Serialization within the pharmaceutical industry is the allocation of a unique serial number to the “unit of sale”, and potentially aggregation to the further packaging (box, pallet, etc.). Reports needs to be generated of the data, including meta-data and structure, and submitted to the customer and local authorities. This system of allocating a unique serial number has been developed for various reasons:
- Counterfeiting of medication
- Tracking of different medications
- Government’s obligation to display the origin of medicine
- Efficiency of the entire Supply Chain
Purpose of the function
- Managing the customer serialization implementation from scope up to production hand-over.
- Involves all relevant functions within each department of the organization to get each aspect of the serialization project covered.
- Translate the customers’ requirements into the project scope.
- Guards the project scope.
- Translates the project scope to the organization.
- Maintains a constructive relationship with the customer.
- Manages all serialization scope changes in the project.
- Ensures a transparency on the project status towards the organization.
- Ensures delivery of the serialization project within timelines, resource consumption, budget and scope.