Serialization

The Challenge

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.

The Solution

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:

  • Project Management:
    • Assisted the site project team in aligning documents to meet corporate expectations with minimal impact to cost and schedule.
    • Actively involved in project status meetings, monitored the schedule, and provided direction to the team on courses of action to take when issues arose.
    • Facilitated communications to the project stakeholders and communicated overall status of the project and state of documents to keep the project team aware of Commissioning and Qualification needs throughout the project.
    • Tracking each document in regards to budget, schedule, and quality.
  • Technical Expertise:
    • Worked with the client project team to define the scope and determining engineering documentation (commissioning and qualification) requirements.
    • Developed/updated project documents including the Qualification Plan, Classification Documents, Design/Requirement Documents, IQ/OQ/PQ, Failure Modes and Effects Analysis, Computer System Validation requirements, Qualification report, and Commissioning Documents.
    • Troubleshooting/ test failures, PV took a proactive role in identifying equipment issues which impacted qualification and the desired operation of the packaging equipment.
    • Problem resolution and tracking of open items, which allowed completion of the qualification with the remaining open items triaged according to risk and accepted by project stakeholders.
    • Qualification of a new and unique piece of packaging equipment that the client had no prior experience with.

The Results

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:

  • Modifying equipment on the packaging line to allow for serialized or non-serialized packaging.
  • Qualifying a Laser Vision Checkweigher and decommissioning the Carton Checkweigher that had previously been used.
  • Qualifying a new Casepacker on the line that included a Print and Apply Labeler.

The Benefits

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:

Brad Henry
Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave
Suite 100
Indianapolis, Indiana
(317) 248-8848
(317) 727-8495 Mobile