PRODUCT SERIALIZATION FOR A LARGE PHARMACEUTICAL COMPANY
of serial numbers
dedicated team members
of auto-mapped serial numbers
By 2020, approximately 90% of prescribed medications worldwide are expected to be serialized. Pharmaсeutical companies are in various stages of implementing serialization across their supply chain to meet emerging regulations. As those are still are still evolving, a standard approach to serialization with well-established ways of working is still in progress.
Our client is a global pharma company pharmaceutical company that develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, diabetology/endocrinology, and neurology.
Apart from packaging, serialization also affects business processes in supply chains, manufacturing, quality, inventory management and regulatory reporting. The implementation of Serialization is further complicated when a company, like our client, engages or outsources manufacturing and packaging to CMOs.
Each CMO has various approaches and strategies to comply with serialization regulations. This makes the whole serialization initiative significantly more complex.
The client has developed a comprehensive serialization solution that involves both business process and technical aspects of the serialization solution.
It has been agreed which parties generate serial numbers, but it still required automated, semi-automated and manual efforts to map serial numbers and serialization batch data between the company and CMOs for reporting purposes.
Our engineers have been working on appropriate data exchange format, including serial number format and the corresponding master data requirements. While it allowed to automatically map a significant number of data sets, a good chunk of work is done manually. This is handled by our separate BPO team.
We are currently working on a Pilot project to test various approaches and solutions to handling the mapping of serial numbers and accommodate yet evolving regulations.
Once the pilot exercise is complete and several standard execution approaches are developed, this initiative will be replicated across all CMOs based on various solution designs.
Complying with mandatory serialization regulations across geographies is a herculean undertaking. But since it is mandatory, not optional, delaying serialization poses a real risk of product disruptions in key revenue-generating markets and potential for financial setbacks.