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FDA Quality Metrics for Drug Manufacturing

For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data may lead to higher levels of safety, efficacy, delivery, and performance.

Quality metrics are used throughout the drug and biological product industry to monitor processes and drive continuous improvement efforts in manufacturing. Effective use of quality metrics is one characteristic of robust site Quality Management Maturity (QMM).

Why are Quality Metrics Important?

  • The minimum standard for ensuring that a manufacturer’s products are safe, effective and of sufficient quality is compliance with current good manufacturing practice (cGMP) requirements.

  • cGMP compliance alone, however, does not indicate whether a manufacturer is investing in improvements and striving for sustainable compliance, which is the state of having consistent control over manufacturing performance and quality. Sustainable compliance is difficult to achieve without a focus on continual improvement.
  • An effective Pharmaceutical Quality System (PQS) ensures both sustainable compliance and supply chain robustness. Quality metrics can contribute to a manufacturer’s ability to develop an effective PQS because these data provide insight into manufacturing performance and enable the identification of opportunities for updates and innovation to manufacturing practices.
  • Quality metrics also play an important role in supplier selection and can inform the oversight of contract activities and material suppliers, as well as help determine appropriate monitoring activities to minimize supply chain disruptions. 
  • Quality metrics data from establishments can also have utility to the FDA.
  • Assist in developing compliance and inspection policies and practices.
  • Improve prediction and possibly mitigation of future drug shortages, while encouraging the pharmaceutical industry to implement innovative quality management systems for manufacturing.
  • Enhance FDA’s risk based inspection scheduling, reducing the frequency and/or length of routine surveillance inspections for establishments with quality metrics that suggest sustainable compliance.
  • Provide ongoing insight into an establishment’s operations between inspections.

How Can Quality Metrics be used at FDA?

The FDA implemented a Quality Metrics Reporting Program to support its quality surveillance activities. The FDA intends to analyze the quality metrics data submitted by establishments to:

- obtain a more quantitative and objective measure of manufacturing quality and reliability at an establishment;

- integrate the metrics and resulting analysis into FDA’s comprehensive quality surveillance program;

- apply the results of the analysis to assist in identifying products at risk for quality problems.

Reference: US-FDA

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