Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020

FDA discusses post approval changes related to manufacturing process and facilities during the continued process verification stage, including modifying the approved manufacturing process, adding or removing a manufacturing line, replacing the current equipment with a new equipment, and changing of manufacturing site/location. Examples are given for each change and FDA shares the appropriate type of submissions (PAS, CBE0, CBE30, or Annual Report) that would be typically expected based on the changes.
Presenter:
Rose Xu, Quality Assessment Lead (Acting)
Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER
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