HDA Traceability Seminar Recap
October was certainly a busy month for the Adents Team. We participated in several events including, Pack Expo in Chicago, the HDA Traceability Seminar in Washington, DC, and the Pharma CMO Summit in Princeton, NJ to name a few.
One of the goals of the Traceability Seminar was to update attendees on where the pharmaceutical supply chain is in relation to achieving Drug Supply Chain Security Act (DSCSA) compliance. We learned many valuable pieces of information and wanted to recap them for you in case you missed it.
Probably one of the most important presentations of the conference came from Dr. Ilisa Bernstein, Deputy Director, Office of Compliance, Food and Drug Administration who made some significant statements. Her first statement was that there will be, “No Extensions” to the DSCSA timeline. Dr. Bernstein also stated that FDA will be further focusing on the licensing process of wholesale distributors as well as beginning the era of enforcement for DSCSA.
We also learned:
- 93% of manufacturers plan to ship first serialized products by November 27, 2018
- 88% of manufacturers plan to aggregate unit to case between now and 2023, 45% by November 27, 2018
- 17% of manufacturers plan to send EPCIS data for all products by November 27, 2018, 33% by November 27, 2019, the rest later or unsure
- 56% of manufacturers have concerns with the ability to verify product identifier for 2019 to meet the saleable returns requirements and the reliability of VRS. Although during the seminar the participants of the HDA task force for saleable returns acknowledged the maturity of the solution proposed on the market.
- 36% of manufacturers plan to send EPCIS files, 42% plan to use VRS, 22% indicated they didn’t know yet. To answer this point, the panel on VRS with members of the main wholesale distributers stated that manufacturers should get a VRS unless they are sure 100% their downstream partners are receiving their EPCIS files and doing self-verification
- GS1 has proven via a pilot that GDSN is ready to support the sharing of appropriate master data attributes to facilitate EPCIS exchange
Adents is among key DSCSA solution providers for serialization, compliance and traceability. As DSCSA and FMD deadlines are rapidly approaching, Adents is partnering with manufacturers and pharmaceutical companies to provide them with the most powerful and reliable serialization and traceability solution.
This is why Adents regularly participates and supports the HDA, fellow supply chain colleagues, and industry traceability experts to provide details on the progress toward this milestone.
If have questions about the serialization process and how to start, please contact our team. We are here for you and your success. Our experts have many years of experience in this industry and we want to share our best practices and advancements in serialization with you.
To read more about how a leading Contract Manufacturer (CMO), chose to address drug serialization requirements from the USA, Brazil, South Korea and China by implementing serialization on 7 packaging lines at 4 different sites: