Streamlining Postapproval Submissions Using ICH Q12 & SCDM
ISPE
AUGUST 29, 2022
Depending on the nature of the change, manufacturers may be required to maintain both the pre-and post-change equipment, processes, or methods until all approvals are received. Published November 2019. Published November 2019. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. 5 Ahluwalia, K.,
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