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"Pharmaceutical Company Profiles of Using Risk-Based Approaches in Drug Development"
As the FDA transitions into using a Risk-Based Approach auditing method for inspecting the operations of pharmaceutical companies, many industry leaders are realizing the benefits of using the same model when tracking internal Quality Assurance. This research document is drawn from a larger study, Pharma R&D Quality Assurance: Staffing and Use of Risk-Based Approach Programs (#4884), commissioned to understand the effective practices of Quality Assurance at major successful pharmaceutical companies.
This larger study includes the same six slides included in these profiles on Risk-Based Approach implementation levels, but the vast majority of the study focuses on metrics for Quality Assurance areas, including GMP, GLP, GCP and validation.
These profiles are designed to give pharmaceutical managers, directors and executives an understanding of how RBA is used and whether or not their company is at par with the advanced approaches used by industry leaders and their pharmaceutical peers.
Included in this document are six blinded profiles of leading companies, drawn from a benchmark class of Abbott, Boehringer-Ingelheim, Eli Lilly, Johnson & Johnson, Novartis and Wyeth.
Key Metrics and Topic Areas:
Profiles include slides of the tools, application and impact of each companies' Risk-Based Approach implementation, along with one to two pages of details describing the following elements:
1. Status of RBA
2. Quality Assurance Tools Used
3. Scoring System
4. Risk Parameters
5. Impact of RBA
6. Information Sharing
7. Perspective on ICH Guidance Q9
A portion of the Introduction to these profiles is shown below:
Sample Key Findings:
- All executives interviewed indicated they always used a risk-based approach to decide how to best apply limited resources, but their guidelines have been informal, inconsistent, and not standardized across the company.
- Most see Q9 as a positive step, although some commented that the guidance needs more detail.
- Some of the companies have already realized gains from their RBA efforts including cost savings, cost avoidance and the ability to do additional work without increasing staff.
Best Practices, LLC conducted surveys and follow-up interviews with six leading pharmaceutical companies. The study was completed for a Global Benchmarking Council member.