| Closure of individual pharmaceutical manufacturing facilities is a frequent event and often occurs over several years. Closure of a facility brings about additional quality challenges for which effective leadership, risk management, and quality planning are essential to manage. This project describes the difficulties encountered during closure including those involving human resources, facility and equipment maintenance, and quality of supplied materials, and considers them with respect to risk to product quality and potential harm to the consumer. Methods for conducting risk assessment and strategies for mitigating the risk during a time when resources are limited are discussed. The project provides examples of risk assessment and a recommended quality plan for a closing pharmaceutical facility. |
