The US Food and Drug Administration (FDA) June announcement of its intent to not take action against pharmaceutical companies and CMOs not meeting the requirements of the Drug Supply Chain Security Act (DSCSA) should not be interpreted as an extension of the deadline. However, it can be interpreted as the FDA’s acknowledgement that the industry may have underestimated the amount of time and resources required to be serialization ready.
In spite of the FDA’s announcement to postpone enforcement until November 2018, all other requirements of the DSCSA remain the same: packages must be marked with a product identifier, serial number, lot number, and expiration. From there, the remaining deadlines for other stakeholders in the life sciences supply chain are staggered throughout the remaining six years of the regulation’s 10-year plan. By 2023, the goal is to have achieved item-level traceability from end to end that will allow detection and/or tracking of suspicious or dangerous products in the pharma supply chain.
However, just serializing your product will not be enough for the upcoming deadline. The FDA also mandates that pharma companies must be able to send each product’s transaction information, transaction history, and transaction statement (collectively known as T3 documentation) electronically. While the DSCSA has required since June 2015 that T3 documentation be sent with each batch, the move to electronic format is an important step toward more enhanced product tracking in 2023. Nevertheless, millions of products moving through the supply chain every day means massive amounts of data moving with it. Like all complex projects, as companies embarked on the process to become compliant with the DSCSA, they encountered some unexpected challenges. One of these being the job of managing and effectively sharing this immense amount of data.
With a supply chain that can be host to a multitude of partners and customers, developing and implementing a system that can handle that amount of data is one of the biggest serialization challenges contract service partners face today. Without this, it is impossible to support existing and future customers once the November mandate goes into effect.
To understand why data management is such a major challenge, you must understand the complexities associated with integrating this data and what organizational barriers a data management system must be able to overcome in a serialized world.
A Data Problem In An Electronic World
To paint a picture of exactly how much data a contract service partner must be prepared to manage, consider information from TraceLink, a provider of track and trace network solutions for the life sciences industry. The company has worked with more than 530 companies across the supply chain on their DSCSA compliance strategies. Annually, its largest customer will issue about 18 billion serial numbers. Each of those serial numbers will be used for an average of five transactions before the manufacturer even ships the product. That is at least 90 billion pieces of data that must be validated and managed. Any contract service partner working with that company must be able to store each of those transactions and the associated serial numbers for at least six years as required by law. However, it is recommended the information is stored for a period of at least 12 years, in order to accommodate external business factors beyond regulatory reasons, such as product recalls, product-related litigation, etc. This is to ensure complete coverage for the regulations and for any potential verification requests.
To make matters even more complicated, all of the regulated data moving through the pharma supply chain must also be exchanged with other stakeholders in the supply chain; however, the DSCSA does not specify what format should be used to do so. And the FDA has no plans to mandate one. They are leaving it up to the industry to decide on what format should be used and will hold the industry accountable for successfully implementing whichever one is chosen.
Currently, there are multiple formats being used to track T3 information. The GS1 global standard Electronic Product Code Information Services (EPCIS) is favored by many in the industry for the exchange of serialized compliance data. There are currently three versions of EPCIS in use in the industry (versions 1.1, 1.2, and 1.3). However, instead of EPCIS, many wholesale distributors still prefer to use the Healthcare Distribution Alliance (HDA) Advance Ship Notice (ASN) format, which includes compliance data and logistical information. These multiple formats add to the complexity of data management because a company defines its IT infrastructure, such as its internal line system and internal enterprise resource planning (ERP) system, on whatever format it chooses. Once a contract service partner upgrades its packaging lines to support serialization and validates its system, it will then need to reach out to each of its customers to complete end-to-end testing and ensure the successful transmission of data, regardless of whether or not the individual system is using the format designated by the industry.
In addition to multiple formats, each company can dictate its own requirements based on what supply chain information it wants to track. Data from the Global Drug Supply, Safety & Traceability Report demonstrated that half of pharmaceutical manufacturers had to modify their systems in order to meet their customers’ data requirements. Because of these unique and complex data requirements, there can be a need for additional transactions, which can be host to a variety of issues. For example, some companies may have limitations on the amount of serial numbers they can accept in a given transaction. In a situation where a company could accept only 1,000 serial numbers in a transaction, the commissioning file that includes batch information must be broken into transactions of 1,000 serial numbers or less. Each transaction cannot split the case, so the file needs to be split during transmission and then recombined. The time it will likely take a contract service partner to ensure support of unique exchange requirements and protocols such as this only adds to the already lengthy timeline of implementing a serialization project for each customer.
Racing The Ticking DSCSA Clock
Based on the challenges above, it is clear that serialization compliance requires both internal and external support. Implementing a project that stretches across organizational boundaries can present a number of resource conflicts and dependencies that are outside of a contract service partner’s control. The challenge most contract services partners encounter is they discover too late that they have not allotted enough time to integrate with their customers. They also often do not account for the fact that their customers are likely working with other partners as well.
Clearly, the race against time is no longer just a race to serialize your product; it is also a race to develop an effective system that can integrate regulated data and extend a connected and validated bridge of communication to trading partners across the pharmaceutical supply chain. Manufacturers must seek a timely solution to the upcoming mandate to ensure their product can enter the market fully serialized and supported by an experienced serialization group.
About Ropack And TraceLink
Nicolas Girard is the chief operating officer at Ropack Pharma Solutions, and Graham Clark is the co-founder of TraceLink as well as its CMO/CPO partnership manager. When learning the industry is unprepared to meet the DSCSA requirements of November 2017, Ropack and TraceLink, along with Optel Vision, worked together to develop an international serialization hub. The goal is to provide the industry with a solution that allows a pharmaceutical product to enter the market fully serialized with support from an experienced partner. Manufacturers not ready for the November deadline can have their in-house packaging team or contract partner send pharmaceutical products to the hub, where stand-alone serialization stations serialize, aggregate, and eventually ship products to their next location in compliance with DSCSA. The data connectivity through TraceLink provides product integration with many of the world’s manufacturers, including those in countries where serialization has already been adopted. The hub can be used as a temporary solution until a manufacturer has implemented its own serialization program or as a permanent solution that can reduce its capital expenditures.
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