Clinical Trials Manufacturing – New Equipment Qualification

The Challenge:

A Contract Manufacturing Organization (CMO) anticipated needing additional capacity to produce pharmaceutical products for clinical trials studies and decided to order a new tablet coating pan system.  This million-dollar piece of equipment also required the installation of a new air handling system and industrial dust collector within a facility owned by a different company which necessitated coordination on facility construction.

The Solution:

Performance Validation provided technical resources with direct experience with tablet coating pan and air handling unit qualifications.  The Performance Validation Project Leader helped identify issues during equipment installation through receipt verification, installation verification, and functional testing commissioning activities.  Performance Validation helped facilitate communication between the facility owner, the construction contractors, and the CMO to ensure that potential roadblocks to project success were identified in a timely manner, and potential solutions were quickly identified, accepted, and implemented to keep the project on schedule.  The Project Leader ensured all documentation requirements were met for equipment qualification and developed a Computer System Validation package, which met the requirements of 21 CFR Part 11 for computer system security, data integrity, and user access.

The Results:

The equivalent equipment was installed, qualified, and released for production use in time to meet customer demands.  All end-user training, standard operating procedures, equipment maintenance procedures, and computer system security were completed and established during qualification to make the equipment ready for use immediately upon the completion of qualification testing.

The Benefits:

Performance Validation provided a complete documentation package for the entire Design, Installation, Testing, and Maintain lifecycle phases of the equipment and computer system which met the quality requirements of the CMO and their client.  The expertise provided by the Performance Validation project team helped drive project completion by quickly identifying and resolving issues, thus allowing the project team to focus on activities required to complete the months-long project.

For more information:
Kristin Beckman
Senior Validation Specialist
Performance Validation, LLC
Cell: (317) 490-2381