Are You Ready for Serialization Implementation?

By Stephanie Byrne

A 7-Point Checklist for Emerging Pharma Companies

Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to implement a serialization management solution to fulfill today’s requirements under the Drug Supply Chain Security Act (DSCSA).

So when should you start the process?

Serialization implementation typically takes 4-6 months and packaging set up drives the milestones. However, having key elements in place from the outset will prevent costly delays.

Checklist for Readiness to Start Serialization Implementation

  • You selected a serialization management solution and have fully executed the contract.

    This can take much longer than expected, especially if your legal team has a lot to review or if they are inexperienced in reviewing software-as-a-service contracts. Prepare for a lot of questions and red lines. Select your vendor early. We recommend starting your evaluation and selection process at least a year before you plan to file your NDA. This allows ample time for contract execution. Plan your serialization implementation kickoff once the contract is signed rather than anticipating a speedy review and ending up behind schedule from the start.

  • You received a labeler code, created an NDC for your product, and identified most key product attributes.

    You can’t get far in a serialization implementation without having this data defined. Key attributes include product name, description, generic name, dosage, packaging format, and quantity. This data will need to be set up in your serialization system, as well as in your packager and 3PL providers’ systems.

  • You are ready to register or have registered with GS1.

    GS1 is a global standards organization and the sharing of serialization data to meet DSCSA requirements relies on the GS1 standards. GS1 assigns you a company prefix and global location number (GLN) based on your labeler code. The company prefix and GLN are the two primary identifiers. Fortunately, GS1 registration can be done very quickly online and you generally receive your company prefix and GLN via email within 24 hours.

  • You are ready to create or have created GTINs for your product saleable unit along with homogenous case packaging levels.

    Global Trade Item Numbers (GTINs) are the standard identifiers of products at the package and homogeneous case packaging levels for serialization. It is the manufacturer’s responsibility to create these identifiers using the GS1 standard.

  • You are engaging in packaging set up.

    Contract Packaging Organizations (CPO) have their own serialization set up process. If you’re using a CPO to affix the serialization data to your products, then you will need to align your effort with theirs. A key driver for the serialization implementation schedule is packaging validation at the CPO. It is fruitless to try implementing serialization until they are ready to move forward with serial number provisioning and commissioning.

  • You expect to have your pallet pattern specification completed soon.

    In order for your 3PL to handle your serialized product, they will require you to do aggregation. This means establishing parent-child relationships for serial numbers at different packaging levels – the individual package serial numbers associated with a case serial number and the case serial numbers associated with a pallet serialized shipping container code (SSCC). You will likely need to specify the aggregation ratios when setting up your serialization master data with the 3PL.

  • You are close to engaging your 3PL for serialization set up.

    3PL selection and set up tends to happen later in the overall schedule. The good news is that 3PL serialization set up tends to be easier and quicker than packaging set up. 3PLs are also usually willing to perform serialization set up before other parts like warehouse and order-to-cash processes. You can check the box if your 3PL will be ready to start serialization within the next 4-6 weeks.

If you can check off all the items above, then you are ready to begin your serialization implementation!

Converge Consulting can help with selecting and preparing serialization management solutions, along with supporting full serialization implementations and the related supply chain consulting when you’re ready. For more information, contact info@convergeconsulting.com.

Stephanie Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from their serialization projects by bridging the gap between sound strategy and reliable execution.