John Jordon and Vito Pirrera, Vantage Consulting Group03.07.17
DSCSA. It stands for the Drug Supply Chain Security Act, but if you’re a contract manufacturing organization (CMO) who has procrastinated, it means something along the lines of doomed, scared, cramming and scrambling around.
DSCSA is the FDA regulation requiring pharma companies to begin “serializing” all prescription drug products intended for distribution to the U.S. market. That means printing each saleable unit—think carton, tray and individual bottles—and homogeneous shipper (case) with a unique identifier, starting Nov. 27, 2017, at the latest.
Serialization is one of the first steps toward making every capsule, vial, tablet or strip traceable through the pharmaceutical supply chain—from origin to destination, whether it’s the drug store or doctor’s office. It’s the first stage of developing a system that will help regulators protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
A great many pharmaceutical manufacturers, CMOs and contract packaging organizations (CPOs) have re-engineered their operations to comply with the regulation. But as it was in high school, a few have not completed the homework, and they’re sweating bullets.
A common question is, “I haven’t started serializing, is it too late?” The answer depends on how you think about it. There’s a compliance perspective and a business perspective. Let’s parse them out.
From the legal perspective, what are the consequences of missing the deadline? Will there be fines? Sanctions? Extensions? No one but the FDA is qualified to answer, so let’s set those questions aside for now.
Now a question for you: What is the business impact if your clients elect to avoid dealing with a contract manufacturer who is clearly missing the DSCSA deadline? Potentially catastrophic, we’d guess.
So there really is no too late. If DSCSA applies to you and you’re not on track, start now. The good news is that all is not lost. If you get started on your serialization implementation today and make a good faith effort, it’s reasonable to expect you can get a packaging line, perhaps more, fully serialized by the end of November.
This article lays out a strategy for tackling the problem. Although you may be panicking, it doesn’t include a panic stage. That’s not going to speed things up.
Understand the law
First, let’s admit DSCSA is complex and opaque and clarify exactly what the law requires that you, the contract manufacturer, complete by Nov. 27, 2017. The requirements are probably less onerous than you think. There are two key items that need to be implemented by Nov. 27, 2017:
That’s the law, but there might be some wiggle room here. Consider this provision: Not until Nov. 27, 2019, will wholesalers be required to trade only products that have been serialized. This implies that if there’s non-serialized inventory in the supply chain, with a date of manufacture prior to Nov. 27, 2017, it will not need to be serialized. On the other hand, wholesalers will need a connection between the saleable unit and case level ID before very long to ensure they’re complying with the law.
Now let’s return the original question. If you haven’t started your serialization program, are you behind the eight-ball? Yes. Is it a crisis? Hard to tell. Now that you understand the law, just get started.
Assign a serialization team
To get started, first commission a fast-track serialization team. Assign members of your operation who are involved in business strategy, finance, labeling, operations, manufacturing, engineering, IT infrastructure, regulatory affairs, sales, marketing and supply chain management. Give them a clear mission statement: Do what needs to be done to preserve our business, meet the regulatory requirements at the very least, do so efficiently, and, if possible, set ourselves up for new capacity and quality down the road.
Scope out the challenge
Again the prevailing question is, is it too late? Now that you know the law and who’s in charge of getting you to compliance—the Fast-Track Serialization Team—we further refine the question. Too late for what and in whose view?
To answer, go over your internal business considerations around DCSCA compliance. Your goal is to better grasp what you need to do next and how fast.
For example, if you’re a CMO, whether you’re late or not really depends on what your clients need from you in terms of serialization and when they need it. More on that in a minute.
Another concern is your company’s investment philosophy. How exactly are you profiting by scrambling to service the customers for whom serialization is the most important? The answer will determine where and how you prioritize upgrades and reengineering.
Then there are distributor requests. What are they asking of you? Distributors have a requirement for 2019—trading products with unique identifiers—and may want some idea whether they’re going to make the deadline with you as a partner.
Finally, what are your own infrastructure capabilities for getting this done? In other words, how hard is this going to be? And is fast-tracking serialization worth the extra cost and headaches? Absolutely, if you decide it’s important to remain in the business of manufacturing prescription drugs.
Drilling these questions in your mind should be helping you bring your challenge into crisper focus. But you’re still not done with your problem statement.
As mentioned above, you need to have one more set of conversations to get further insight. You need to speak directly with your clients about some practical implications of DSCSA.
Talk with your clients
First, ask them directly: Do they need to aggregate, or would serialization alone be enough for the time being? As mentioned in above, you’re not technically required to aggregate by the Nov. 27, 2017, deadline. That is, you don’t need labels on cases and pallets to “know” what serial numbers are inside them. But your customers might want you to be able to do that now. So ask, “Can we live with just serializing to start?” Then again, if you have the resources and wherewithal, maybe you should go ahead and include aggregation in your project now.
