Chris Siegele, Omega Design Corp.09.05.13
In the pharma industry, the fate of serialization legislation seems increasingly like a tiresome saga. One week track-and-trace (T&T) mandates are pending, and the next they’re not. State-level legislation is leading the industry forward, and then Congress mulls over separate supply chain security bills that would override state legislatures. Some people hope unit-level serialization will be excluded from any T&T law, while others see it as inevitable.
The industry is moving towards a more secure supply chain by improving product visibility during distribution. The collective decision to go ahead has been made; whether an act of Congress can unmake that decision remains to be seen. Meanwhile, much has been learned in the past decade from the sporadic yet encouraging progress towards a mature supply chain that utilizes all available data and technology. And as rolling mandates, benefits of enhanced serialization, and crucial economic factors of time-sensitive supply and demand all coalesce into the necessary energy to improve product visibility — the waiting game is a dangerous one indeed.
Time To Serialize
Consider, then, three important reasons why every pharma manufacturer should serialize now:
The U.S. is not alone in this endeavor. Turkey, China and the EU, among other governmental bodies, have forged ahead with their own pharma regulations. Forward-thinking manufacturers will develop smarter packaging lines to compete in an increasingly regulated environment. Simply maintaining traditional operations will no longer be sufficient in this new reality.
Try flipping through an industry trade magazine without being inundated with serialization messages; it’s almost impossible. The reason is that manufacturers are moving en masse to upgrade thousands of packaging lines around the world within a very compressed period of time. And even though there are a myriad of serialization solutions available, only a few offer the flexibility and scalability needed to work on a global level. This being the case, there is little doubt that the demand for high-quality serialization manufacturers, data management vendors, and system integrators will soon surpass the supply.
The FDA issued its final guidance to the industry in 2010. Since then, the pharma industry has rallied around the use of 2D data matrix codes to provide unit-level product visibility both during manufacturing and throughout the supply chain. Coding at the unit level — and communicating those codes to an MES or other data management system — is a technically challenging endeavor. To ensure the serialization process is reliable, manufacturers will require a cross-functional team focused on product handling, controls integration, line equipment, and data management software. The greatest industry demand will be for solution providers that offer expertise in these areas and have established working relationships with strategic partners.
Finally, delaying serialization will cost manufacturers ROI benefits. The need to serialize is not just about regulation. Serialization is about product visibility. Buried in the confusion and excitement surrounding serialization are many opportunities to gain competitive advantage. For instance, tracking product at the unit level will increase quality assurances and open channels to the end user like never before.
The fact is there is no more time left to wait. One must serialize now or risk losing market share within a few years.
Manual Case Packers for Efficiency
As the serialization market matures, common misconceptions are beginning to fade. It was once thought that expensive automatic case packers were a necessity for serialization. We can state with certainty that an automatic case packer is not a requirement for an effective serialization strategy. There are secure solutions available for manual and semi-automatic operations. In fact, the majority of manufacturers will likely adopt low-cost manual case packing solutions instead of higher-priced alternatives.
Serialization, in its simplest form, is about coding and verifying codes. If a product has a bad code, then reject the product. If a code doesn’t belong in a case, then replace the bad product or don’t let the case proceed. The print, label, vision, and reject capabilities to achieve serialization exist and have been in use on packaging lines for quite some time.
The challenge is to frame these capabilities together and to integrate them with data management software. Manufacturers can reduce this burden by being prepared with a detailed user requirement, including desired line speeds, code placement, container orientation, and case dimensions. With this, vendors can determine the appropriate degree of automation that will enable desired line speeds and overall efficiency.
Controls and software should take care of the serialization activities without disrupting operator workflow. Visual feedback systems and fail-safe conditions discreetly confine an operator to an “electronic path” until the operator satisfies the serialization requirements.
By taking this approach, the manual case-packing station becomes a semi-automated process, with the operator handing off some operations to automated systems. Ultimately, the collaboration between serialization vendors and end users will dictate the balance of automation needed to achieve desired line speeds while keeping down costs.
