Quality Metrics

Quality Metrics

Quality Metrics or Metrics especially helps the FDA to develop and use inspection and compliance practices, use to evaluate and compare metrics of each product and manufacturing sites or plants respectively.Quality Metrics has widely used in the Pharmaceutical, Drug and also in biological companies need to monitor, evaluate their quality management systems and their operational processes.


Drive the strategy and direction of the organization.
Provide focus for an organization, department or employee.
Help make decisions.
Drive performance.
Change and evolve with the organization.
Produce good internal and external public relations.

Quality Key Performance Indicators

Number of OOS Results (Out of Specifications), OOT results (Out of Trends) for a lot of release and stability testing for the finished product which is invalid due to laboratory errors or issues.
Number of batches rejected during the operational processes or after the manufacturing compared to the total number of batches produced.
No. of lot release vs stability testing conducted for a product
No. of lots attempted, pending for more than 30 days on the last day of the time period
Sum of product complaints or market complaints received for the distributed products.
Start and end of the time period within the data are reported.
Number of APRs (Annual Product Review) or (Product Quality Review) required for a product.