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Implementing Track & Trace in Pharmaceutical Industry

Written on:October 12, 2012
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Implementing Track & Trace in Pharmaceutical Industry

2D Barcode for Track and Trace
As we all know that as per DGFT circular, Bar-coding on Primary, Secondary & Tertiary is to be implemented following the GS1 guideline. End goal of implementing Track & Trace is counterfeiting and ePedigree is the global solution. Pharmaceutical companies will have to take systematic approach to implement Track & Trace else tomorrow that will directly affect overall operations from sales to dispatch.
Pharmaceutical companies will have to give a serious thought and appoint dedicated team to implement the system; rather dedicated department of Track & Trace should be added. For proper implementation of Track & Trace system involvement and participation of each department is required. Major role playing departments are Packaging, QA, Production and IT.
 
Scientific approach in each step of implementation will ensure success. Linear (1D) Barcode on Tertiary, 2D barcode on Secondary & Primary are required to be printed each having unique serial number (UID). Registration of company with GS1 for company code, allocating item reference number to each product, deciding on packaging indicator and thus getting GTIN for each product packaging is the first step of implementation process.
 
GTIN allocation to each of product individual packaging is the 1st key step. Though simple, you should consider your previous discontinued packaging and future products to come while allocating GTIN. GTIN once allocated and uploaded on GS1, cannot be reallocated till 4 years after expiry of the product. The way you take lot of effort in naming a product, similarly GTIN is a new globally unique name of your product. Your product name doesn’t have a provision of packaging levels, but GTIN has that too. Giving item reference number to each of your product and deciding on packaging indicator are the steps to define GTIN.
Track And Trace
 
GTIN 14 = Packaging Indicator (1) + Country Code (3) + Company Code (4) + Item Reference number (5) + Check Digit (1) (Total Making up to 14 digit numeric code)
 
Simultaneous step is to identify a space to print barcode on different packaging levels. As we know most of the boxes OR cartons have coated / varnished surfaces & printing solution’s on varnished surfaces are too costly. Creating a window so as that area is not coated / varnished, to print barcode is better and easy solution. You may have to change art work of box OR carton & it’s approval process from various internal authorities / departments as well as buyers, may take months & printing cartons thereafter. Hence today if you plan for Track & Trace implementation in your company, actual smooth implementation across all your products may take 4-6 months.
 
Track & Trace solution provider selection is equally important. Single vendor solution who gives integrated solution of software, conveyor, printing, inspection, rejection, reporting and auditing should only be selected. Do not select different vendors for different process, as the key role is integrating different technologies and synchronizing them at each level. If your conveyor vendor, printer vendor, camera inspection vendor and software vendor are different, you will end up wasting huge amount of time and money. It’s better to pay penny more & get integrated solution from single vendor.
 
Track And Trace Technology
Hundreds of pharmaceutical machinery manufacturers are there and very few really have a capacity to integrate and synchronise technologies. Need of pharmaceutical companies is to integrate Track & Trace solution on existing packaging lines, very few machinery manufacturer has that experience. Vendors having rich experience of conveyor development and management, label printing solution as well as online inspection will only succeed in implementing integrated Track & Trace.
 
One should not believe in any vendor without having a demo of running your own cartons. All pharmaceutical companies have variety of boxes OR cartons in terms of shape, size, strength, material, etc. Track & Trace system machine should be capable to transport, print, inspect and reject your variety of boxes. Conveyor belt should be expandable and printing should be possible from sides, top, etc.
 
Varieties of industrial printers which can print barcodes at a required speed are available. Barcode print quality required by GS1 is D Grade. Human readable printed matter should be printed besides barcode. Camera inspection of printed barcode and human readable data is key challenge as online rejection system depends on camera inspection validation.
 
Better printing = Less Rejection = Less Re-packing exercise = Money Saved.
 
Camera Inspection system selection should be capable to run seamlessly at speed of 175 to 200 cartons per minute and synchronisation with online rejection system wherein rejected cartons are collected in separate locked rejection collection bin. Camera should inspect Barcode data, it’s grade, and each human readable matter like GTIN, Exp. Date, Batch No., UID (Unique Serial Number). Do Not ever think of dispatch without proper inspection of 2D barcode & human readable data, as doing so you are giving a chance of counterfeiting.
 
Networking across all packaging line to connect them to central server should be planned as Track & Trace Server should be able to communicate with computers on packaging lines. Track & Trace software and its database architecture plays key role in generating, managing as well as storing billions of unique serial data on to the server year after year. UID generation logic should be implemented in a way that it remains unique across all product platform and do not get repeated till six 6 months after expiry. UID gives key protection against counterfeiting and hence data should be stored in encrypted format in database. Mass Data Encryption should be adopted and data should be well protected using database security features by IT team.
 
Track & Trace software should have features to seamlessly import / export data between existing ERP/SAP as well as upload serialized data on to global server tomorrow. Batch wise / lot wise statistical reports, operator login wise performance, packaging line wise performance, product & product packaging line wise performance reports will help managers to take faster decisions. Easy Operation, Management and Maintenance of Track & Trace System along with rough & tough build are sure to give you better ROI.
 
Auditing features at each level are equally important and audit process should be defined to keep an eye on operations. Auditing may include, machine performance, printing performance and quality, inspection performance, rejection performance, machine speed performance, knowledge level of operators, etc.
 
Bar-coding and serialization as per GS1 standards is going to be life line of logistic management and hence will affect overall operation of pharmaceutical companies.
 
We are here to assist you for any queries related to Track & Trace. Feel free to contact us.
 
Lokesh Patel
Vice President (Track & Trace)
Aseptic Technology Inc.
NKP Pharma Group
Email : lokesh@aseptictechnology.com

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