A large mid-western pharmaceutical company planned to remodel their existing packaging lines in order to comply with the new Track and Trace” requirements, also known as serialization. Serialization identifies each saleable unit with a unique serial number and captures the serial numbers during the pick/pack/ship process in distribution to trading partners. This was the first serialization project that the client had attempted within the facility.
Performance Validation was engaged by the client because of PV’s experience in managing qualification projects within the facility and the demonstrated ability to interface effectively with diverse project teams. Performance Validation provided a life-cycle approach to the project and was involved in planning, development of the qualification documents, review, evaluation of testing, test problem resolution, and development of summary reports. Specifically Performance Validation provided:
The packaging line modifications were successfully completed on time and on budget. This included the development of the qualification documents for new equipment and/or the update of existing documents to reflect the completed modifications. The results included:
On completion and release of the modified packaging line, the facility demonstrated the ability to perform serialized packaging, meeting the regulatory requirement for track and trace. Based on the success of this project, the client will move forward with similar modifications to other packaging lines such that the entire packaging facility will meet the regulatory requirement for track and trace. Additionally, based on PV’s performance on the first project, Performance Validation will be assisting the client in completing the serialization modifications on all remaining packaging lines.
For more information on this project or how Performance Validation may assist you with your serialization needs, please contact:
Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave
(317) 727-8495 Mobile