Regulatory oversight for drug manufacturing has significantly increased due to product quality issues in the pharmaceutical industry. This can be attributed to significant growth of new drug applications with broadening global sourcing and distribution. In this environment, Field Alerts Reports and Drug Product Recalls have been on the rise. FDA’s Quality Metrics initiative is focused on correcting this trend while at the same time providing a mechanism to reduce the burden and frequency of inspections based on risk.
Today, many companies use disparate systems to manage risk due to mergers and acquisitions increasing the level of data management complexity. In this environment, data needs to be pulled from several systems in order to gain the full picture of quality metrics. Manufacturers need to harmonize the data into one single source of truth.
With these challenges in mind, the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) released the technical specifications document for Quality Metrics in June 2016. The quality metrics initiative is to promote proactive quality management behavior to deliver better quality and safer products. This will be done by collecting quality metrics from pharmaceutical manufacturers with the goal of higher quality drug production without the requirement of extensive regulatory oversight.
The infographic below highlights the importance of measuring the right quality metrics, the challenges associated with capturing that data and leveraging a quality management system to track and manage those metrics to achieve your quality goals.
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