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E-Pedigree Track & Trace Solution

An epedigree is simply an electronic document which satisfies a pedigree requirement. The primary purpose of an epedigree is to protect consumers from contaminated medicine or counterfeit drugs.

E-PDEGREE in Pharma is must for suppliers, Exporters to United States of America from 1st January 2009. As per Public Notice No. 21 (RE-2011) /2009-2014, Govt. Of India, Director General of Foreign Trade, exporters of pharmaceutical products would be required to affix 2D Data Matrix barcode on their products to facilitate tracing & tracking of their products. This trace and track technology, came into effect from 1st July, 2011. As per new circular from US FDA and DGFT (Govt. Of India), all the medicines’ packaging e.g. bottles, blister, vile, etc.. [Primary level packaging], ‘inner’ box [Secondary level packaging], ‘outer’ box; carton/Shipper [Tertiary level packaging], Shrink Wrap and Pallet should contain e-Pedigree.

Solution on offer

2D Data-Matrix barcode with NDC No. [GTIN: Global Trade Item Number] , batch no , expiry date and Unique Running Serial No. (RSN)  will be applied on each SKU.

The data with-in the barcode with other data will be converted into any e format and signed with Digital certificate

Packaging Using Conveyer Belt

On line Packaging of medicines is carried out using conveyer belt application with 2D Data Matrix Barcode, print & apply automation, vision system and rejection system.

Shrink Wrap: Primary Level Packaging

• 2D Data-Matrix Barcode label will be printed and pasted on each bottle / blister / vial, etc.. with the help of automatic print and apply system.
• Barcode contains a unique RSN (Running Serial No.) of bottle / blister / vile No. + GTIN (NDC No.) + Exp. Date + Batch No.
• Filling of medicine [Tablet / Capsule / Liquid / Powder] in the bottle / blister / vile, etc.. will be carried out. [Primary level Packaging]

Shipper Label

• Vision System & 2D Barcode scanning will be done for the validation of primary level packaging.
• Based upon inputs from vision system and 2D barcode scanning , QC will be carried out and based on parameters set , the product will either be accepted or rejected.

Secondary Level Packaging - Pallet Label

• Bottle / blister / vial, etc are packed  in ‘inner’ box [Secondary level Packaging] .
• 2D Data Matrix Barcode label will be printed and pasted on each ‘inner’ box with the help of automatic print and apply system.
• The Barcode contains a unique RSN (Running Serial No.) of ‘Inner’ box + GTIN + Exp. Date + Batch No.
• This 2D barcode contains all the details of the packaged bottles / blisters / vile, etc.. stored in the ‘inner’ box 
• 2D Data Matrix Barcode scanning will be done for the validation of secondary level packaging.

Tertiary Level Packaging: Pallet Label

• ‘Inner’ boxes are packed in the ‘outer’ box i.e. Shipper /Carton [Tertiary level Packaging]
• 2D DataMatrix Barcode will be printed & pasted on ‘outer’ box/Shipper / Carton with the help of automatic print and apply system.
• The Barcode Contains a Unique RSN (Running Serial No.) of ‘outer’ box; Shipper /Carton + GTIN + Exp. Date + Batch No.
• This 2D barcode contains all the details of the packaged ‘inner’ boxes packed  in the ‘outer’ box/ Shipper /Carton 
• 2D Data-Matrix Barcode scanning will be done for the validation of tertiary level packaging.

Final Shrink Wrap Packaging for Palletization

• 2D Data Matrix + EAN 128 Barcode will be printed & pasted on the shrink Wrap with the help of automatic print and apply system.
• The Barcode contains a unique RSN (Running Serial No.) of Shrink Wrap + GTIN + Exp. Date + Batch No.
• This 2D barcode contains all the details of the packaged ‘outer’ box/ Shipper /Carton in the Shrink Wrap-in backend.
• 2D Data Matrix Barcode scanning will be done for the validation of Shrink Wrap packaging for the final level packaging process.

Final Palletization

• 2D DataMatrix Barcode will be printed & pasted on the pallets.
• The Barcode contains a Unique RSN (Running Serial No.) of pallet + GTIN + Exp. Date + Batch No.
• This 2D barcode contains all the details of the packaged Shrink Wrap on its respective pallet-in backend.
• 2D Data Matrix Barcode scanning will be done for the validation of palletization for the final level of packaging process.

Benefits

• Complies with all international standards for exports of Pharmaceutical products.
• Complies with all rules and regulations of Pharmaceutical products’ Exports & Import regulatory bodies like FDA / WHO and GS1, etc.
• 100 % accurate, GS1 approved, standardized package tracing and tracking system for pharmaceutical products.
• Tracking right from  Unscramble, Primary shipper, Secondary, Palletization and Warehouse
• Excellent…‘ready-made’ platform for the implementation of BARCODE/RFID based applications like Work In Progress [WIP] Tracking and finished goods warehouse management system [WMS].
• Advancement in the production facility with highly Automated 100 % accurate DATA capturing and SKU tracing & tracking system.
• ROI due to saving of man-hours, man-power, IT & civil infrastructure.