William Garvey

William Garvey is a validation consultant at Millipore Corp.

Fundamental validation skills related to heating, ventilation, and air conditioning must be thoroughly understood. Knowing the early history and development of validation is essential to understand the current set of regulations and standards governing the industry. This article reviews the history and outcome of contamination in large-volume parenteral drug products and discusses the qualification requirements of modern HVAC systems.

In the second half of this two-part series, the author suggests that to qualify and validate a pharmaceutical manufacturing facility, one must coordinate protocol and SOP development, scheduling and implementation, turnover package preparation, and the management and resolution of deviations and discrepancies. In combination with the programs described in Part I, these activities will help deliver projects on schedule, at estimated cost, and with quality assured.

To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, labor and cost estimating, and master-plan development.These activities, properly implemented, help deliver a validated facility on schedule, at the estimated cost, and with expected quality.