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 and drive to have continuous improvement in the manufacturing drug products.
However, it includes other elements like Supplier Performance, Customer Satisfaction, manufacturing defects, and cycle time frames. The FDA Quality Metrics explains clearly gives guidance to encourage pharma drug manufacturers to conduct required evaluations of their patient products.
The Food and Drug Administration( FDA) plans to collect product and manufacturing plant-specific quality metric reports in advance or initial phase of inspection and for companies with plenty of quality metrics data which will reduce on-site inspections
Accordingly, Quality Metrics is the systematic representation of quality manufacturing operations and can ensure assurance to customers, stakeholders and regulating authorities’ that their products are manufactured by utilizing the high-quality standards.
And be more safety culture to avoid manufacturing issues or problems that the drug is not withdrawn from the marketplace.
Quality Metrics analysis will help the FDA to identify the quality and review performance of quality management and also manufacturing facilities meeting the desired standards accordingly.
There are set of quality metrics objectives, which would be reported to inform and support their risk-based inspection programs by choosing the data and seeking for feedbacks from a metrics to assist in the evaluation of the quality of product manufacturing throughout their product life cycles.
Quality Key Performance Indicators (KPI’s) in Pharmaceutical Manufacturing Operations
- 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
- Quality Metrics software will find out over dues of CAPA’s (Corrective and Preventive Actions)
- Out of Specifications (OOS) rates by site, the calculated rate of OOS confirmed products obtained from manufacturing plant facilities.
- Product recalls rate, calculated confirmed Out of specifications results per total no of specification tests
- Handling customer compliant mechanism and if any product recalls
- Audit Observations and noncompliance reported
- Lot acceptance rate
- Quality Metrics Software results deviations from instructions laid down in SOP’s
- AmpleLogic Quality Metrics Software will indicate the estimated percentage of CAPAs planning that is involved in training
The Proposed Quality Metrics Reporting helps to
- Identify and address the problems in the quality management of the manufacturing operations
- FDA will use the quality metrics data from industries to develop improved compliance and inspection policies and their practices which may help in predicting risks to quality and reduce future drug shortages in the market without failure
- To allocate the required inspection resources towards the companies at the risk of noncompliance.
- Ensure to implement the state of art of IT Infrastructure or resources, and innovative quality management systems.
- Ensure to develop best practices and policies, and inform risk-based scheduling of drug manufacturing sites which can result in a decrease in inspection frequency.
- Support continuous improvements in the policies as well as practices in their operational excellence to provide better quality products
- Data reporting helps FDA to segment and support high performers, address future drug shortage issues
- Provides inputs for analyzing root cause and also a source of errors, identifies Opportunites for ongoing improvements