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Latest From Joanne Eglovitch
Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.
FDA has issued final guidance that allows outsourcing facilities to share the same physical address as traditional pharmacies as long as their operations are completely segregated. Draft guidance forbidding such co-location drew opposition.
Many of the six drug GMP warning letters the US FDA has issued since late March targeted lax testing practices, particularly at OTC firms abroad. Two EU GMP non-compliance notices highlighted data integrity shortcomings in India. FDA also posted a couple of Form 483 reports and added four facilities to its GMP import alert.