Data management is another key discussion point you need to take up with your clients. Does the customer want you to serialize and manage all the data for those products, packages and other saleable units? Or do they just want to see the numbers? Or do they want a lot of sophistication, e.g., a data transfer process between your systems and theirs?
Another question: Does your customer want to give you the numbers that you’ll be applying to the product, or does the customer want you to generate the numbers yourself? How will they need to exchange that information?
So as you can see, the question if it’s too late is largely a semantic one. Whether you’re ready or not for the Nov. 27, 2017, DSCSA deadline triggers the question, what does ready mean to you and your clients?
Fortunately, that hard question has a simple, familiar answer: Just start now and dive in. With these conversations settled, you should be able to plunge into the work with confidence.
Ultimately, you’ll need master planning, system integration and new technology implementation. If you need help, serialization consultants are available who can transform a production line or two between today and Nov. 27, 2017. As you choose a vendor, make them prove they can save you money over competitors, execute faster, and minimize your downtime.
Most CMOs hire a consulting partner and serialization vendors after initiating their project internally. Whether you do that and whenever you do that, the initial stages of a systematic project should look something like the following:
Scope definition. Formalize the scope of your project based on the early work of the Fast-Track Serialization Team and conversations you’ve had to date. Define in writing the program requirements in terms of how many lines you’ll be transforming, the clients you’ll be exchanging data with, the labeling scheme you have in mind, and the warehouse flows.
Level 4 scope definition. A major piece of project planning is getting a grasp of the “Level 4” data considerations. Level 4 refers to the integration of the plant floor systems with existing corporate IT systems that run manufacturing and now need to be upgraded to handle serial number management and reporting requirements—Level 4 or L4 systems are shorthand for their place in the hierarchy of IT solutions.
Integrating the packaging line with Level 4 data makes it subject to every quirk and blip that can occur on the corporate network, any of which can potentially shut down the serialization system and the production line. Historically, a typical glitch or malfunction in a corporate manufacturing program such as SAP or Oracle would not normally affect plant floor production. This is because the software modules usually do not interact on a real-time basis with manufacturing systems—process and packaging. Process control systems and packaging automation are designed to function regardless of what happens to the plant’s SAP system for instance.
Team definition and gap identification. If you have created a Fast-Track Serialization Team, it’s worth making it official and having the teammates commit to the full seven- or eight-month project. If you have a consultant, they should join the team, clarifying with you the recommended serialization program, team roles, headcount duration of responsibility, restrictions, priorities and availability. The partner might suggest a new member or two to fill gaps or trim redundant members.
As Is/To Be. Here you’ll go deeper with scope definition, performing an “As-Is/To-Be” analysis intended to clearly document all project efforts to date and highlight any potential gaps within the scoped engagement. Detail proposals for line designs and layouts, products by line, project plans and IT infrastructure if any.
Packaging line impact analysis. Now you’ll make the plan visual, creating a summary document showing changes by packaging line with “to be” diagrams defining planned technology to support the changes. All impacted lines should be included. Engineering and manufacturing personnel familiar with the lines and their operations should be asked to carefully review their current and future state. Input from every trusted decision-maker should be encouraged and considered. Deliberately assess the high-level strategic business ramifications of operational changes.
Project capital cost review and recommendations. Now it’s time to create a Capital Estimate Document including complete cost estimate by project phase, with a +/- 20% accuracy. The estimates should include engineering, equipment, commissioning/validation and continued support. At this stage, ensure proposed equipment choices are consistent with design choices to date.
Vendor and solution definition(s). Based on current status, systems and program objectives, it’s time to choose potential vendors and define their possible scope of work. Based on your current status, objectives and available personnel, review overall resource requirements for the program to identify limitations and gaps. Consider installed solutions and positive or negative experience with all potential vendors.
Detail requirements and documentation. Plan to have a well-defined user requirement specification (URS), functional requirement specification (FRS) and request for proposal (RFP). You’ll need to define approaches for factory acceptance testing (FAT), site acceptance testing (SAT) and validation processes—installation qualification, operational qualification and performance qualification documents. You’ll also need to review existing standard operating procedures (SOPs) and make modifications to reflect the serialized state of the packaging floor. You may even have to develop new SOPs.
Training. With all of the previous planning steps spelled out and the vendor starting to implement according to plan (fingers crossed), this is the final step in preparing to become fully operational and fully compliant with this stage of DSCSA requirements.
If you’re just starting to focus on DSCSA now, these are the steps you need to take to go from panic to performance in complying with the Nov. 27, 2017 round of regulations. Although it’s not too late, remember, there is no too late. There’s no time left for procrastination.
John Jordon, P.E., is vice president of business strategies at Vantage Consulting Group.
Vito Pirrera is executive vice president of operations at Vantage Consulting Group.
