1. Pink Sheet
  2. >>Compliance

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, said the FDA’s Jennifer Maguire, who reported on the results of the two programs at the 15 March Pharma Link conference sponsored by the FDA and Xavier University in Cincinnati, held virtually due to the pandemic

More from Manufacturing

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Compliance