Are labeling, coding, and tracking activities the most critical elements to design and implement the Serialization process?
The completion of serialization design and implementation is a major accomplishment for many pharmaceutical companies. However, once the serialization systems and equipment are in place, that’s when the real work starts. Maintaining and supporting systems, while implementing and controlling change management processes are critical success factors in meeting each milestone of the DSCSA.
Robust change management is required once the supply chain starts to receive the serialized product. New work begins as many companies start performing the 3 R’s: recalls, rework and returns. These processes will consume resources and affect tracking processes. If not controlled and executed properly, they can negatively affect packaging quality, tarnish your business image and even result in non-compliance fines from regulators or fees from trading partners.
Another change management challenge is the implementation of aggregation into internal and external systems. The industry is split on when to aggregate; some are aggregated already, and some are waiting for regulatory deadlines or a requirement from their trading partners. Those in the industry who are validated for aggregation have a jump on those that choose to have serialization-only systems, but may be incurring operating costs that are not seen by suppliers with serialization-only systems.
The advantages of installing serialization-only systems are cost avoidance and deferment. Aggregation may require additional hardware and software modules with upfront costs plus additional annual fees. Does paying for aggregation licenses make sense when it’s not required for 3 or more years?
The disadvantages to those in the industry who have serialization-only systems will be the time and money required to revalidate the entire serialization system from packaging line to ERP once aggregation is implemented. Additionally, adding aggregation into a serialization-only system may require additional packaging equipment, software installations, and reinstallation into production.
This means additional production downtime for testing aggregation (estimated at six weeks or more), time to run a full end-to-end process with the warehouse systems and time to retest the 3 R’s. During all of these steps, robust validation and change management systems are needed to ensure compliance.
Once the standalone packaging lines are connected to an IT network, it becomes part of the IT infrastructure and that infrastructure requires maintenance. A well-planned maintenance schedule will include times where the system is offline, but even the best systems will fall victim to unforeseen outages such as hardware failures, security breaches, and emergency repairs.
All those activities must be controlled and documented through change management, as well as communicated to the packaging sites, CMOs, vendors, and customers because serialization data and/or product delivery will be affected.
Release and Change management is a requirement; it’s no longer a nice to have. Completion of serialization by November 2018 is a significant accomplishment, but the necessary controls for maintaining the systems will be part of the pharmaceutical industry, always.
(Source: IPS – Integrated Project Services, LLC)