Latest Warnings Resulted from Lack of Lab Controls, Procedures, Investigations
This article was originally published in The Gold Sheet
Latest warning letters target lab controls, procedures, investigations.
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The Obama administration’s FDA continues to deliver on its promise of swift and aggressive enforcement of drug GMP requirements that it pronounced two years ago.
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.