A large mid-western pharmaceutical company planned to upgrade their Manesty, HATA, and Korsch Tablet Presses (30 Presses total) with a Tablet Press Automated Controller (TPAC) to better control the manufacturing process and provide user security levels and functionality along with a standardized operator interface. An additional challenge is that during the project innovations, improvements, and new ideas were evaluated, and if desired included in the final project.
Change Control – Performance Validation managed the Change Control process for the client and tracked each implemented change to ensure that all upgrades were captured in each subsequent iteration of the qualification protocol. This was a critical function as improvements/changes were made to the upgrade such that not all upgraded presses were identical.
Coordination Client & Vendor – Performance Validation worked with the client engineering, operations and maintenance departments along with the TPAC vendor to smoothly integrate and test improvements with the design and function of the TPAC.
Factory Acceptance Testing – Performance Validation supported multiple FATs for the client at the vendor’s site so that the changes being made could be captured and tested correctly.
Protocol Development and Execution – Performance Validation ensured successful completion of the project on time and within budget by providing and managing the resources for development and execution of the IQ/OQ and PQ documents.
Common Configuration & Final Testing – Once the final tablet press was completed, all other tablet presses were brought to the same standard and retested; Performance Validation worked with the vendor and client to ensure that each tablet press was tracked as to its original configuration so that the correct updates could be applied and a final validation protocol executed.
Performance Validation completed the project on time and within budget for the customer.
All Tablet Presses were successfully upgraded with a standardized TPAC that provided the customer with improved performance, better management, and data logging/reporting for their tablet press operations.
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Michigan Division Director