The FDA held its second DSCSA-related public meeting last week, bringing together a wide range of pharmaceutical supply chain stakeholders in order to take the pulse of the industry’s serialization and product-level tracing implementation efforts. In addition to absorbing a lot of interesting best practices, LSPediA was honored to have been invited to present our own findings and insights on product identification.
One key task at the meeting was for the FDA to collect input on how it can help improve compliance for manufacturers, wholesalers, and dispensers. This effort is being driven by the fact that there is still a major lack of awareness around DSCSA and serialization. Based on their own research, one major serialization packaging provider suggests that 80 percent of pharma manufacturers will not meet the serialization requirement before the 2017 deadlines.
Other problems include gaps between business and regulatory requirements, and differences in aggregation. “Aggregation is not a 2017 regulatory requirement,” said Dr. Ilisa Berstein, Deputy Director of the FDA’s Center for Drug Evaluation and Research’s Office of Compliance, during the meeting. However, every manufacturer who sells to the big three wholesale distributors have received communication letters requiring aggregation.
LSPediA: Implementing Product Identification
With several years under our belts working with clients to implement serialization, and with the recent launch of our new RxChain traceability solution, we wanted to share our thoughts and experiences on product identification with the assembled group. Specifically, we wanted to highlight our observations of serialized labels and serialized data exchange as they exist today, as well as our model of enabling serialized data collection by scan-in, scan-out, and verify.
Efforts on Implementation – Labels
We blogged a few weeks about how serialized products are trickling into distributor warehouses. On close inspection, we found a lot of room for improvement – and concluded that it’s critically important for manufacturers to adopt label standards. The reason is that (as I’ve said before), good labels are all the same, but bad labels are bad in unique ways.
For instance, we scanned various 2D matrix barcodes and found a good deal of inconsistency: codes with four data elements, some with six, and others with one or two. This is a major concern for distributors and dispensers, whose scanners can’t parse, read, or collect the data if the 2D code isn’t standardized.
Another issue we found was 2D barcode data that was inconsistent with data in the readable text. There’s no agreed-upon understanding of how big a problem this is, or any organized effort to correct the issue.
These are just two of many findings regarding labels. The others are laid out in the image below.
Efforts on Implementation – Data Exchange
We next discussed our efforts to support supply chain data integrity, an issue we and others in the industry are deeply concerned about. Let me explain just a couple of issues.
Exceptions, such as QA samples and damages, are always reconciled as inventory. But from the serialized data perspective, not every company reconciles their data when exceptions happen. For example, if one case is damaged and removed from a pallet of 40 cases, the inventory record shows the pallet now has 39 cases, but the serialized data still shows 40 cases without data reconciliation.
Another issue is serialization data being decoupled from ERP. In order for a company to close the book, their ERP data has to be correct. Decoupling the serialized data system from ERP removes concerns about bad data impacting ERP data quality. On the other hand, it concedes that there are errors in the serialization system.
Our other findings regarding data exchange are laid out in the image below.
Scan-In, Scan-Out, and Verify
In closing, we recommended that pharma manufacturers, distributors, and dispensers take a multi-channel approach to serial data collection. RxChain, our traceability solution, simplifies that process through these three steps:
- Scan-in – Inspect the label and data quality before receiving the data feed.
- Scan-out – Capture data on packages and cases as they’re shipped out. Collecting this “data truth,” or data read directly from the physical package, will eliminate problems with data feed and interpretation.
- Verification request – Collect inference data from the data origin – i.e., manufacturer’s data.
LSPediA: Your Serialization Partner
Supply chain integrity is the key to better drug manufacturing and distribution processes, but it’s also the backbone of improved business practices and organizational efficiency. To be sure your organization is compliant with complex DSCSA serialization and traceability requirements, you need a partner with deep experience and tested solutions. LSPediA can ensure your implementation goes right the first time – and gives you a competitive edge. Contact us to see how we can help.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.
For more information about LSPediA, call +1 (248) 973-2008, email [email protected], or visit our website at www.lspedia.com.
For additional information, contact: Julianne Jahn [email protected]