Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals. It prescribes a sequence for life sciences companies and contractors to improve and demonstrate process quality control and understanding.
To help readers prepare for this new regulatory focus, this article will:
- Highlight the four key quality metrics recommended in the draft guidance
- Describe how companies can implement manufacturing quality metrics (MQM) initiatives, such as building quality monitoring into processes and establishing more collaborative relationships with contractors through better report creation, editing, tracking, auditing, archiving, and retrieval
- Illustrate the patient, regulatory compliance, and business benefits forward-thinking pharma and bio companies already have gained through industry best practices for demonstrating process control.