A change in an API manufacturer is
minimally a site change. FDA recommends that a move to a different manufacturing site, when it is a type of site routinely subjected to FDA inspection, be submitted as a prior approval supplement if the site does not have a satisfactory CGMP inspection within the last two years for the type of operation being moved.
A change from one drug substance manufacturer to another typically involves more than simply a site change. In the majority of cases, there will be additional differences (e.g., route of synthesis, process, solvents, equipment). Without extensive knowledge of both sources (i.e., old and new), an applicant cannot adequately describe the differences between the sources, or evaluate the multiple change. Therefore, in the case where the applicant does not have the extensive knowledge to provide this information and evaluation, the site change should be reported in a prior approval supplement. When an applicant does have the extensive knowledge to describe the differences between the sources, it can report the change as appropriate after evaluation as a multiple change.
I recommend reporting it prior approval unless discussed with your division in advance.
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Darlene O'Banion
San Jose CA
USA
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Original Message:
Sent: 10-13-2011 14:23
From: Kunal Gunjal
Subject: CBE-30
Can you do CBE-30 for change in API vendor for already approved finished product, used for humans.(Our finished product is sterile API filled aseptically into vials with no additives added).
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Kunal Gunjal
Pomona CA
United States
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