Article

Quality Metrics: How To Add Value And Meet The FDA's Expectations

Source: Ropack Pharma Solutions

By Cheryl Abernathy, Quality Assurance Operations Manager, Ropack Pharma Solutions

FDA quality metrics

Cheryl Abernathy, Quality Assurance Operations Manager, Ropack Pharma Solutions

In the pharmaceutical industry, “Quality Metrics” can be defined as the measures used to assess the quality of drug manufacturing.  Metrics are one way that an organization can provide assurance to customers, stakeholders, and regulatory authorities that their regulated products are not only safe and effective, but that they are also manufactured utilizing high-quality standards.

Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. However, the task of selecting the right metrics to incorporate has always been a bit of a challenge as quality can be subjective and hard to measure in a meaningful way. 

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