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The Quality Lowdown: Key Inspection Findings At Glenmark, Centrient, Lupin, Aurobindo, Mac-Chem

 
• By Bowman Cox

US and EU drug GMP inspections at API and drug product manufacturing sites in India found fault with investigations, process validation, data integrity and contamination prevention.

The Quality Lowdown

Inadequate investigations were a major focus of recent drug GMP inspections by the US Food and Drug Administration and EU national authorities that resulted in serious findings, with consequences so far of two FDA warning letters and two EU good manufacturing practices noncompliance notices.

Other key focus areas: process validation, data integrity

Quality Lowdown

The Lowdown is a recurring

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