Strengthening the Chain: Addressing Pedigree Challenges Across Outsourced Operations - Manufacturers should begin preparations now to be ready for the coming requirements. - BioPharm International

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Strengthening the Chain: Addressing Pedigree Challenges Across Outsourced Operations
Manufacturers should begin preparations now to be ready for the coming requirements.


BioPharm International
Volume 21, Issue 10

Warehousing and Distribution

Warehousing and distribution centers (DCs) must be properly equipped to store, manage, and ship serialized product as it enters the supply chain. Handling serialized product will require investment in new barcode or RFID scanners and changes to the inbound material and order fulfillment processes. In addition to the equipment and process changes, the necessary IT infrastructure must be in place to couple the serialization data with order details, invoice information, and previous shipment history. This information must then be electronically transmitted to trading partners in the form of a pedigree or RxASN.

Furthermore, both California's and the proposed federal law require a legally-binding certification that the contents of the shipment match the pedigree. As a result, manufacturers must have an authorized representative on site at the distribution center—an individual legally authorized to act on behalf of that source, and whose attestation and accompanying (digital) signature may legally bind the person or entity. At many outsourced distribution centers, however, the manufacturer may not have any employees overseeing the pick, pack, and ship process. Because the manufacturer is ultimately responsible for the accuracy of the pedigree, it is critical that significant attention be given to the controls and procedures in place at the 3PL to reduce the risk of non-compliance.

IT Interoperability

At heart, pedigree requirements are about information capture, visibility, and tracking. As a result, a core component of managing serialization and pedigree data lies in IT infrastructure, and the degree of interoperatility and timeliness it provides. As new IT systems and software are implemented at packaging sites, distribution centers, and at the corporate level to support serialization and pedigree compliance, it will be critical for each of these systems, across different enterprises, to be fully interoperable. Otherwise, the data transfer between systems may be limited, preventing a manufacturer from performing all the necessary activities to generate a pedigree. This places extra emphasis on coordination during the implementation and testing phases at the various locations so that all systems are ready to go live in approximately the same timeframe. A lack of interoperability or a delay at one location will increase the risk of non-compliance.

Because the pedigree must be received before a customer can introduce product into inventory, many companies with outsourced distribution are faced with timing challenges of file transfers. Daily batching of transactions may be inadequate to support expedited or overnight deliveries. Additionally, California law currently mandates that pedigrees must include the invoice number. As a result, in situations where the product is shipped overnight and invoicing is done nightly, it can be problematic to create an invoice and provide the invoice number to the 3PL in time to include it in the pedigree. California law also requires that the pedigree arrive before the physical product can be released for further distribution. If a pedigree is created incorrectly or delayed, trading partners will be unable to accept the product into inventory. A partner's refusal to accept product will not only create more work for both the manufacturer and partner, but will lead to delays in the sale and distribution of product.

As many biotechnology and pharmaceutical manufacturers can attest, outsourced packaging and warehouse operations already lead to a distribution of IT systems and data, not just across sites of the same company, but across multiple partner organizations. The addition of serialization and pedigree data across this network brings a few unique challenges of its own. Although serialization data are captured at the CMO, these data must ultimately be transferred to the manufacturer (or, in fully outsourced environments, to the 3PL) and future trading partners. As a result, the interoperability and the timing of systems integration across multiple companies are critical to the creation of valid pedigrees.

Even after the transactions have been executed and transferred faithfully, an additional challenge lies in the storage and ongoing management of serialization and pedigree data. Because pedigree data will become a compliance issue, access to these data both now and in the future (potentially 5–7 years) is vital. Therefore, control and access to the systems and the data are critically important. Since this level of dependence can tie a manufacturer to a supplier even further, and could potentially cause delays in responding to regulators, many nervous manufacturers struggle with the decision to rely on outsourced partners to control and manage these data.


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