Abstract

QUALITY METRICS: ADEPTNESS PROVOKING PRACTICE

Rasika Walunj* and Suhas Joshi

ABSTRACT

Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be used by FDA to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers to improve the Agency‘s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing .This article includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry to help move towards a desire state and Path to achieve regulatory flexibility and reduced post market change control burden.

Keywords: Quality metrics, Risk Management, Quality, Manufacturing, Post Market.