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Focus On Equipment And Software For Validating Continuous Manufacturing Processes – FDA

 
• By Joanne S. Eglovitch

US FDA officials outline the agency’s expectations for validating processes for drugs manufactured on a continuous line and see growing interest among manufacturers in developing continuous manufacturing systems.

As pharmaceutical companies respond to FDA’s call for switching from batch to continuous manufacturing, the agency is sharing its expectations on interpreting its guidance on process validation when crafting applications to market continuously manufactured drug products in the US.

Just as agency officials in 2015 discussed control strategies for continuous manufacturing, now they are talking about the overall framework for validating continuous manufacturing processes. (Also see "FDA Tries...

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