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Home » FDA Flags Minor CMC Changes That Only Require Annual Reporting
FDA Flags Minor CMC Changes That Only Require Annual Reporting
August 10, 2017
Biologics sponsors will only need to report minor post-approval manufacturing changes on an annual basis, the FDA said, in a new draft guidance.
The guidance lists examples of chemistry, manufacturing and controls changes to BLAs — including in production, quality controls, equipment, facilities or personnel — that will have minimal effect on the product.
Examples of minimal-impact changes include: reductions in overages from production batches used to compensate for manufacturing losses; changes in the location of production steps within a manufacturing area; and the manufacture of an additional product in a multiple-product area listed in an approved BLA.
Moderate or major changes may require preapproval, the agency said.
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