By: Alcami May 31, 2017 9:00:00 AM
Regulatory Compliance Serialization Supply Chain
The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many challenges. There can be an impact on productivity if your Serialization and Track/Trace systems are not prepared. Poor implementation plans can cause operational bottlenecks for several years as additional requirements are steadily implemented from now to 2024. As each system goes online, it will be necessary to “work out the bugs” and provide additional training for production and warehouse personnel.
Implementation costs may be an obstacle for smaller companies. Although the up-front costs will be fairly well defined, i.e., the purchase of software and hardware to create a serialization system, less defined are the costs to upgrade IT infrastructure. The setup of the serialization system and associated databases, ensuring compatibility between the serialization system software and other software management systems in a facility and long-term maintenance of databases may stress already stretched IT and production departments.
Serialization efforts must be scalable to support increasing DSCSA tracking requirements from now to 2024. A tremendous amount of tracking data will be generated at many levels. The technology components for unit level traceability are listed below.
Unit level serialization – November 2017 – serial numbers must meet FDA’s SNI guidance. The 2D barcode is anticipated but not required; GTIN barcodes could also be used. No standard is mandated.
Local data – Storage of the assigned serial numbers and the business processes that they interact with. This includes serial number allocation, communication with serialization equipment to assign numbers, storage of production data, communication with aggregation devices and communication with enterprise level systems, i.e. shipping and receiving and inventory management systems.
Aggregation – Tracking at the pallet or case level (typically shippers, warehouses, distributors and possibly dispensers), if the case is not opened until it reaches the retail site. Aggregation pass through points need traceability back to the manufacturer in case of an investigation or damage, i.e. a pallet is damaged or dropped and broken open. In the case of loss/damage, the aggregate continuity may be considered lost, and every serial number in the aggregate will likely need to be verified. Software services will need to identify individual numbers in an aggregate, if necessary.
Shared data – Supply chain partners will need to share product location and transaction information throughout the distribution process. This may be difficult if partners use different software systems.
There is no current agreement on how the accumulated data and databases generated from the Track/Trace activities will be managed. Three possible models are:
Distributed model – each organization stores its own data and is responsible for transmitting it when required. This may create difficulties if partners use different software systems and a standard data format is not mandated.
Semi-centralized model – organizations transmit data to one of several databases managed by third parties. So far, no third party has proposed to provide this service.
Centralized model – organizations transmit traceability data to a single repository run by a public or private entity that is managed by the government or an industry consortium. This model would require that vendors of serialization software standardize data and database format so that information can be easily shared.
At this point in the implementation of DSCSA requirements, the greatest challenge appears to be how the data will be managed. Standardization of the data format has not been mandated by FDA but it seems that a standard format will be essential if data is to be easily shared among partners in a supply chain.
To learn more about serialization and how it affects your company, be sure to register for our on-demand webinar, “Get on Track with Serialization: Lessons Learned,” featuring Lee Murtagh, project leader for Alcami's serialization implementation.
*Please note that since the original publication of this blog entry, the serialization deadline has been extended to November 27, 2018.
FORMULATIONS SPOTLIGHT: Clinical Supply Manufacturing
Alcami’s Extended Workbench Supports Commercial Supply of Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
Durham, NC (USA) – June 13, 2018 – Alcami Corporation, a leading provider of fully-integrated...
FORMULATION DEVELOPMENT SPOTLIGHT: Devon Dodd