FDA Resumes Quality Metrics Effort With Feedback And Site Visit Initiatives
FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.
You may also be interested in...
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
The US FDA used predictive analytics to mine data from 346 field alert reports to gauge the strength of manufacturers’ quality systems with the idea of using it to help set inspection priorities.