Quality Metrics or Metrics is a tool that is used by the FDA for inspections of products that follow certain compliance practices and regulations. It helps the FDA evaluate and compare metrics of each product and also make comparisons between manufacturing sites and plants.
Quality Metrics is often very useful in the Pharmaceutical, Drug and also in biological companies. It helps them to monitor and painstakingly evaluate their quality management systems to ensure that they are in sync and comply with standards set by regulatory bodies. Metrics also ensure that the operational processes of these industries are maintained, conforms to standards and that there is a continuous passion for improvements in the manufacturing of products.
This system also accommodates other vital elements in production like Supplier Performance, Customer Satisfaction, manufacturing defects, and cycle time frames. The FDA Quality Metrics encourages and guides pharmaceutical drug manufacturers on the need to conduct regular evaluations and verification of their patient products.
There’s a set up underway by the Food and Drug Administration (FDA) to collate products and manufacturing plant-specific quality metric reports on time. It is believed that when this is done, there will be an efficient inspection platform which will also accommodate big companies with plenty of quality metrics data and hence reduce on-site inspections.
Quality metrics however, is a very vital component of an efficient quality management plan and are measurements basically used in ensuring that customers receive acceptable products and deliverables at acceptably high standards. It also helps the industries adopt a more safety and hazard free culture to avoid manufacturing issues or problems that the drug is not withdrawn from the marketplace.
In essence, Quality Metrics analysis will greatly help the FDA to identify the quality of products manufactured and also review performance of quality management and manufacturing facilities in order to meet the desired standards accordingly.
Quality Key Performance Indicators (KPI’s) in Pharmaceutical Manufacturing Operations
- Number of OOS Results (Out of Specifications), OOT results (Out of Trends) for products released and this ensures stability testing for the finished product which is invalid due to laboratory errors or other recurring issues
- Juxtaposing the number of batches rejected during the operational processes or after the manufacturing to the total number of batches originally manufactured
- Number of lot released vs. stability testing conducted for a product
- Number of lots attempted, pending or put on hold for more than 30 days on the last day that the time period elapses
- Total summation of product complaints or market complaints collated for the products that have been distributed.
- Report of the start and end of the time period within the data.
- It also includes the number of APRs (Annual Product Review) or (Product Quality Review) required for a specific product
- Quality Metrics software has been developed to properly integrate to 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 opportunities for ongoing improvements
If you would like to discuss how the AmpleLogic Quality Metrics software can help in your business, kindly contact us