Challenge
Pfizer is the world’s largest biopharmaceutical company. To maintain their leadership position, Pfize invests heavily in keeping its support systems current with the industry standards. Continued research requires regular expansions and renovations of facilities to accommodate new equipment and new processes needed by their scientists. Pfizer maintains relationships with commissioning and validation firms to support the requirements of these efforts; Hallam-ICS is one of these firms, having worked with Pfizer on a continual basis since 2003.
An example of a recent validation project was the replacement of a Good Manufacturing Practice environmental monitoring system. The GMP monitoring system monitors, trends and alarms the environmental conditions such as temperature, relative humidity and differential pressure in Pfizer’s Solid Dosage Manufacturing and Inventory Management business lines. The existing monitoring system was replaced by a new GMP monitoring system which provided a more reliable and redundant system. The installation required that a new computer systems and new software to be installed and implemented.
Solution
Hallam-ICS provided the Validation services for this project. One of the major challenges of this work was completing the removal of the existing monitoring system, installation of new controls equipment and network, and validation of the entire system which includes instrument calibrations, training of the system users and archiving of the existing data. These activities were performed during phases of downtime within the facility. This challenge was addressed by developing a detailed phased validation approach that focused on strategic timing of validation activities and implementation of the new monitoring system within the building. Hallam-ICS worked closely with the Pfizer quality authority, Pfizer building management team and the process controls system vendor to insure that all validation activities were addressed and scheduled according to the project’s phased timeline.
The final validation deliverable package included a Hardware/Software Specification, a User Requirements Document, Project Validation Plan, Installation and Operational Qualifications, and Validation Final Report. Hallam-ICS was able to develop the entire qualification package and deliver a completed product that met the requirements for this project.
