PDUFA’s ‘Huge’ GMP Change Will Tie Adulteration To Quality System
Legislative language would consider a drug adulterated if it does not have the necessary quality management systems in place as required in current Good Manufacturing Practices.
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The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”
OGD Director Geba says generic manufacturers still suffer from extensive quality problems, but GPhA officials argue the industry is doing fine and communications with the agency need to be more uniform.
The user fee legislation U.S. Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains.