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.
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Based on industry feedback from pilot programs, agency proposes for discussion a layered approach to quality metrics reporting that industry sectors and individual manufacturing facilities could tailor to their needs.
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.