Commissioning and Qualification of Utilities in a new Filling Line Expansion Project

Abstract

As part of a project for a Parenteral Filling Line expansion, Commissioning and Qualification activities were performed in new and existing modified systems to provide documented evidence and ensure that all equipment, utilities and facilities were in compliance with all regulations and GMP requirements. During this project, the Define, Measure, Analyze, Improve and Control (DMAIC) methodology were used to shorten the process and execution time of Commissioning and Qualification in two (2) utilities systems. The scope of this project is limited to the Commissioning and Qualification (IQ & OQ) of the Water for Injection (WFI) Generation and Clean Steam Generation utilities. Additionally, the Process Performance (PQ) Qualification is out of the scope of this project. The project consisted on the improvement of the Commissioning and Qualification process by reducing the amount of test cases, and executions during the Operational Qualification (OQ) phase by using a leveraging strategy making the process more efficient. One (1) Commissioning protocol and One (1) combined IOQ (Installation Qualification and Operational Qualification) protocol were executed for each system, which included eighty-two (82) test cases and four (4) summary reports. A total of sixteen (16) deviations were generated including six (6) retest executions related to protocol errors, error in design documents and equipment failure. Key Terms - Commissioning, Deviation, Leveraging, Qualification.