Requalification Initiative for
Multi-Dosage Pharmaceutical Manufacturing Facility
Location: San Antonio, Texas
Timeline: November 2021 – Present
Project Summary
Compli provided experienced CQV personnel to support a comprehensive requalification initiative for a large-scale, multi-dosage Contract Manufacturing Organization (CMO) facility. The scope of the project encompassed critical utilities and equipment supporting aseptic liquid, liquid, semi-solid and solid dose forms. This work was completed over a two-year period while the facility remained fully operational.
Project Scope and Execution
As part of a multidisciplinary team, Compli was responsible for developing and executing requalification protocols, managing deviations and discrepancies and preparing final summary reports. The requalification efforts were initiated after the facility identified that many equipment and system qualifications no longer met current regulatory standards or internal validation requirements.
Key Contributions and Outcomes
Compli developed detailed requalification protocols aligned with current Good Manufacturing Practices (cGMP) and the client’s internal quality systems. These protocols were executed with precision to minimize disruptions to ongoing production schedules. The team also provided thorough documentation of discrepancies and deviations to ensure regulatory compliance and supported the effort with comprehensive summary reports for each system and piece of equipment requalified.
Challenges and Approach
Maintaining full operational status during requalification efforts was a significant challenge. Compli’s team demonstrated flexibility by adjusting work schedules and dedicating evening and weekend hours as needed to meet critical timelines. This proactive and responsive approach ensured minimal disruption to facility operations and contributed to the timely completion of project phases.
Our Involvement
Compli’s involvement was driven by the depth of experience among its personnel and a proven track record in CQV services. The team’s technical capabilities and ability to integrate seamlessly with the client’s multidisciplinary team were key to the project’s success.