Developing an effective toxicology/quality assurance partnership. Improving quality, compliance, and cooperation

Area of Science:

• Pharmaceutical industry
• Quality management systems

Background:

• Toxicology and Quality Assurance (QA) are integrated yet independent at Eli Lilly.
• Both departments aim to deliver high-quality products efficiently.

Purpose of the Study:

• To discuss practical changes made as part of a Total Quality journey.
• To highlight the impact of a monitoring/metric and trend analysis program.

Main Methods:

• Implementation of a monitoring and metric program for key work processes.
• Trend analysis of work processes central to product delivery.

Main Results:

• Metrics indicate that implemented changes have led to a higher quality product.
• The integrated approach to quality assurance and toxicology has been successful.

Conclusions:

• Continuous improvement through monitoring and trend analysis is key to product quality.
• Practical changes within a Total Quality framework enhance efficiency and product quality.