DSCSA is the FDA regulation requiring pharma companies to begin “serializing” all prescription drug products intended for distribution to the U.S. market. That means printing each saleable unit—think carton, tray and individual bottles—and homogeneous shipper (case) with a unique identifier, starting Nov. 27, 2017, at the latest.
Serialization is one of the first steps toward making every capsule, vial, tablet or strip traceable through the pharmaceutical supply chain—from origin to destination, whether it’s the drug store or doctor’s office. It’s the first stage of developing a system that will help regulators protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
A great many pharmaceutical manufacturers, CMOs and contract packaging organizations (CPOs) have re-engineered their operations to comply with the regulation. But as it was in high school, a few have not completed the homework, and they’re sweating bullets.
A common question is, “I haven’t started serializing, is it too late?” The answer depends on how you think about it. There’s a compliance perspective and a business perspective. Let’s parse them out.
From the legal perspective, what are the consequences of missing the deadline? Will there be fines? Sanctions? Extensions? No one but the FDA is qualified to answer, so let’s set those questions aside for now.
Now a question for you: What is the business impact if your clients elect to avoid dealing with a contract manufacturer who is clearly missing the DSCSA deadline? Potentially catastrophic, we’d guess.
So there really is no too late. If DSCSA applies to you and you’re not on track, start now. The good news is that all is not lost. If you get started on your serialization implementation today and make a good faith effort, it’s reasonable to expect you can get a packaging line, perhaps more, fully serialized by the end of November.
This article lays out a strategy for tackling the problem. Although you may be panicking, it doesn’t include a panic stage. That’s not going to speed things up.
Understand the law
First, let’s admit DSCSA is complex and opaque and clarify exactly what the law requires that you, the contract manufacturer, complete by Nov. 27, 2017. The requirements are probably less onerous than you think. There are two key items that need to be implemented by Nov. 27, 2017:
- You need to apply unique serial numbers using 2D barcodes to all saleable units (e.g., the lowest saleable level); and
- You need to apply unique serial numbers using 2D or linear barcodes to homogeneous cases. Note: you do not have to aggregate yet. That is, your IT system doesn’t have to “know” what’s in the case and connect products in the case with the case number.
That’s the law, but there might be some wiggle room here. Consider this provision: Not until Nov. 27, 2019, will wholesalers be required to trade only products that have been serialized. This implies that if there’s non-serialized inventory in the supply chain, with a date of manufacture prior to Nov. 27, 2017, it will not need to be serialized. On the other hand, wholesalers will need a connection between the saleable unit and case level ID before very long to ensure they’re complying with the law.
Now let’s return the original question. If you haven’t started your serialization program, are you behind the eight-ball? Yes. Is it a crisis? Hard to tell. Now that you understand the law, just get started.
Assign a serialization team
To get started, first commission a fast-track serialization team. Assign members of your operation who are involved in business strategy, finance, labeling, operations, manufacturing, engineering, IT infrastructure, regulatory affairs, sales, marketing and supply chain management. Give them a clear mission statement: Do what needs to be done to preserve our business, meet the regulatory requirements at the very least, do so efficiently, and, if possible, set ourselves up for new capacity and quality down the road.
Scope out the challenge
Again the prevailing question is, is it too late? Now that you know the law and who’s in charge of getting you to compliance—the Fast-Track Serialization Team—we further refine the question. Too late for what and in whose view?
To answer, go over your internal business considerations around DCSCA compliance. Your goal is to better grasp what you need to do next and how fast.
For example, if you’re a CMO, whether you’re late or not really depends on what your clients need from you in terms of serialization and when they need it. More on that in a minute.
Another concern is your company’s investment philosophy. How exactly are you profiting by scrambling to service the customers for whom serialization is the most important? The answer will determine where and how you prioritize upgrades and reengineering.
Then there are distributor requests. What are they asking of you? Distributors have a requirement for 2019—trading products with unique identifiers—and may want some idea whether they’re going to make the deadline with you as a partner.
Finally, what are your own infrastructure capabilities for getting this done? In other words, how hard is this going to be? And is fast-tracking serialization worth the extra cost and headaches? Absolutely, if you decide it’s important to remain in the business of manufacturing prescription drugs.
Drilling these questions in your mind should be helping you bring your challenge into crisper focus. But you’re still not done with your problem statement.
As mentioned above, you need to have one more set of conversations to get further insight. You need to speak directly with your clients about some practical implications of DSCSA.
Talk with your clients
First, ask them directly: Do they need to aggregate, or would serialization alone be enough for the time being? As mentioned in above, you’re not technically required to aggregate by the Nov. 27, 2017, deadline. That is, you don’t need labels on cases and pallets to “know” what serial numbers are inside them. But your customers might want you to be able to do that now. So ask, “Can we live with just serializing to start?” Then again, if you have the resources and wherewithal, maybe you should go ahead and include aggregation in your project now.
