PFAS exposure for device manufacturers no longer hinges on a single rule or a single material. FDA has drawn a firmer line around fluoropolymers, yet state reporting requirements, a still-evolving EU ...

Regulatory exemptions for essential PFAS uses in pharmaceuticals can create a false sense of security. Reporting duties, wastewater and solid waste obligations, CERCLA liability, and a major ...

Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations ...

Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to ...

Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect ...

Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between ...

Proposed changes to the EU MDR could eliminate the standalone post-market clinical follow-up (PMCF) evaluation report and relax reporting cadences. The proposal shifts the question from which report ...

A single swap, say a fluoropolymer gasket or filter, can force requalification, validation and refiling. Fluorine sits in a meaningful share of APIs, and fluoropolymers run through tubing, stoppers, ...

Compendial standards rarely change without consequence for testing laboratories, and the recent revision to USP <788>, Particulate Matter in Injections, is no exception. Written by Lori Graybill, ...

For years, manufacturers relied on a table-based approach to determine allowable ethylene oxide residual limits, an approach that didn't adequately account for vulnerable patient populations or device ...

Many drug–device combination products can be developed to achieve the therapeutic goal and still face significant challenges in the manufacturing phase. Laboratory performance might be different from ...