为了达到药物供应链安全法（DSCSA）所寻求的单位级别可追溯性（DSCSA），其整个制药行业必须解决互操作系统的问题，以与贸易伙伴共享数据。
The overall goal of DSCSA legislation is to verify product legitimacy, make recalls more efficient, and enhance detection of illegitimate products in the supply chain. A major component of this is the requirement of serialization, the practice of assigning a unique serial number linked to product data—product origin, batch number, and expiration date—to each saleable unit of each prescription drug product.
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Just starting out? Read序列化101.。 |
“But the exchange of master data today is a manual process,” explained Allison Sheldon, senior manager, Pfizer Digital Serialization, Pfizer Inc. at a recentHDA可追溯性网络研讨会event. Serialization data is manually pulled from internal systems, and spreadsheets are maintained and emailed back and forth to trading partners.
制造商正在尝试整理的部分是他们的贸易伙伴如何在其结束时管理数据。“他们在拍摄HDA’s formsand applying changes that are required in their systems? How do we keep that data up to date? We'll see that when there's any type of mismatch, that creates failures when we're exchanging our serialized data. It's certainly not sustainable—we need to come to an automated approach,” said Sheldon.
Panelists offered resources for those starting out. (Credit: HDA)
Brad Pine，品牌制药和监管副总裁史密斯毒品公司，div。J M Smith Corporation，同意。“每个人都获取HDA电子表格并添加GTIN [全球交易识别号码] - 仍然没有很好地采用。你不断把它们送回制造商并说，'你这里没有gtin。然后从电子表格加载信息是艰苦的，因为格式，它易于错误。如果我不正确地捕获罗斯零，那么有问题。“
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阅读更多内容Gtins和案例包装在这里。 |
epcis onboarding.
答案，小组成员说，位于制造商的制造商，使用共同的框架来交换数据：EPCIS（电子产品代码信息服务）文件。
EPCIS is a global GS1 Standard for creating and sharing visibility event data, both within and across enterprises, to enable users to gain a shared view of physical (or digital) objects. Physical objects include products, logistics units, documents, and more, while digital objects can refer to items such as music downloads, e-books, and e-coupons.
Adoption is off to a rocky start. “Our biggest challenge is finding manufacturers that are willing to send us EPCIS events and get that onboarded,” said Pine. In a best-case scenario, Sheldon offered a chart showing that it takes around six weeks to onboard, covering three main activities:
- 交换主数据
- 测试
- Moving into production
EPCIS onboarding制造商的时间表（从HDA可追溯性网络研讨会上呈现的图表）。
The six weeks represents a “happy path” where everyone is talking consistently and maintaining momentum. It involves a variety of stakeholders between the trading partner and internal personnel from marketing, IT, logistics, and warehouse operations. “And this could be for just one trade partner. So keep that in mind as we look at the volume of onboarding work that we need to do over the next year and a half or so,” advised Sheldon.
Challenges
Working with wholesale distributor or dispenser partners, pharma manufacturers are running into a number of issues once they are testing or live in production. There are errors in master data files that cause failures, or a trade partner didn't have a particular GTIN—possibly due to scanning an “inner pack.”
以下标准是关键。文件中可能存在时间戳问题，并且由于Sheldon指出，因此由于时间戳问题来确定文件失败的一件事，“但是从制造商方面，我们需要回去看看，”为什么那里有时间戳问题吗？'然后你可能会发现需要碰巧到前进的地址的其他进程更改。正如我相信每个人都知道，过程更改，不要过夜发生。“
杉木回应了需要遵循标准并很快开始：“你发现有很多语法错误和剧本的方面。当您与更大的制造商交谈时，它们肯定在测试阶段，其中三个 - 其中少数人正在与我们进行测试 - 但是这三大肯定会推动这个问题。非常重要的是，我们开始测试并尽快制作生产，因为在2023年11月之前有很多需要完成，“松树说。
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读3 EPCIS Data Exchange Issues in Pharma Traceability。 |
杰夫弗莱芒，经理，医药信息技术Cardinal Health, Inc., said that in working with their manufacturing partners, another challenge is readiness. “We cite in our onboarding guide things that the company must be proficient at before starting. Communication is another area where time could be compressed. We might get a test file and we'll respond usually within a business day. But we don't know what happens once we send that response out—it may go into some kind of rework and come back. I'm not sure how closely mailboxes are monitored, but there's an awful lot of time lost just in exchanging messages back and forth,” Falardeau said. “Proficiency is all over the place. Some companies are very proficient, some are less so. That leads to situations where we might get chronology errors with the EPCIS event times—probably the largest source of errors that we get. We might be missing master data altogether, missing master data elements, or have extra master data inserted where it doesn't belong. Quite a wide variety of things.”
Baseline format
One audience member asked if there a difference in the EPCIS formats being used by various solution providers. The answer is no according to Michael Ventura, vice president, solutions & innovations atlspedia。随着时间的推移演变从1.0 EPCIS标准through 1.2 (ratified Sep. 2016). “There is a 1.3 in development... it's fluid on its timeline. There's no guarantee that it would be done and adopted by November 2023. I'll get up on my soapbox here… you need to be able to do version 1.2 to go live. That should be an expectation, because we see this all the time. One of the biggest problems we have right now is there are people running on 1.1 or even 1.0 at the beginning of the supply chain that are failing files and broken files, and they can't figure out why. Everybody needs to be working with their solution providers to be up and running on 1.2 and testing with their supply chain partner,” he said.