Data management is another key discussion point you need to take up with your clients. Does the customer want you to serialize and manage all the data for those products, packages and other saleable units? Or do they just want to see the numbers? Or do they want a lot of sophistication, e.g., a data transfer process between your systems and theirs?
Another question: Does your customer want to give you the numbers that you’ll be applying to the product, or does the customer want you to generate the numbers yourself? How will they need to exchange that information?
So as you can see, the question if it’s too late is largely a semantic one. Whether you’re ready or not for the Nov. 27, 2017, DSCSA deadline triggers the question, what does ready mean to you and your clients?
Fortunately, that hard question has a simple, familiar answer: Just start now and dive in. With these conversations settled, you should be able to plunge into the work with confidence.
Ultimately, you’ll need master planning, system integration and new technology implementation. If you need help, serialization consultants are available who can transform a production line or two between today and Nov. 27, 2017. As you choose a vendor, make them prove they can save you money over competitors, execute faster, and minimize your downtime.
Most CMOs hire a consulting partner and serialization vendors after initiating their project internally. Whether you do that and whenever you do that, the initial stages of a systematic project should look something like the following:
Scope definition. Formalize the scope of your project based on the early work of the Fast-Track Serialization Team and conversations you’ve had to date. Define in writing the program requirements in terms of how many lines you’ll be transforming, the clients you’ll be exchanging data with, the labeling scheme you have in mind, and the warehouse flows.
Level 4 scope definition. A major piece of project planning is getting a grasp of the “Level 4” data considerations. Level 4 refers to the integration of the plant floor systems with existing corporate IT systems that run manufacturing and now need to be upgraded to handle serial number management and reporting requirements—Level 4 or L4 systems are shorthand for their place in the hierarchy of IT solutions.
Integrating the packaging line with Level 4 data makes it subject to every quirk and blip that can occur on the corporate network, any of which can potentially shut down the serialization system and the production line. Historically, a typical glitch or malfunction in a corporate manufacturing program such as SAP or Oracle would not normally affect plant floor production. This is because the software modules usually do not interact on a real-time basis with manufacturing systems—process and packaging. Process control systems and packaging automation are designed to function regardless of what happens to the plant’s SAP system for instance.
Team definition and gap identification. If you have created a Fast-Track Serialization Team, it’s worth making it official and having the teammates commit to the full seven- or eight-month project. If you have a consultant, they should join the team, clarifying with you the recommended serialization program, team roles, headcount duration of responsibility, restrictions, priorities and availability. The partner might suggest a new member or two to fill gaps or trim redundant members.
As Is/To Be. Here you’ll go deeper with scope definition, performing an “As-Is/To-Be” analysis intended to clearly document all project efforts to date and highlight any potential gaps within the scoped engagement. Detail proposals for line designs and layouts, products by line, project plans and IT infrastructure if any.
Packaging line impact analysis. Now you’ll make the plan visual, creating a summary document showing changes by packaging line with “to be” diagrams defining planned technology to support the changes. All impacted lines should be included. Engineering and manufacturing personnel familiar with the lines and their operations should be asked to carefully review their current and future state. Input from every trusted decision-maker should be encouraged and considered. Deliberately assess the high-level strategic business ramifications of operational changes.
Project capital cost review and recommendations. Now it’s time to create a Capital Estimate Document including complete cost estimate by project phase, with a +/- 20% accuracy. The estimates should include engineering, equipment, commissioning/validation and continued support. At this stage, ensure proposed equipment choices are consistent with design choices to date.
Vendor and solution definition(s). Based on current status, systems and program objectives, it’s time to choose potential vendors and define their possible scope of work. Based on your current status, objectives and available personnel, review overall resource requirements for the program to identify limitations and gaps. Consider installed solutions and positive or negative experience with all potential vendors.
Detail requirements and documentation. Plan to have a well-defined user requirement specification (URS), functional requirement specification (FRS) and request for proposal (RFP). You’ll need to define approaches for factory acceptance testing (FAT), site acceptance testing (SAT) and validation processes—installation qualification, operational qualification and performance qualification documents. You’ll also need to review existing standard operating procedures (SOPs) and make modifications to reflect the serialized state of the packaging floor. You may even have to develop new SOPs.
Training. With all of the previous planning steps spelled out and the vendor starting to implement according to plan (fingers crossed), this is the final step in preparing to become fully operational and fully compliant with this stage of DSCSA requirements.
If you’re just starting to focus on DSCSA now, these are the steps you need to take to go from panic to performance in complying with the Nov. 27, 2017 round of regulations. Although it’s not too late, remember, there is no too late. There’s no time left for procrastination.
John Jordon, P.E., is vice president of business strategies at Vantage Consulting Group.
Vito Pirrera is executive vice president of operations at Vantage Consulting Group.
