Serialization for a Pharmaceutical Manufacturer
Case Study
One of the largest multinational pharmaceutical corporations that provides medical solutions to address the evolving needs of patients worldwide must always meet and comply with serialization requirements. Laws are continually being revamped and in the case of the latest Drug Supply Chain Security Act (DSCSA) 10-year implementation – regulations now demand the ability to track and trace the transaction history of every medication that is sent to pharmacies. Managing DSCSA requirements is as critical for ensuring patient safety as is the need to conduct business in an interoperable environment.
The Need
Prescription medicines must be marked with unique identification numbers which necessitates an incredible amount of highly- technical expertise on the part of pharmaceutical manufacturers as it requires intervention in multiple sensitive processes and configuration of software – along with integration into cloud and collaborative hub services to make the entire process work with an unmatched level of precision.
The Maverick Solution
The Maverick team of consultants, including a Project Manager who became the Serialization functional lead, implemented a new application for Serialization and deployed it in full compliance with the Drug Supply Chain Security Act (DSCSA) with no compromises. An innovative serial number management solution (SAP Advanced Track and Trace) was built to label and track products with serial numbers that minimized the costs of maintaining compliance. The solution required a full breadth of knowledge in baselines from the perspectives of business and warehouse operations and corresponding systems. The work continues, as the pharmaceutical manufacturer is now preparing to provide individual unit traceability through the entire secure supply chain.
Customer Benefits
Beyond the safety of patients, now the pharmaceutical manufacturer has clear and comprehensive supply chain visibility and can easily keep an eye on where the materials are located while monitoring and supervising their logistical operations more effectively and efficiently. With quality serialization in place, the scannable codes can aid to discern between genuine products and counterfeits. An additional benefit is the ability for the pharma manufacturer to better understand the demand for their products so they can proactively ramp up production to fulfill future orders.