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看这个视频在轨道和追踪中学习的经验教训。 |
From a solution provider perspective, he added that they have the advantage of viewing partners sending and receiving data: “We're watching the type of errors that are going on that will be experienced by the entire supply chain as they get up to that space. It becomes a matter of knowing that the quality and the viability of your files are meeting the needs of your partners. Do you have some sort of monitoring and alert to know that when you fail a file? Somebody needs to be acting on it. What is the automation or the process you built to resolve that so that product isn't sitting around and you're maintaining that supply chain continuity.”
Lower volume manufacturers
EPCIS-formatted messages are usually generated through L4 enterprise systems. But there are options for generating EPCIS messages for low volume or low frequency shipments to avoid the additional costs related to new L4 modules. Falardeau explained that for those who don't have an internal IT group that can extract information and formulate EPCIS files, there are solution providers that will take data in most any form and convert it.
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Watch this interview with an用于供应链弹性的MIT PHD。 |
There is a standard template for master data that manufacturers can send to wholesale distributors to avoid sending different Excel files formatted for different wholesalers. Justine Freisleben, vice president, industry relations at HDA noted, “We have anHDA Standard Rx Product Information Formthat manufacturers can fill out. We also have a short form for GTIN updates that manufacturers can utilize.”
分销商指出，它们具有指定要加载主数据所需的元素的Excel表单或CSV文件。
3PL与制造商职责
Audience members were curious if manufacturers will need to have all their distributors or wholesalers onboarded to their serialization system to track transaction information directly, or whether their 3PL can send that information if they have it.杉木解释说：“如果你读过法律，法律刚才说制造商必须向我们发送信息[分销商]。所以这在谁将发送给我的谁是描述性的。但我很高兴从制造商那样从3PL获取来自3PL的数据。我认为每个制造商都在以不同的方式思考。他们中的一些人想控制，其他人对允许他们的3PL为他们做的工作感到满意。“
Just don’t forget that while a 3PL facilitates many activities on behalf of the manufacturer, when an FDA auditor comes in and asks for information, the manufacturer is ultimately responsible.
Verification router service
When Pine’s company surveyed manufacturers about whether they would be using a verification router service (VRS) system for theDSCSA的可销售返回验证要求，许多人提到他们想要使用EPCIS文件。“很多人都在使用3pls。我认为他们认为他们可以通过使用EPCIS来绕过VRS，并且在很多活动中，这可能会是真的。但VRS是我们在没有EPCIS事件的返回时可以想到的唯一可行的事情，当我们没有EPCIS事件时，“松树说。
Ventura said this brings up an important point about VRS and industry preparedness: “Something as philosophically simplistic as ‘I put a number on a product, I put it into the supply chain, it's on a barcode somebody can scan, and with a network, hit my database and verify its authenticity’ should be clean and simplistic. We received that FDA enforcement discretion [for returns verification] in 2020 for an obvious reason. There was a concern that itwasn'tthat simplistic and that it could cause supply chain disruptions. [Master data exchange] is exponentially greater in its magnitude and its detail to get right, so obviously the challenges are real here.”
Future considerations
- At present, there are downstream trading partners saying that they haven't had distributors approach them about data exchange. Panelists said they would be turning their focus to dispenser interactions in 2022.
- How will data flow work for drop shipments in the future? This is a topic the panelists have just begun working on with an HDA work group or in their organizations. Pine noted that in the DSCSA, that action is a manufacturer-to-dispenser issue. They’re just beginning to see if there are ways that wholesalers can be a conduit in a meaningful way. The work group is the HDA Traceability Implementation Work Group, which is a member-exclusive group. For more information, contact jfreisleben@hda.org.
Closing advice
The main point panelists hammered home is (1) to ensure you have processes (resources, tools, and SOPs) for exception management and (2) to get help with data exchange as soon as possible if you need it. “Full and timely adoption for exchange with manufacturers and distributors is key. Risk and impacts are very high and extreme if we can't ship product for which we don't have the data. So when files come in, if they fail, we need to react quickly,” said Falardeau. “Cardinal Health looks to invest in automation to help with that, to work with manufacturers, and to reduce that turnaround time. But as I alluded to earlier, there's a wide range of proficiency levels right now and manufacturers, if they're not already, really need to start pulling themselves in here to get up to speed more quickly or seek help from solution providers. We also highly recommend conformance testing companies that will help you learn EPCIS or help you be able to test rapidly. For now, we're just really concerned about the runway left and the number of manufacturers that still need to jump in the pool here and start testing with us before 2023.”
问问自己的问题
- Timeliness of exception management: Do you have a process in place that will alert you when there's a failed file? Do you have resources, tools, and SOPs in place to manage this?“The worst thing that can happen here is product piling up on the receiving dock without a good file to receive it against,” said Ventura. “Obviously that exception management is going to be critical to not only get everybody onboarded and understand what they're supposed to do, but also what to do when things don't go right.”
- 人:你准备好th的学习曲线e warehouse to ramp them up?根据操作的大小和体积，您可能需要额外的资源或时间。“我们对技术和一些流程进行了很多谈论了很多，但也有大人物在实现这方面的组成部分，”谢尔顿指出。
- Data: Once you have data, are you able to send it to partners?3PLS正在船上，现在意识到他们可能会为较小的制造商做很多工作。“我第二天在和他们说话，”是的，“是的，我们已经得到了所有的信息，它会很棒。”我问他们是如何让我的。这有点像，'哦，我也应该把它送到你身边吗？“那就是我认为我认为真正能够帮助解决这些较小的制造商的地方，”这是较小的制造商的地方。“