Aggregate Data after Aggregating Product
From a packaging perspective, there is a monumental risk with assuming that bottles will stay in the same sequence as they travel down a packaging line. All it takes is one misplaced bottle to disrupt the entire parent-child hierarchy in the database, which could undo days or weeks of production.
This is exactly what happened to a top five pharmaceutical manufacturer within two months of deploying its serialization solution based on upstream sequencing (FIFO or First In, First Out). Now this manufacturer is reconfiguring its serialization solution to a more secure method that doesn’t rely on bottle sequence. In hindsight, it wasn’t a matter of ‘if’ the sequence would foul up, but ‘when’.
The philosophy behind secure aggregation is to create physical aggregation prior to data aggregation. In other words, put the products into a bundle or case and then read the codes. This approach provides absolute certainty that the physical contents match the information in the serialized database.
A robust T&T system can provide information on individual units throughout the supply chain. Serialization partners should work together to bring the benefits of unit-level tracking into their packaging lines.
Waiting on Washington
Oops! The industry waited all spring and summer for Washington to come to some sort of conclusion on what a tracking system for prescription drugs would entail. It was supposed to be attached to a variety of bills, but ultimately never materialized. Some stakeholders expected federal pre-emption of the California law, which goes into effect in 16 months and has been the main driver in steering this nation toward a more secure supply chain.
The House of Representatives passed a version — legislation that would immediately weaken the supply chains in states where they were having the most issues by rendering state-specific laws mute. The Senate passed a different version — one that, at least, kept the requirement for product visibility throughout the supply chain intact, but put the mandate off to an undefined future date (reminding us of the Federal Prescription Drug Marketing Act of 1987, instructing the secretary to implement a T&T system). The differences were not reconciled prior to the House’s summer recess. Perhaps the situation was too much for Washington to handle.
On a local level, California legislators envisioned a way to secure their supply chain in 2004, and a superior model hasn’t been proposed in this country since. If everyone waited on Washington, there would have been no progress in the last decade while counterfeiters fine-tuned their operations.
Around the world, governments have made counterfeiters’ jobs tougher by implementing T&T regulations revolving around serializing and tracking drugs. Some go as far as tracking all the way to consumers (a hopeful future model for the domestic drug distribution system). Others have at least provided a first step in checking products at the point of dispense to ensure they came from a legitimate manufacturer.
As the laws stiffen around the world for inserting pharma products into the consumable supply, the U.S. is in the unfamiliar place of following leaders like Turkey, China and France on the subject. If the richest, most prolific healthcare economy wasn’t enough incentive for counterfeiters to insert their false product, the lack of supply chain controls — like knowing what products are where and when — could be seen as an enticing opportunity. Manufactures that waited hopefully for Washington to kill a full T&T system have gained nothing and lost precious time.
Act Now
California and global regulations will, ultimately, either cause manufacturers to comply or force them out of critical market share. No matter which path Washington eventually decides to traverse concerning serialization, the current ambiguity will end, sooner or later, with supply chain-strengthening mandates and firmer deadlines. That said, the sooner that manufacturers acknowledge this, the better positioned they will be to secure the high quality vendors needed to assist them with their serialization strategy.
Excessive cost is not a viable reason for further delay, as manufacturers with manual case packing operations can implement a secure serialization strategy without spending on an automatic case packer. Manufacturers would be well-advised to choose an approach that employs secure aggregation as opposed to upstream sequencing.
Meanwhile, enhanced serialization affords an opportunity for manufacturers to proactively secure supply chains in ways that will satisfy even a surprisingly strong mandate. In the process, they will gain insightful supply chain product visibility in the here and now, and the assurance of being prepared for the future.
Chris Siegele is a Serialization Specialist for Omega Design Corporation, a global provider of packaging solutions, specializing
in the design, manufacture, service, and support of container handling and packaging equipment systems. He can be reached at csiegele@omegadesign.com.
