Quality Metrics for Pharmaceutical Manufacturing : Pharmaceutical Guidelines

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Quality Metrics for Pharmaceutical Manufacturing

Quality Metrics are used to monitor the overall quality of the pharmaceutical products. It also helps to improve the product quality and implementing the quality culture in the manufacturing acility.
Quality metrics are the essential components of effective and efficient quality management plans in pharmaceuticals. They are the measurements used to ensure that the customers in the pharmaceutical industry receive acceptable deliverables or products. They are useful in translating the needs of the customers into performance measures that are acceptable for both the manufacturing processes and the products.

Usefulness of Quality Metrics in the Pharmaceutical Industry

The major role of quality metrics for pharmaceutical manufacturing is to drive continuous improvement efforts and monitor quality systems and processes when manufacturing drugs. It is worth for you to understand that the quality metrics are the systematic and refined representation of all the quality manufacturing operations.

Quality Metrics
Pharmaceutical companies are controlled and directed by the Pharmaceutical Quality System in terms of quality. The system provides oversight and assurance which are the key elements necessary for controlling the laboratory processes and the pharmaceutical manufacturing processes throughout the life of the products from when the products are developed to when they are sold.

FDA has done an observation of data which demonstrates that adoption of quality measurement programs helps pharmaceuticals to improve the quality of their performance. Among the research findings that might be very helpful to you are those found by FDA in collaboration with St. Gallen University. The research found that;
  • Quality metrics are helpful in informing the scheduling of risk-based drug manufacturing in the and developing compliance with inspection policies.
  • Quality metrics are useful in improving the ability of the manufacturers to mitigate the shortages of drugs in the future because it is possible to predict the needs of the customers.
  • Quality metrics for pharmaceutical manufacturing encourage the innovation of total quality management systems as well as the implementation of the state-of-the-art systems in the pharmaceutical industry.
  • They help in ensuring that all patients receive high-quality, effective, and safe medications.
  • They help in solving all the quality issues that might result in harming the patients.

Quality metrics enables the manufacturers to make timely and sound decisions, set strategic visions, missions, and plans, however, the manufacturers should;
  • Ensure electronic reporting and sharing of data.
  • React as quickly as possible to any problems that might arise during the manufacturing process.
  • Develop procedures that should help them to maintain the quality metric systems.
Now we have looked at the quality metrics for pharmaceuticals you might be asking yourself, what are the key features of quality metrics? Let's conclude this article by looking at and listing the key features of quality metrics.
  • They are used to validate the manufacturing processes in pharmaceuticals.
  • They help in determining and assessing the manufacturing quality attributes and process parameters.
  • They help in the continuous improvement of pharmaceuticals.
  • They help the manufacturers to process data, evaluate drugs quality and maintain products.
FDA Quality Metric Research Report Year 1
FDA Quality Metric Research Report Year 2





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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