Hello,
It would depend upon the kind of product and impact of change on product's quality. Equivalency need to be demonstrated between products manufactured pre and post change, It can also be grouped along with site change, which by default is a major change.
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Deepa Dasgupta RAC
Director
Hyderabad
India
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Original Message:
Sent: 26-Dec-2019 13:21
From: Anonymous Member
Subject: Impacts due to Manufacturing Transfer/ Change
This message was posted by a user wishing to remain anonymous
Hello,
Can anyone help to understand what are the EU and US FDA regulatory impact due to manufacturing transfer/change of a product line?
Thanks in advance!