Serialization Implementation: Ensuring Compliance for Product Launch
Clarkston Consulting recently supported a clinical-stage immuno-oncology client through ensuring compliance for product launch. Read a synopsis of the project below or download the full case study.
Download the Ensuring Compliance for Product Launch Case Study Here
Our client, a pioneer in developing antibody therapeutics, is dedicated to discovering and developing targeted treatments to address the unmet needs of cancer patients. Their initial drug candidate is currently progressing toward FDA approval for treating patients with a condition with high unmet needs.
As the company prepared for their initial product launch in the U.S., they needed to comply with the US Drug Quality and Security Act (DQSA), specifically Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA). This required the implementation of a comprehensive serialization solution to manage both the serialization business processes and supporting technology. The client sought a partner with expertise in the unique needs of a manufacturer preparing for commercialization, and Clarkston Consulting was chosen as their system integration partner for this critical project.
Project objectives included:
- Implement the TraceLink Life Sciences Cloud to support the distribution of serialized drug product and exchange serialized data with client’s trading partners to ensure full U.S. market compliance with DSCSA and FDA regulations.
- Create and promulgate the serialization SOP’s and work instructions based on best practices, FDA guidance, and DSCSA regulations to enable the entire organization to incorporate serialization into the entire product release and distribution process.
- Support full integration of client’s CMO and 3PL trading partners with DSCSA data exchange.
- Implement a fully validated serialization solution including validation documents, work instructions, and SOP’s.
To achieve the project’s objectives, Clarkston delivered comprehensive services tailored to meet the client’s needs. We provided deep serialization expertise, leveraging our extensive industry and DSCSA knowledge to guide strategic decision-making based on best practices. Our team managed the project implementation, coordinating activities between the client’s Contract Manufacturing Organization (CMO), Third-Party Logistics (3PL) provider, and the serialization vendor, TraceLink.
The Clarkston team also facilitated workshops to design Standard Operating Procedures (SOPs) and Work Instructions, ensuring they met GxP standards and gained approval from key stakeholders. Our support extended to integration and deployment activities, ensuring seamless collaboration with the client’s trading partners. We developed and conducted serialization training for key stakeholders, preparing them for the system go-live. Additionally, we defined and enacted serialization support roles to sustain ongoing business operations and supported the CMO protocol for serialization validation.
The implementation of the serialization solution provided significant benefits for the client. We successfully installed a validated serialization solution that complied with Title II of the US DQSA of the DSCSA, positioning the client for regulatory compliance. This deployment was completed ahead of the commercial launch readiness activities, ensuring the client was fully prepared for market entry. The system validation, documentation, and SOPs adhered strictly to the client’s standards, guaranteeing both regulatory compliance and operational efficiency. Moreover, the project was managed within the defined scope and budget, showcasing our effective project management and resource allocation. These outcomes ensured that the client could confidently launch their product knowing they met all necessary regulatory requirements.
