FDA's oversight of the pharmaceutical manufacturers quality operations continues to evolve into a strategic, risk-based approach to inspections.
In 2015, the Office of Pharmaceutical Quality was established to improve the quality of a drug product throughout the life cycle, which includes new, generic and over the counter drugs.
In this whitepaper, we examine the factors that led the FDA's Request for Quality Metrics draft guidance including:
- Increased pressures to improve the safety & availability of the nation's drug supply
- Potential quality metrics that will be used
- Technology solutions that will ease the metrics gathering burden