For an immediate release oral tablet that used the same bulk granulation to compress 3 different strengths of tablets, we were successful in getting FDA approval for putting one lot up on stability each year (not one lot of each strength) and then rotate the strength from year to year so a batch of each strength was put up on stability every 3 years. We included this in our initial NDA and was accepted by FDA. Being a biologic, this may involve other considerations that others on this forum may comment on. Prior Approval Supplement with justification.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 11-Apr-2024 13:39
From: Anonymous Member
Subject: Reducing # of post approval annual stability batches required (US BLA drug product)
This message was posted by a user wishing to remain anonymous
We currently manufacture one bulk batch of drug product a year and fill it into 3 dose presentations. Some years we only fill 2 lots of each dose. Our P.8.2 stability commitment is to place at least one lot of each dosage in the post approval stability program. So most years we place at least 50% of the lots we produce on stability.
I understand the industry standard to place one at least one batch of each dose manufactured each year on stability comes from the PIC/S Guide to Good Manufacturing Practice for Medicinal Products Part I.
Has anyone successfully reduced the number of batches required for the post approval stability program? If so, what was your rationale? Do you think in our case FDA might agree to only putting one lot of the lowest and one lot of the highest dose on stability? What about only 1 dose lot, if all lots made that year come from the same bulk batch of drug product?
I look forward to your insightful responses!