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Hi Tom, What you describe is quite typical to change manufacturers to meet market needs after NDA approval. Clearly the NDA has been submitted with the initial micronizer. If (when) the NDA is approved, the approval will be based on the initial micronizer. In order to introduce the 2nd micronizer, ...

I did not think the question was about biologics or a BLA. Floor plans could be needed for an aseptically produced biologic. ------------------------------ Peter Smith Principal Smith GMP Consulting Narragansett, Rhode Island USA ------------------------------

There is no need to provide such details as floor plans in an NDA (unless requested, but that is extremely unlikely). Floor plans are of interest to and Investigator conducting an inspection, but likely of no use to a reviewer. ------------------------------ Peter Smith Principal Smith GMP Consulting ...

Regarding your post about a DMF being referenced in an IND triggering an FDA inspection, generally FDA does not conduct inspections on this basis. However, when I was in FDA occasionally reviewers would request a brief inspection covering an IND (particularly for Phase 3) when the referenced company ...

Hello Sujan. None of the previous replies make reference that reduced testing is clearly described in the drug GMP regulations in 21 CFR 211, Subpart E, 122.80 - Control of Components and Drug Product Containers and Closures, specifically 211.84(d)(2) as follows: "(2) Each component shall be tested ...