The industry is moving towards a more secure supply chain by improving product visibility during distribution. The collective decision to go ahead has been made; whether an act of Congress can unmake that decision remains to be seen. Meanwhile, much has been learned in the past decade from the sporadic yet encouraging progress towards a mature supply chain that utilizes all available data and technology. And as rolling mandates, benefits of enhanced serialization, and crucial economic factors of time-sensitive supply and demand all coalesce into the necessary energy to improve product visibility — the waiting game is a dangerous one indeed.
Time To Serialize
Consider, then, three important reasons why every pharma manufacturer should serialize now:
- California and international regulations are going into effect
- Serialization vendors have limited resource capacity to meet the impending demand surge
- Manufacturers can exploit the ROI benefits and competitive advantages that are inherent with unit level tracking.
The U.S. is not alone in this endeavor. Turkey, China and the EU, among other governmental bodies, have forged ahead with their own pharma regulations. Forward-thinking manufacturers will develop smarter packaging lines to compete in an increasingly regulated environment. Simply maintaining traditional operations will no longer be sufficient in this new reality.
Try flipping through an industry trade magazine without being inundated with serialization messages; it’s almost impossible. The reason is that manufacturers are moving en masse to upgrade thousands of packaging lines around the world within a very compressed period of time. And even though there are a myriad of serialization solutions available, only a few offer the flexibility and scalability needed to work on a global level. This being the case, there is little doubt that the demand for high-quality serialization manufacturers, data management vendors, and system integrators will soon surpass the supply.
The FDA issued its final guidance to the industry in 2010. Since then, the pharma industry has rallied around the use of 2D data matrix codes to provide unit-level product visibility both during manufacturing and throughout the supply chain. Coding at the unit level — and communicating those codes to an MES or other data management system — is a technically challenging endeavor. To ensure the serialization process is reliable, manufacturers will require a cross-functional team focused on product handling, controls integration, line equipment, and data management software. The greatest industry demand will be for solution providers that offer expertise in these areas and have established working relationships with strategic partners.
Finally, delaying serialization will cost manufacturers ROI benefits. The need to serialize is not just about regulation. Serialization is about product visibility. Buried in the confusion and excitement surrounding serialization are many opportunities to gain competitive advantage. For instance, tracking product at the unit level will increase quality assurances and open channels to the end user like never before.
The fact is there is no more time left to wait. One must serialize now or risk losing market share within a few years.
Manual Case Packers for Efficiency
As the serialization market matures, common misconceptions are beginning to fade. It was once thought that expensive automatic case packers were a necessity for serialization. We can state with certainty that an automatic case packer is not a requirement for an effective serialization strategy. There are secure solutions available for manual and semi-automatic operations. In fact, the majority of manufacturers will likely adopt low-cost manual case packing solutions instead of higher-priced alternatives.
Serialization, in its simplest form, is about coding and verifying codes. If a product has a bad code, then reject the product. If a code doesn’t belong in a case, then replace the bad product or don’t let the case proceed. The print, label, vision, and reject capabilities to achieve serialization exist and have been in use on packaging lines for quite some time.
The challenge is to frame these capabilities together and to integrate them with data management software. Manufacturers can reduce this burden by being prepared with a detailed user requirement, including desired line speeds, code placement, container orientation, and case dimensions. With this, vendors can determine the appropriate degree of automation that will enable desired line speeds and overall efficiency.
Controls and software should take care of the serialization activities without disrupting operator workflow. Visual feedback systems and fail-safe conditions discreetly confine an operator to an “electronic path” until the operator satisfies the serialization requirements.
By taking this approach, the manual case-packing station becomes a semi-automated process, with the operator handing off some operations to automated systems. Ultimately, the collaboration between serialization vendors and end users will dictate the balance of automation needed to achieve desired line speeds while keeping down costs.
