The objective of global track and trace regulations is to protect patient safety by preventing counterfeit, diversion of products and to ensure product integrity across the complete pharma supply chain. Shaunak J Dave, Asian Market Director, Optel Vision, feels that this is a very significant challenge for Indian pharma industry having positioned itself as the global pharma manufacturing hub. This article gives insights on the present implementation challenges in the Indian context on how to select a reliable vendor with cost-effective India-centric solution to meet compliance and ensure business continuity and growth
In 2010, while talking to a prospective customer and trying to understand his needs, I was told: ‘Mujhe to 2D print karna hai, bas! Nothing Else’
Industry transformation on track and trace: Then and now
At that time, serialisation was all about tertiary, i.e. offline printing shipper (case) label, which could be done by buying a thermal transfer desktop printer and one scanner, using it offline and catering to multiple packaging lines. Later, it was extended to secondary, i.e. adding an offline carton printing and inspection station to overprint 2D Data Matrix codes and human-readable characters (GTIN, batch numbers, expiry dates and serial numbers) on cartons (secondary packaging). The project was considered a packaging development project, and only one of two functional teams were involved.
But now, in 2016, what we have experienced is a huge paradigm shift. The knowledge of subject matter and approaches have drastically changed, compared to what they were in 2010. Thanks to our Indian mindset to learn continuously with global perspective and evolve with the times, the industry has realised that over-printing is just tip of the iceberg and started seeing what is underneath.
Six years ago, the industry was talking about batch- specific serialisation (French Regulation – CIP 13), but now, it’s all about the challenges of aggregation on packaging lines, total track and trace architecture, scalability (to handle big volumes of serialisation/ aggregation/ transaction data across the supply chain network and rapid information exchange with trade partners, CMO and government efficiently) and, of course, the data integrity. The shift is clear whenever we meet any company where previously only a few people were involved in the project. And now, there are cross-functional teams consisting of production, packaging, validation, QA, IT, project management, regulatory, engineering and sales to meet the challenges of this complex compliance. We have experienced the noticeable attention from top management, as non-compliance means business loss.
However, aggregation is still undergoing a learning curve!
The Indian pharma industry has realised why leading global brands have made massive investments in this programme and has tried to understand their experiences and learnings, thus creating an Indian model of project implementation in a cost-effective way.
The objective of global track and trace is to fight against counterfeiting to protect patient safety, prevent deviations, and ensure product integrity across the total supply chain. However, there is still a lot of work to be done, on global scale and collectively, to attain that sublime objective.
Lao Tzu once said, “The journey of a thousand miles begins with one step. This is just the beginning!
Challenges of global track and trace for Indian pharma industry
As we all are aware, track and trace regulations will cover more than 75 per cent of the global medicine supply by 2018/2019. Non-compliance of those regulations results in restrictions on market entry, which means business loss; and any false instance (false printing, missing printing, incorrect data etc.) would lead to penalties and product recalls. This challenge is becoming highly complex and critical for the Indian pharma industry, which exports to almost 200 countries around the world.
The Indian industry has been realising the extent of challenges like:
Diverse regulations: USA_ DSCSA, EU FMD, India, China, Brazil, Turkey, Argentina, Saudi Arabia, Korea and the list goes on. The biggest challenge for Indian manufacturers is to have one common solution that can meet their present needs and have the scalability to meet future requirements.
Different standards (GS1/ non-GS1) and interpretations: Most countries have adopted GS1-based standards, but some have adopted non-GS1 standards. There are several data structures and communication protocols for data exchange that are yet to be standardised.
Moving timelines: The industry has experienced moving timelines for various regulations. This demands flexibility and quick adaptability to the situation in order to manoeuvre serialisation programmes with agility.
Artwork modification: Before the serialisation era, the overprinting was limited to batch numbers and expiry dates. But now, 2D + GTIN, batch numbers, expiry dates and unique serial numbers are required. If sufficient space is not available, either the packaging needs to be modified or the overprinting space has to be changed to a different plane of packaging. Aggregation also has an impact on artwork modification.
Integration with existing packaging-line equipment
Indian manufacturing companies have been using a wide variety of equipment — many brands, starting from top-end packaging machinery from Germany, to low-cost machinery from China. Integrating serialisation systems with existing equipment (especially with cartoner, labeller and case packer) and using existing printers (of course, it has to be serialisation-compatible) is very challenging.
Space constraints on production floor: Almost all the old plants have space constraints for additional serialisation/aggregation equipment. The biggest challenge is to select the best possible equipment and process, while minimising minimum line extensions. The latest trend is to build an integrated system that includes a checkweigher, TE labelling and carton printing, and inspection in the same machine, and/ or minimise the carton print and inspection system as much as possible.
Multiple packaging configurations on the same line: Unlike the US and the EU, Indian companies have been utilising manual packaging lines, so that multiple packaging can be produced, and small lots can be supplied to export markets very quickly. Very few lines are dedicated to one product, and frequent product changeover is observed. With the introduction of serialisation and aggregation equipment, the line start-up time has also increased. With multiple packaging running on the same line, it further increases the complexity of aggregation.
