Quality Metrics

(QMS) Quality Metrics Software

Quality Metrics, often known as Metrics, is a tool used by the FDA to inspect products’ adherence to specific compliance standards and laws. It assists the FDA in appraising metrics for each product, as well as making comparisons between production sites and facilities.

Usually, Quality Metrics are quite beneficial to the pharmaceutical, drug, and biological industries. It assists them in monitoring and meticulously evaluating their quality management systems to guarantee that they are in line with the criteria of regulatory authorities. Metrics help guarantee that the operating procedures of these industries are maintained and, and that there is a constant desire to advance product manufacture.

This system also cares for other critical production aspects such as Supplier Performance, Customer Satisfaction, manufacturing defects, and cycle time frames. According to FDA Quality Metrics, pharmaceutical companies should undertake routine assessments and verification of their patient goods to stay on top of the latest developments in their field.

Currently, the Food and Drug Administration (FDA) is working to compile timely quality metric data relevant to products and production plants. Assuming this is completed, an effective inspection platform will be created that can handle large organizations with a wealth of quality metrics data and, as a result, minimize the number of on-site inspections required

To ensure that consumers get acceptable products and deliverables that meet approved standards, quality metrics play an important role in the overall quality management plan. It also assists companies in adopting a more safe and risk-free culture to avoid production issues or problems that result in the medicine not being pulled from the market.

For the most part, Quality Metrics analysis will assist the FDA to recognize high-quality goods and evaluate the performance of quality management and manufacturing facilities to achieve the required requirements.

Quality Key Performance Indicators in Pharmaceutical Manufacturing Operations

  • Several OOS (Out of Specifications) and OOT (Out of Trends) findings for goods are provided, ensuring that stability testing for the completed product is not incorrect because of laboratory mistakes or other persistent issues.
  • A comparison between the total number of batches initially created and the number of batches rejected during operational procedures or after production
  • Tests of the number of lots issued against the stability test performed on a product
  • The number of lots tried, pending, or placed on hold for a duration of greater than 30 days on the final day of the period
  • The summation of all product or market-related complaints about distributed products are compiled
  • Report on the beginning and end of the period as contained in the data
  • The amount of APRs (Annual Product Reviews) or PQRs (Product Quality Reviews) that a particular product requires
  • AmpleLogic’s GMP Quality Metrics software has been designed to combine seamlessly with CAPAs (Corrective and Preventive Actions)
  • OOS rates by location, the computed rate of OOS confirmed products acquired from the production facility
  • The rate of product recalls, evaluated number of verified out-of-spec findings calculated by the total number of specification tests
  • Taking care of customer compliance mechanisms and product recalls
  • Noncompliance findings and audit observations
  • The acceptance rate of lots
  • Departures from standard operating procedures (SOPs) are spotted using quality metrics software
  • AmpleLogic Pharma’s Quality Metrics Software will provide the projected percentage of CAPAs planning that occurs during training

The Proposed Quality Metrics Reporting Software will help with:

  • The process of finding and fixing issues in manufacturing quality control.
  • Quality metrics data from companies will be used by the FDA to build better compliance and inspection policies and practices, which may improve the forecast accuracy of concerns and prevent future drug scarcity in the market.
  • Allocating the necessary inspection tools to firms at risk of noncompliance.
  • Ensure the use of cutting-edge IT systems and resources, as well as novel quality management methods.
  • Providing guidance and develop best practices and standards on risk-based scheduling for drug manufacturing facilities so that inspection frequency can be reduced.
  • Encouraging consistent improvements in policies and procedures in their operational excellence to provide higher-quality products.
  • Data reporting aids FDA in segmenting and assisting top performers, as well as addressing potential drug shortage concerns in the future.
  • Significantly contributing to root cause analysis as well as an origin of mistakes, and highlights areas for improvement.

TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH electronic record requirements will also be met by AmpleLogic Pharmaceutical Quality Metrics and Quality Index Software.

Quality Metrics - Facility Index Report
Facility Index Report

Please get in touch with us if you’d like to learn more about how AmpleLogic Quality Metrics Software may benefit your company.