In an increasingly complex pharmaceutical value chain, integration points between manufacturers and their pharmaceutical 3PLs can be wrought with challenges. With the quality and efficacy of your product and the speed and efficiency of your supply chain on the line, solving these challenges mitigates risks to your business’s financial health and reputation.

As a part of the Drug Supply Chain Security Act (DSCSA), manufacturers must pass serialization data to their downstream partners. Previously, we’ve covered challenges and solutions in integration with contract partners. Leveraging experience integrating one of the largest U.S.-based pharmaceutical 3PLs into a multinational pharmaceutical manufacturer’s global Serial Number Management solution, we’re highlighting some of the unique challenges and their solutions here.

CHALLENGE: Lack of procedures in place to manage the exceptions (how, who, what), including roles and responsibilities, SLAs, etc.

• Define roles and responsibilities from the start of the integration
• Document expectations in SLAs for all partners (Serial Number Management solution vendors, suppliers, etc.)
• Clear detail process exceptions and determine a process for handling exceptions

CHALLENGE: Misalignment on what master data the pharmaceutical 3PL will maintain between up- and downstream supply chain partners.

• Amend the master data the contract manufacturer or manufacturing plant provides before transferring the data to pharmaceutical 3PL to limit the maintenance efforts on their end and to ensure all that the master data the 3PL is receiving is in the same format. This will also limit their master data entry.
• As an added benefit, this will keep your supplier network confidential.

CHALLENGE: ERP process and Serial Number Management processes are disjointed

• Ideally, all design sessions for ERP and Serial Number Management solutions happen together. Avoid designing the solutions in silos to mitigate the risk of confusion or misunderstanding.
• Ensure your serialization project manager or partner has oversight of both the Serial Number Management and ERP design and efforts.
• Institute collaboration between the manufacturer ERP or Serial Number Management and 3PL.

CHALLENGE: Confusion and misalignment on file formats and interpretations

• In design sessions, ensure syntax is discussed and agreed upon before any development begins.
• Come to a common understanding of how the files are interpreted.

CHALLENGE: System cannot handle volumes/ file sizes

• Stress test systems to ensure they can handle any file size.
• Test with 150% more data than the largest batch size to ensure any potential batches will be able to be transferred in the future.

CHALLENGE: Ensuring quality on-time delivery of deliverables by vendors

• Strict vendor management is critical. Ensure all parties are available and aligned on a timeline
• As mentioned before, ensure SLAs are updated to reflect activities and that vendors are measuring up to what is outlined in their SLAs
• Have scope clearly defined and closely manage all parties to ensure everyone is working toward the same goal

As a recognized industry leader in supply chain services and serialization, Clarkston’s team of consultants combine top-notch functional expertise with deep industry experience to drive solutions that fit your industry, your business, and your objectives. Learn more about our serialization expertise here and don’t hesitate to contact me to understand how we can help drive your business forward.

Co authors and contibutions by Megan Weldon and David Betts