IT architecture and infrastructure: Is it better to go for L2 (Line), L3 (Plant), L4 (Corporate), or L2 to L4? This demands a lot of deliberations and multiple considerations. Another question is whether to go for an on-site solution or cloud-based solution. How can WH processes be integrated with enterprise-level serialisation servers and, most importantly, will the infrastructure be able to handle the storage of billions of EPC events, secure data exchange (from server to line and back, as well as with trading partners and government), operate with minimum down time, ensuring zero per cent data loss.
All computer-based systems work on the same principle: Garbage In – Garbage Out.
If the generation of the data at the packaging line is not reliable and incorrect, the same will be exchanged and communicated across the partners and government.
Aggregation: While implementing aggregation, the biggest challenge is the compromise of line efficiency. The selection of the right aggregation method also depends upon the line equipment, and the existing packaging process and configuration. Which is the appropriate method, ‘pack and scan’ or ‘scan and pack’? This is a very relevant question, and if the appropriate aggregation method is not chosen, it may significantly impact line efficiency. It has been also noticed in the industry that an improper selection on the right aggregation process resulted in a production loss of almost 30 per cent.
Multiple line-level solution providers and vendor-locking architecture: Most of the companies in India have been working with more than one packaging line vendor within a single plant or in different plants. This also imposes significant challenges for IT enterprise track and trace vendor integration. If the existing supplier’s architecture is vendor-locking (cannot accommodate any other IT vendor or line vendor, etc.), this would be a significant issue.
Implementation cost: India is considered a low-cost production hub for generics. Complying with those serialisation regulations further adds to the cost of production. To deploy the right solution in a cost-effective way is one of the biggest challenges.
Regulatory compliance and data integrity: It’s quite simple. Global track and trace is a compliance issue, and failure to do so will severely impact business. There is no escape, no compromise. The game in regulatory markets is completely different than in emerging markets.
Serialisation and aggregation is an integral part of your secondary packaging line. Imagine if during the packaging, the equipment fails (duplicate serial numbers printed and accepted or hard drive gets corrupted and data lost). What could be the impact? Rejection, rework or maybe even product recalls. This would cost you millions of dollars.
Time: Only a few months left for USA – DSCSA and EU – FMD, the level of challenges has escalated considerably with the enormous pressure of timelines when it comes to line-level implementation. Typically, full line implementation takes at least six months (project start-up, documentation like FS, DS, manufacturing, FAT, SAT and validation), and due to the high volume of business, major solution providers also find it difficult to improve the delivery timeline.
The India-specific solution
The Indian pharma industry’s manufacturing spectrum is very vast, ranging from very small, single-line units supplying to domestic markets, to multiple highly sophisticated high-speed lines exporting to global markets. This demands multiple solutions with differential pricing, which must be fit for the purpose. The right solution for one company can be proven wrong for another. However, the following can be common factors to help select an effective solution.
Modular: The solution can be implemented in various modules and easily integrated on the packaging lines. Solutions can be designed in such a way that it can also be implemented in phases.
Scalable: If a customer wants a solution to meet the regulations of only a few countries today, later on, the same system must be capable to meet other countries’ regulations without major impact on packaging line and the cost. For example, if the solution is deployed to meet India DGFT regulation, the same solution should work for EU FMD or USA – DSCSA compliance without a major change in hardware and software plus at minimum cost.
Flexible and adaptable: The solution should be flexible enough to accommodate any type of packaging line and any type of packaging configuration and adaptable to customer-specific product processes (like IPQC etc.), easy integration with line machinery, and work with any leading OEM partners, ERP/MES and IT solution provider and vice versa.
Open end/ non-vendor-locking: The solution should work with any line, IT solution provider or printer suppliers of customer’s preferred choice, and it should be easily integrated. Vendor-locking architectures or suppliers are highly dangerous, as they lead to high costs at later stages.
Versatile: The solution should be designed in such a way that it addresses one problem with many approaches. It must address the various types of lines, products, packaging, speed and aggregation patterns. Capability to meet various global serialisation regulation requirements must also be considered.
Reliable: Imagine your business is volume-driven and your packaging lines run 24/7. If a small problem occurs in the serialisation system, it may result in significant down time and production loss. Therefore, the selected solution must be highly reliable (as bypass mode is no longer accepted).
Easy to operate: Most of the packaging lines are running with contractual employees who are not high skilled engineers. The system must be easy to operate and ergonomically designed. Otherwise, problems will occur during productivity ramp-up, leading to breakdowns and rework.
Cost-effective: If the system is not cost-effective, it will affect the company’s business model, resulting in higher production costs and thus impacting profitability. Deciding between a system that is ‘costly, but reliable’ and one that provides good ‘value for money’ is very critical. When there is a question of compliance and business continuity, the question of pricing is secondary. The first question must be whether the vendors and selected solutions are capable of meeting current and future requirements? Does it deliver the right value to enhance present business? What would be the ROI? Only then, one should think of optimising the solution to make it more cost-effective.
