The Quality Lowdown: More Concerns Raised About API Plants, Data Integrity And Sterility Assurance

Recent enforcement activities shed light on compliance challenges at ALI, UCB, Novo, Samsung, Nectar, Panacea and Beximco.

The Quality Lowdown

A focus on active pharmaceutical ingredients, data integrity and sterility assurance was evident in inspection reports, an untitled letter and a warning letter that the US Food and Drug Administration recently published, as well as a recent EU GMP noncompliance report.

The agency disclosed a drug GMP warning letter 31 October that focused on control of porcine ingredients for prescription hypothyroidism treatments, unusual in that of late, most drug GMP

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