New Study Presents Insights into Creating and Maintaining an Effective Quality Function within Pharmaceutical Companies

18 Dec, 2015, 15:24 ET from Best Practices, LLC

CHAPEL HILL, N.C., Dec. 18, 2015 /PRNewswire/ -- Biopharmaceutical companies spend millions to ensure their products meet quality standards at every stage of the product life cycle, from R&D to post-market activity.

Facing tight budgets and escalating regulations, quality leaders walk a tight rope in balancing quality and safety while managing costs and assessing risk. In addition, it is important to identify and standardize the best path for CAPA processes to evaluate and investigate deviations successfully. Those that fail to balance priorities and create a strong CAPA process are under greater risk of marketplace failure and regulatory scrutiny.

Research and consulting leader Best Practices, LLC undertook a new study to benchmark how companies define and allocate quality spend, identify factors that impact spending levels, and describe the best metrics and pathway to create strong CAPA processes.

A well-defined CAPA system is essential for any biopharmaceutical company to drive quality improvements across the organization. Hence, it is imperative for biopharmaceutical organizations to measure the effectiveness of their CAPA processes to identify potential areas of improvement in their quality function. The study found that more than half of the participants use "Number of Recurrences" and "Number of Repeats" to measure the effectiveness of their CAPA processes.

This study will assist companies in achieving top-tier performance in three important areas critical to quality: CAPA Process Management, CAPA Performance Benchmarks and Quality Resource Management.  "Benchmarking BioPharma Quality and CAPA Processes" will serve as a road map for quality leaders to use as they build a strong CAPA system and establish a robust quality function, within tight budgets.

Some of the issues addressed in this research include:

  • Assessing CAPA processes
  • Uncovering strong benchmarks for CAPAs, NCEs, FDA Questions, Inspections and Observations
  • Defining CAPA effectiveness metrics
  • Measuring the true cost of Quality
  • Highlighting strategies to manage quality costs and align spend mix

The full 73-page report contains more than 400 metrics, providing quality leaders with critical benchmarks that will allow them to compare their operations with those of leading organizations.

Best Practices, LLC engaged 14 executives from leading biopharmaceutical organizations for this research study.

To access the full report or to download a complimentary summary containing insights found in this report, click on the following link:

For related research, visit our Best Practices, LLC Web site at

Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.

SOURCE Best Practices, LLC