Implementation Challenges & Solutions 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

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?

COMPANY PROFILE Multi – Faceted Global Group 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

ACG VALUE CHAIN ACG-APT

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 07 GLOBAL PRESENCE

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

Configurable for Multiple Country Regulations Key Highlights India China Saudi Arabia Jordan Brazil Europe USA Regulatory Board DGFT CFDA SFDA JFDSA ANVISA EFPIA HDMA/HDA GS1 compliance GS1 - ACG Inspection Verif-i India DGFT Europe China SFDA South Korea KNIH Brazil ANVISA USA HDMA Turkey Saudi Arabia SFDA

Challenges for Track & Trace Projects External Internal Design, implementation and ongoing costs. Integration with existing systems. Definition of system architecture . Available Qualified Employees . Identification of Contractors/Suppliers . Lack of standard system architecture. Lack of clear standards for inter-operable 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

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

Track & Trace Implementation Timeline # Activity Time required 1 URS (User Requirement Specification) formation 1-2months 2 Supplier Evaluation 1-2 months 3 Ordering Process 1 month 4 Setting up IT Infrastructure 5 Manufacturing lead time & FAT 2-3 months 6 Delivery of Equipment 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

ACGI Modular Solutions

Fully Manual Serialization And Aggregation Fully Manual serialization and Aggregation solution Fully Manual Serialization And Aggregation Pallet Aggregation Scanner based Aggregation Offline Serialization for Labels Offline Carton Serialization

SEMI AUTOMATIC SERIALIZATION AND AGGREGATION On-line Carton Serialization Scanner Base Aggregation Semi-Automated Aggregation Pallet Aggregation

Fully Automatic Carton Line Online Carton Serialization Online Carton Aggregation Pallet Aggregation

Fully Automatic Bottle Line Online Bottle Aggregation Pallet Aggregation Online Bottle Serialization

Communication With Cloud Systems

ACGi Innovations in Track and Trace Our equipment is known for its aesthetics and safety. ENSURA Combo Check weigher CPIR-XL CPIR NANO Length- 600mm VOYAGER Kiosk for Aggregation HAWKEYE Autofocus Collation unit NAVSTAR

3rd Party Software Solution Partners Some Of Our Prominent Hardware Partners

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

Key Global References

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