Everybody is a genius. But if you judge a fish by its ability to climb a tree, it will live its whole life believing that it is stupid
– Albert Einsten
Product seller or solution provider: There is a clear distinction between a long-term solution partner and a product seller. Global track and trace is a very complex, long term, multifunctional project with limited clarity on what to do and how to do it. The solution provider must have strong and robust internal quality processes, unmatched experience in the field and working with global regulatory authorities to develop an effective solution. One size does not fit all, as this would be a fatal approach for serialisation.
Global track and trace experience: There is also a huge difference between an ‘available solution’ and the ‘we shall develop for you’ approach. Proven solution providers assure you peace of mind by eliminating trial and error, and the success factor is really high. Often, people fail to understand the real cost of trial and error on the commercial packaging lines and are more inclined to save on initial capital investment. Has this vendor implemented end-to-end solution? How many partners do they work with? How many total solutions deployed? etc. Asking for customer references and visiting them to see the production line in operation will give you a fair idea and learning opportunity from that reference.
Local support and adaptability: Track and trace is a new technology platform and a big change for production and engineering staff. Absence of adequate training and continuous support will lead to loss of productivity and more downtime due to rejection and rework. Prompt services by qualified support staff of solution provider is a key factor to ensure smooth running of lines post – implementation. If the solution is not adaptable to one’s production process, not in line with your validation criteria, then it will increase the chances of project delays and revalidation.
Optel Vision was selected by a global MNC in India because it demonstrated its proven global experience, local reach and adaptability to their manual packaging lines, running with multiple configurations. A totally customised approach is inevitable to be successful in this kind of environment rather than offering some stand – alone machines!
Financial capability: This project is long-term in nature, and it may take many years for full deployment. If your vendor is not financially capable, you are taking a great risk when you invest millions of dollars in this solution.
The first step toward success is taken when you refuse to be a captive of the environment in which you first find yourself
– Mark Caine
The best approach to evaluate a vendor in totality
Engineering assessment: Let the vendor do the engineering assessment of your production lines and understand your requirements. Then ask him to offer multiple solution scenarios with respect to cost and risk. 50 per cent of the vendors shall be screened during this exercise.
How you can assess the reliability of vendor? The answer is: See yourself, feel yourself and believe yourself.
Facility visit and vendor audit: For the large multi-locations projects, it is essential to visit the vendor’s production facility and meet experts to understand how they work. Also perform a quality audit of their systems and processes.
Reference check: Visit at least four to five different customers where they implemented their solutions and check the reliability, flexibility, adaptability of the solution.
Techno-commercial evaluation (based on TCO): Since track and trace is a relatively new platform entailing the amalgamation of various technologies, the total landscape is not entirely visible. Often, the evaluation is done comparing existing vision and printing technologies available in the plant, but global track and trace goes far beyond existing technologies!
It is better to learn from someone’s experience than to learn hard way. If the wrong system was selected, then the company needs to ‘manage’ different ways to run that system.
The other tool available for comprehensive commercial evaluation is the TCO.
The TCO perspective: What we see is often just a fraction of reality
TCO comprises initial capital investment (direct and indirect costs), operation costs, service and maintenance costs, as well as hidden costs.
Direct cost: This is often mentioned in the service provider (vendor) quote and includes things like hardware, software, integration, validation, documentation and FAT/SAT.
Ideally, the quote must also include new OEM equipment (printers, case packers, print and apply, etc.), print layout software and layout preparation, additional conveyors, mounting, guides, brackets, signal exchange with existing PLC, validation documents and execution assistance, training assistance, shipping costs, etc.
Many times, it has been observed that some vendors keep their initial offer very low and later, during the project execution phase, the customer is forced to pay more (as common level of understanding was deliberately not achieved).
Indirect costs: This is the cost which involves the internal resources of the organisation, like project management, validation execution, IT Integration, training, line modifications/ redesig, electrical wiring, network connections etc.
Hidden costs: This includes expenses related to acquisition/ purchase, set-up, change management, infrastructure support, electronic security, rejection and rework, product recalls, line breakdown/ shutdown, line efficiency drop, etc.
Track and trace is a business decision of a strategic nature. The project/ purchase department must work with the cross-functional team to evaluate TCO rather than focusing only on initial capital investment and maximising discount. If the vendor offers a huge discount, it means either they do not believe in ethical business practices or are cutting corners.
One customer told me, “If the chosen solution saves my four days of production shutdown annually, in spite of the high capital investment, the ROI is achieved in a year.” We all know what does it cost us if a line shuts down, or if there is a high rejection and rework rate.
Pilot deployment: In general, compliance timelines are really short (a few regulations are already in effect and some are on the verge), but if you have sufficient time it is strongly recommended to go for a pilot line with one or two vendors and from there evaluate further which can be your long – term track and trace partner.
Global track and trace is highly complex in nature and the success mantra is: Understand what it is, where you are, what you need, involve all necessary functions, evaluate vendors with TCO analysis, build long-term relationship with your solution partner, and take joint responsibility as a team to make this project successful.
The countdown has begun, if you aim for global business, serialisation is a must. The earlier, the better.
Have a bias toward action; let’s see something happen now. You can break that big plan into small steps and take the first step right away
– Indira Gandhi
Shaunak J Dave can be reached at [email protected]