monitor them Base solutions on global standards Pilot, phase deployment & ramp up Stabilise, then leverage Copyright © ACG Worldwide. All rights reserved

TRACK & TRACE IMPLEMENTATION TIMELINE # Activity Time required 1 URS (User Requirement Specification) formation 1 -2 months 2 Supplier Evaluation 1 -2 months 3 Ordering Process 1 month 4 Setting up IT Infrastructure 1 month 5 Manufacturing lead time & FAT 2 -3 months 6 Delivery of Equipment 1 month 7 Installation & Commissioning 15 -20 days 8 Training to the team 4 -5 days. 9 Actual batch production trial (depends on batch size) 7 -10 days 10 Serialized batch to hit market 3 -4 months Total Time for Compliance 12 – 15 months Copyright © ACG Worldwide. All rights reserved

ACGI MODULAR SOLUTIONS Copyright © ACG Worldwide. All rights reserved

FULLY MANUAL SERIALIZATION AND AGGREGATION Offline Carton Serialization Scanner based Aggregation Offline Serialization for

SEMI AUTOMATIC SERIALIZATION AND AGGREGATION Scanner Base Aggregation On-line Carton Serialization Copyright © ACG

FULLY AUTOMATIC CARTON LINE Online Carton Serialization Copyright © ACG Worldwide. All rights reserved

FULLY AUTOMATIC BOTTLE LINE Online Bottle Serialization Copyright © ACG Worldwide. All rights reserved

COMMUNICATION WITH CLOUD SYSTEMS Copyright © ACG Worldwide. All rights reserved

ACGI INNOVATIONS IN TRACK AND TRACE • Our equipment is known for its aesthetics and safety. ENSURA Combo Check weigher CPIR-XL Copyright © ACG Worldwide. All rights reserved CPIR NANO Length 600 mm VOYAGER Kiosk for Aggregation HAWKEYE Autofocus Collation unit NAVSTAR

3 RD PARTY SOFTWARE SOLUTION PARTNERS SOME OF OUR PROMINENT HARDWARE PARTNERS Copyright ©

SOLUTION OVERVIEW • Fully integrated global serialization solution • Customized solutions for different types of packaging lines • Integration with various third party environments • Value centric approach • Domain expertise • Exacting standards Copyright © ACG Worldwide. All rights reserved