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Drug GMP and CMC Updates In Brief: Guidance Advances on Several Fronts

 
• By Bowman Cox

The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.

guidance advances
fda guidance advances • Source: Shutterstock

The US Food and Drug Administration has proposed and finalized several guidance documents that improve and clarify review and inspection processes.

Among these, the agency's internal guidance on preapproval and surveillance inspections now conforms to recent guidance to industry; guidance on...

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