Pharma R&D Quality Assurance: Staffing and Use of Risk-Based Approach Programs

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"Pharma R & D Quality Assurance: Staffing and Use of Risk-Based Approach Programs"

Study Overview:

This study is aimed at helping pharmaceutical R&D Quality Assurance executives tackle two current challenges: optimizing limited QA staff resources and implementing Risk-Based Approach guidelines for GxP oversight. This study identifies ratios of QA organization size relative to the size of the R&D functional areas they serve. Organizations are also evaluated on their level of Risk-Based Approach and its impact on QA workload and management.

QA leaders can use this 39-slide presentation to gauge their staffing levels as well as FTE distribution across the GCP, GLP and GMP functions. They will also get a look at where pharma companies are today in preparing for risk-based assessment.

Key Metrics and Topic Areas:

• Average ratio of R&D QA employees to all R&D employees supported
• Optimal QA staffing distribution by function, including GMP, GLP, GCP, Pharmacovigilance QA, API, Inspections Administration
• Percentage of total QA employees staffed to various R&D functional roles (e.g. clinical research, manufacture of API for clinical trial use, etc.)
• Optimal ratio of QA supervisors to QA front-line staff
• Average percentage of R&D activities that are outsourced
• Risk-Based Approach implementation of each benchmark partner: tools, application and impact

Sample Key Findings:

• The QA to R&D Activity staffing ratios demonstrate that quality oversight resources for each pharmaceutical R&D activity vary widely from company to company.

• Most companies are carrying their implementation of Risk-Based Approach into each GxP area. However, these companies commonly characterize their implementation of Risk Based Approach in different QA areas as “Under Development,” indicating that formal RBA programs are relatively new.

• Based on survey responses and descriptions of formal Risk-Based Approach implementation programs, most companies appear to have a greater understanding of how RBA can be used in GMP and GLP oversight, but have less understanding of its application to GCP.

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