Will the US DSCSA misalignment exception disrupt your supply chain?
How can it be resolved quickly and cost-effectively?
Introduction:
A pressing issue for supply chain entities involves recognizing, understanding, and addressing misalignment exceptions. These exceptions occur when there's a discrepancy between the physical and virtual aspects of the supply chain. They specifically refer to situations in the supply chain where the transaction information (TI) mandated by US DSCSA doesn't perfectly match the physical products being exchanged.
Approximately 8 to 10 billion package-level transactions occur annually, making errors and discrepancies unavoidable. The process for handling exceptions must remain separate from that of investigating suspect products. An exception might trigger a suspect product investigation, but not necessarily so.
According to the Exceptions Handling Guidelines for the DSCSA published by the HDA, appropriate timeframes will be established through business discussions between trading partners. If a trading partner detects a potential clerical error or other discrepancy in the received product tracing information, they are expected to resolve it within an agreed-upon number of business days. The draft guidance advises trading partners to collaborate on resolving these issues and states that the product should not be sold to the next trading partner until the error or discrepancy has been addressed.
When a misalignment exception is identified, the concerned package(s) should not undergo further transactions until the exception is comprehended and resolved. Trading partners must possess systems and processes to detect, understand, and address misalignment exceptions.
Resolution often depends on cross-functional interactions within and between companies, including third-party agents, external stakeholders, and manufacturers.
CosmoTrace offers a compelling value proposition for effectively managing misalignment exceptions:
Exception Scenarios: The following business scenarios may lead to misalignment or exceptions:
Scenario 1.1: The wholesale distributor was sent the data, but the EPCIS file is not correct in content or format as prescribed in the GS1 EPCIS implementation guideline.
Scenario 1.2: The wholesale distributor receives data, but the Global Company Prefix (GCP) and/or GLN/sGLN are not found in the receiver’s master data.
Scenario 1.3: The wholesale distributor receives the data, but the GTIN is not found in the receiver’s master data.
Scenario 1.4: A wholesale distributor receives data, but there is a misalignment between the data received and the lot number and/or expiry encoded and successfully scanned in the two-dimensional data matrix bar code (2D bar code). This scenario covers incorrect data.
Scenario 2.1: A manufacturer sends an EPCIS file for a shipment, but there is a communication issue, and the file was not received by the wholesale distributor.
Scenario 2.2: A wholesale distributor receives a product, but the serial number is not found within any EPCIS file delivered and there is no purchase order or delivery number to reference.
Scenario 2.3: A wholesale distributor receives a shipment in which the serial numbers are not found due to the wrong data being sent. There is a valid purchase order number to reference.
Scenario 2.4: A wholesale distributor receives a product overage with a valid purchase order receipt in which the shipment references the purchase order.
Scenario 2.5: A delivery was made to the right company, but to the wrong distribution center within that company. Note: This is not a DSCSA compliance issue. Because the delivery was made to the correct trading partner purchaser but the wrong facility within that company, the decision on how to handle this scenario should consider other regulatory, statutory, or business requirements.
Scenario 2.6: A delivery was made to the wrong wholesale distributor.
Scenario 2.7: A serial number is not found while a wholesale distributor is trying to pick, pack, and ship.
Scenario 3.1: The manufacturer sends data that includes products not received in a wholesale distributor shipment, resulting in a shortage.
Scenario 3.2: A manufacturer sends data received by the distributor, but later the manufacturer cancels the shipment (in full or partially) or the carrier fails to deliver the product.
Scenario 3.3: A manufacturer sends data that are received by the wholesale distributor, but the shipment is refused because product is deemed unsaleable.
Scenario 3.4: A manufacturer sends data that are received by the wholesale distributor, but the shipment is refused even though it is saleable.
Scenario 3.5: A manufacturer sends data for a shipment that is to be received by a wholesale distributor, but the shipment or partial shipment is stolen.
Scenario 4.1: A wholesale distributor scans a product at receiving or when preparing it for shipment that shows a mismatch between product label and the transaction data that the manufacturer determines is a labeling issue.
This scenario is related to section 1, scenario 4.
Scenario 4.2: A wholesale distributor discovers when receiving a product or preparing it for shipment that the product has no Human Readable Interpretation (HRI) of the 2D bar code on the label (i.e., the GTIN, serial number, lot and/or expiry are not included in the HRI).
Scenario 4.3: A wholesale distributor discovers during their operations that the Serialized Shipping Container Code (SSCC) is damaged, unusable, or missing. Note: This is not a DSCSA compliance issue; the DSCSA does not address the use or placement of the SSCC; the DSCSA requires that only covered drug packages and homogenous cases must bear product identifiers.
Scenario 4.4: A wholesale distributor receives a product or is preparing to ship it and is unable to read the 2D bar code because it will not scan, is encoded incorrectly, or has incomplete elements.
Scenario 4.5: A wholesale distributor discovers there is an aggregation error in the EPCIS data it received from the manufacturer.
Scenario 5.1: A wholesale distributor discovers a serial number or lot number is unavailable for distribution due to being recalled, suspect, or illegitimate.
Reference:
- EXCEPTIONS HANDLING GUIDELINES FOR THE DSCSA Version 2.0, October 2023
- https://dscsagovernance.org/wp-content/uploads/2023/03/Exception-Handling-Workshop-Report-.pdf
- For additional information, visit DSCSAgovernance.org
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the pharmaceutical serialization requirements.
Our team of experts strategizes and plans end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences, and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
