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Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

 
• By Joanne S. Eglovitch

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

Pharmaceutical and Medicine Manufacturing - Pharmaceutical Workers - Collage Photo. Pharmaceutical industry photo collage showing workers at work on production of medicines in pharmaceutical factory.
US FDA Urged To Adopt Site-Based Metrics, Discourages Lot Acceptance Rates • Source: Shutterstock

Pharmaceutical manufacturers who took part in the US Food and Drug Administration’s recent quality metrics site visit and feedback programs advised the agency to adopt site-level reporting over product-level reporting and warned against using lot acceptance rates and invalidated out-of-specification results, saying they do not adequately discriminate between high- and low-performing sites.

Instead, the agency was urged to use other metrics such as right-first-time rate, process capability, and adherence to lead time,...

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