Benchmarking BioPharma Quality and CAPA Processes

Best Practices, LLC recently undertook a study to assist companies in achieving top-tier performance in three important areas critical to Quality: CAPA Process Management, CAPA Performance Benchmarks and Quality Resource Management. This study will serve as a benchmark for Quality leaders in building a strong CAPA system and thereby developing a robust quality function, within tight budgets.

Study Snapshot

This benchmarking study engaged 14 executives from leading biopharmaceutical organizations. Data
is charted throughout this report for the “Total Benchmark Class” (TBC) as well as for the “Large Company Segment” (LCS), which includes 9 companies with biopharmaceutical revenues above $5B.

Key Findings

Quality Spend & Staff Levels and Trends: Complexity factors, regulatory restrictions and process management factors are the top areas that effect Quality resource levels. To ensure lower costs, companies must manage the factors that they can have high control on.

Quality Spend Mix:  Benchmarked companies have a critical improvement area for allocating higher percent of their quality budget to prevention and this change may decrease budget allocated to appraisal activities and external failures.
Quality Reporting and Ownership:  It’s important for companies to align quality ownership with quality budget management.  As the functions that have the ownership of quality activities obtain more financial resources and responsibilities, budget allocation to several activities will be more effective.