What is Quality Metrics?

Quality Metrics in Regulatory Compliance

Quality metrics play a fundamental role in many industries, not just the pharmaceutical industry, and play a pivotal role in evaluating and improving processes, products and services. In the realm of regulatory compliance, these metrics gain even more significance, ensuring safety, efficacy, and consistent quality across products. In this article, we will delve into the world of metrics from a regulatory standpoint, exploring their definitions, relevance in different countries’ regulatory agencies, associated projects, benefits, and the systems that support their implementation.

1. Quality Metrics Definitions by Global Regulatory Authorities

Different countries’ regulatory agencies have recognized the importance of quality metrics and have provided their own definitions and guidelines. For instance, the U.S. FDA (Food and Drug Administration) emphasizes the measurement of quality culture, process capability, and product quality in their metrics initiatives. Similarly, the EMA (European Medicines Agency) emphasizes the importance of continuous improvement and risk management through quality metrics.

FDA defines Quality Metrics as : An objective way to MEASURE, EVALUATE and MONITOR the product and process lifecycle. and These data may lead to higher levels of safety, efficacy, delivery and performance.

2. Why are Quality Metrics important ?

cGMP compliance alone does not tell if a manufacturer is investing in improvements and working toward sustainable compliance, that is, consistently controlling manufacturing performance and quality. Sustainable compliance is difficult to achieve without a focus on continuous improvement. FDA is proposing to develop and implement a quality metric reporting program to support quality surveillance activities. So, By building systems related to this and analyzing indicators through these systems, complete quality can be achieved.

3. Benefits of Quality Metrics in regulatory compliance

• Proactive Risk Management
  Enable early identification of potential issues, allowing manufacturers to address them before they escalate.
• Continuous Improvement
  By analyzing metrics data, companies can identify opportunities for process optimization and enhanced product quality.
• Data-Driven Decision Making
  Regulatory agencies can make informed decisions based on data-driven insights, improving oversight and compliance.
• Resource Allocation
  Help allocate regulatory resources more effectively by focusing on areas that need greater attention.

4. How can Quality Metrics be used ?

• 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 (e.g., quality-related shortages and recalls)

• FYI(Excerpted from FDA)

How important the Quality Metrics !

In particular, it is important to have an IT/OT system to analyze A well in SMART FACTORY that manufactures pharmaceuticals

5. Related systems for quality metrics analysis

• Electronic Quality Management Systems (eQMS)
  eQMS platforms facilitate the collection, storage, and analysis of metrics data, streamlining regulatory reporting.
• Manufacturing Execution Systems (MES)
  MES systems provide real-time visibility into manufacturing processes, aiding in data collection for metrics. Also these system that can create important indicators and can well analyze the correlation between workers and the process.
• Data Analytics and Business Intelligence Tools
  These tools enable organizations to extract meaningful insights from metrics data, supporting decision-making.
• Warehouse Management Systems (WMS)
  WMS systems help collect data for metrics by providing real-time visibility into inventory or material movement processes.

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6. References