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The Quality Lowdown: Corporate Culture And Site Complexity Can Pose Challenges

 
• By Bowman Cox

Quality and the measure of a firm: Toyobo’s particulates and resins, Galenicko’s sanitation, Breckenridge’s product chemistry and Fujifilm’s cross-contamination risk.

The Quality Lowdown

Several recent inspections of pharmaceutical manufacturing facilities reflect two key factors in quality: corporate culture and facility complexity.

The US Food and Drug Administration found signs of a poor quality culture at a pharmaceutical plant in Japan that exhibited data integrity shortcomings and repeated failures to resolve problems with particulates in sterile injectables

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Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
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