FDA's current Thinking on KPIs and Quality Metrics

FDA's current approach to overseeing pharmaceutical manufacturing emphasises the importance of quality metrics in ensuring product safety and efficacy. These metrics, which are an integral part of the FDA's inspection and compliance strategies, aim to promote continuous improvement and innovation within the industry. While the FDA focuses primarily on Quality Metrics, the concept of Key Performance Indicators (KPIs) also plays a critical role as it provides a broader perspective on operational efficiency and strategic management.

The effective use of metrics is essential for robust quality management at a site. They also play a crucial role in selecting suppliers, monitoring contract activities and minimising supply chain disruptions. The FDA itself uses metrics to develop compliance and inspection guidelines, improve the prediction and mitigation of drug shortages, and optimise risk-based inspection planning.

The FDA is also working on a Quality Metrics Reporting Programme to support its quality monitoring activities, with the goal of obtaining more quantitative and objective measures of manufacturing quality and reliability. In addition, the FDA's Center for Drug Evaluation and Research (CDER) is implementing a programme to promote Quality Management Maturity (QMM) in drug manufacturing facilities. The QMM programme promotes the adoption of quality management practices that go beyond CGMP requirements and aims to foster a strong quality culture, recognise advanced quality management practices, identify areas for improvement and minimise risks to product availability.

Key Performance Indicators (KPIs) are important metrics used in pharmaceutical manufacturing to measure and evaluate the effectiveness of operations and processes against defined goals. While the FDA emphasises quality metrics to monitor the product and process lifecycle in pharmaceutical manufacturing, KPIs can complement these by providing insights into compliance and operational efficiency.