Despite the fast-approaching compliance deadline, a recent survey showed that more than 1 in 3 pharmaceutical companies and contract packagers aren’t ready. If your company is one of them, it’s time to familiarize yourself with requirements and compliance strategies to avoid unplanned downtime or regulatory issues.
Understanding Serialization Requirements
After November 27, 2017, manufacturers will no longer be allowed to ship prescription drugs without a unique serial identification code that includes a product identifier, serial number, lot number and expiration date.
Other critical requirements for manufacturers include:
Mission-Critical Compliance Strategies
If you haven’t started on the road to serialization yet, you don’t need to panic.
Instead, you need to:
Integrating Systems to Streamline Serialization
Clearly, the new requirements go beyond just slapping a new label on your bottles. From a technology perspective, effectively meeting serialization requirements calls for integration of the Laboratory Information Management System (LIMS) with other key systems such as:
More than just a practical consideration, an interoperable data exchange that facilitates traceability is one of the main goals of DSCSA. That means companies can no longer afford to manage compliance processes with one-off or manual systems—to be truly effective, they all need to be connected.
Business Benefits of Serialization
The majority of companies who are preparing for serialization are doing so purely with an eye towards compliance. While this approach is common, what it misses is an understanding of the larger benefits serialization can provide in an organization.
These benefits include the ability to:
If you’re sweating the upcoming deadline, that’s totally understandable. The thing to remember is that action is the antidote to fear, and you’ll be in a much better position to achieve compliance with the new regulations the sooner you start.
In summary, serialization should not be seen as a regulatory requirement in isolation but should be approached from a business perspective where commercial benefits can be realized through increased product security.