Tapemark

PHARMACEUTICAL SERIALIZATION

PHARMACEUTICAL SERIALIZATION

ABOUT SERIALIZATION

Here at Tapemark™, our serialization process is robust and rigorously tested. With several serialization lines, we have experience performing aggregation on multiple levels with multiple products. We follow HDA guidelines and GS1 standards for proper EPCIS formatting and label structures. We have met all DSCSA requirements and are confident in our ability to produce fully traceable products.

OUR PHARMACEUTICAL SERIALIZATION PROCESS

At Tapemark™, we are able to guide products through the necessary steps to develop, test, validate, and approve a process for serializing a pharmaceutical product in a reliable manner. We have full vision inspection on the lot code information and bar code data. Each product is scanned and verified upon aggregation to ensure accuracy. Below is a typical step-by-step serialization process at Tapemark.

1. Configure connection from line-level machinery through L4 provider database to customer and final product shipping location
2. Perform batches in the test environment to ensure serial numbers and batch reports transfer correctly
3. Validate all serialization and aggregation of test batches and the communication through all the systems
4. Begin commercial production with saleable product