Quality Systems

Quality System Tweaks Necessary to Meet Final Combo Product cGMP Rule

Quality System Tweaks Necessary to Meet Final Combo Product cGMP Rule

By Zachary Brennan

The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to comply,...

New FDA guidance on cGMP

New FDA guidance on cGMP

By Gregory Roumeliotis

Drug manufacturers can better understand how they can achieve
regulatory compliance and avoid production stoppages and recalls by
following new guidance issued by the US Food and Drug
Administration (FDA).

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