Track and Trace System

A Track and Trace system is a mass serialization solution for pharmaceutical and other industries that prints a unique identifying code onto each product after it has been packaged.

1. Presented by- Debabrata Golder Indian Institute Of Packaging,Mumbai Mb:8668909545;Email: [email protected] Track And Trace System The Fight Against Counterfeit Products

2. Contents What it is ? Why is this Security Measure Needed? Description of the different modules Primary Level Secondary Level Tertiary Level Data Storage Benefits through this syste Conclusion References

3. What it is ? In distribution and logistics of many types of products, track and trace or tracking and tracing, concerns a process of determining the current and past locations (and other information) of a unique item or property. This enables individual products to be tracked throughout the supply chain, from production to the end consumer.

4. Why is this Security Measure Needed? Consumer safety is the primary objective. Automatically detect expired products. Track and Trace enables counterfeit products to be easily identified. Helps you to protect brand. Helps you to protect consumers. Various governments demand the mandatory introduction of security systems.

5. Description of the different modules The heart of the Track and Trace system is the CPS(Carton Printing System) module, which consists of a printer and a camera to automatically print and verify products. After the tracking data is printed onto the product, it is automatically checked for accuracy by the camera , which reads each printed digit (OCR/OCV). Within milliseconds it compares the human-readable text with the 2D data matrix code and verifies it for accuracy.

6. (a) Primary Level Incorporation of two dimensional (2D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the primary pack.

7. (b) Secondary Level Incorporation of one or two dimensional (1D or 2D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the secondary pack.

8. (c) Tertiary Level Incorporation of one dimensional (1D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number. (GTIN) along with batch number, expiry date and a unique serial number [Serial Shipping Container Code (SSCC)] of the Tertiary pack.

9. (01) GTIN-14 data format. (17) The expiration date of the product in YYMMDD format. (10) Batch or lot number of the product. (00) The numeric serial number of the Shipper/Carton/Tertiary level. (21) The serial no of the product which should be alphanumeric and varying from 1to 20 digit.

10. Data Storage The manufacturer shall maintain the data in the parent-child relationship for all three level of packaging i.e. Primary, Secondary and Tertiary and their movement in its supply chain. The data shall be uploaded on the central portal of the Government by the manufacturer or its designated agency before release of the drugs for sale or distribution.

11. Benefits Protects patients through improved product security Improves customer confidence: physician, pharmacist, and patient Helps law enforcement combat drug counterfeiting Prepares company to meet regulatory compliance requirements Helps company gain greater insight into demand patterns and inventory management.

12. Conclusion In recent years, track and trace systems have shown to be an effective tool for increasing pharmaceutical companies competitiveness and capacity to prevent thefts and counterfeiting, while reducing recall frequency and costs.

13. References The Gazette of India Extraordinary Part-I, Section- I,Government of India,Ministry of Commerce and Industry,Department of Commerce,Directorate General of Foreign Trade,Public Notice No. 4 /2015-2020,New Delhi, Dated the 1 April, 2015 www.fda.gov DGFT Public Notice No. 59(RE-2010)/2009-2014 dated the 30 th June, 2011 www.boschpackagingservices.com http://www.gs1india.org.in/gs1barcodes/pc_index.htm http://www.gs1.org/barcodes

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