Aggregate Data after Aggregating Product
From a packaging perspective, there is a monumental risk with assuming that bottles will stay in the same sequence as they travel down a packaging line. All it takes is one misplaced bottle to disrupt the entire parent-child hierarchy in the database, which could undo days or weeks of production.
This is exactly what happened to a top five pharmaceutical manufacturer within two months of deploying its serialization solution based on upstream sequencing (FIFO or First In, First Out). Now this manufacturer is reconfiguring its serialization solution to a more secure method that doesn’t rely on bottle sequence. In hindsight, it wasn’t a matter of ‘if’ the sequence would foul up, but ‘when’.
The philosophy behind secure aggregation is to create physical aggregation prior to data aggregation. In other words, put the products into a bundle or case and then read the codes. This approach provides absolute certainty that the physical contents match the information in the serialized database.
A robust T&T system can provide information on individual units throughout the supply chain. Serialization partners should work together to bring the benefits of unit-level tracking into their packaging lines.
Waiting on Washington
Oops! The industry waited all spring and summer for Washington to come to some sort of conclusion on what a tracking system for prescription drugs would entail. It was supposed to be attached to a variety of bills, but ultimately never materialized. Some stakeholders expected federal pre-emption of the California law, which goes into effect in 16 months and has been the main driver in steering this nation toward a more secure supply chain.
The House of Representatives passed a version — legislation that would immediately weaken the supply chains in states where they were having the most issues by rendering state-specific laws mute. The Senate passed a different version — one that, at least, kept the requirement for product visibility throughout the supply chain intact, but put the mandate off to an undefined future date (reminding us of the Federal Prescription Drug Marketing Act of 1987, instructing the secretary to implement a T&T system). The differences were not reconciled prior to the House’s summer recess. Perhaps the situation was too much for Washington to handle.
On a local level, California legislators envisioned a way to secure their supply chain in 2004, and a superior model hasn’t been proposed in this country since. If everyone waited on Washington, there would have been no progress in the last decade while counterfeiters fine-tuned their operations.
Around the world, governments have made counterfeiters’ jobs tougher by implementing T&T regulations revolving around serializing and tracking drugs. Some go as far as tracking all the way to consumers (a hopeful future model for the domestic drug distribution system). Others have at least provided a first step in checking products at the point of dispense to ensure they came from a legitimate manufacturer.
As the laws stiffen around the world for inserting pharma products into the consumable supply, the U.S. is in the unfamiliar place of following leaders like Turkey, China and France on the subject. If the richest, most prolific healthcare economy wasn’t enough incentive for counterfeiters to insert their false product, the lack of supply chain controls — like knowing what products are where and when — could be seen as an enticing opportunity. Manufactures that waited hopefully for Washington to kill a full T&T system have gained nothing and lost precious time.
Act Now
California and global regulations will, ultimately, either cause manufacturers to comply or force them out of critical market share. No matter which path Washington eventually decides to traverse concerning serialization, the current ambiguity will end, sooner or later, with supply chain-strengthening mandates and firmer deadlines. That said, the sooner that manufacturers acknowledge this, the better positioned they will be to secure the high quality vendors needed to assist them with their serialization strategy.
Excessive cost is not a viable reason for further delay, as manufacturers with manual case packing operations can implement a secure serialization strategy without spending on an automatic case packer. Manufacturers would be well-advised to choose an approach that employs secure aggregation as opposed to upstream sequencing.
Meanwhile, enhanced serialization affords an opportunity for manufacturers to proactively secure supply chains in ways that will satisfy even a surprisingly strong mandate. In the process, they will gain insightful supply chain product visibility in the here and now, and the assurance of being prepared for the future.
Chris Siegele is a Serialization Specialist for Omega Design Corporation, a global provider of packaging solutions, specializing
in the design, manufacture, service, and support of container handling and packaging equipment systems. He can be reached at csiegele@omegadesign.com.