Facility Validation: A Case Study for Integrating and Streamlining the Validation Approach to Reduce

Pharmaceutical companies typically require considerable resources, in terms of time, money, and specialized personnel, to validate a current Good Manufacturing Practice (cGMP) facility. This can be overwhelming to a small company or plant with limited resources. This paper identifies some of the key areas in a facility upgrade project that have been found to result in inefficiencies, project, and facility start-up delays. It seeks to demonstrate that the integration and streamlining of the design, construction, commissioning, and validation phases can accelerate the start-up effort, reduce the validation effort and costs, produce superior documentation, and ensure that product is produced in a cGMP-compliant facility. It will also prove that even though the original focus of validation was to satisfy regulatory expectations, facility validation has in fact become good business and engineering practice that enhances reliability, cost, and quality of the products.


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Author(s):

Graham C. Wrigley,Pfizer Global Manufacturingand Jan L. du Preez, Ph.D.Research Institute for Industrial Pharmacy

Journal:

Journal of Validation Technology,Volume 8 Number 2 February 2002