We are in planning early stage clinicals (Phase 1) with a pharmaceutical product (powder in vial) that has to be sterilized by gamma irradiation. I understand that there are several methods (AAMI) to do the validation.
My question is that for an early stage product, where we are not making many lots, can we do a single lot validation. For example, if we take the VDmax approach, can we do a single lot, do 10 vials for bioburden, 5 for recovery, vials for B&F, and test either 10 or 100 vials for sterility and, provided the data is adequate to satisfy the FDA requirements as to the products sterility for use in a clinical trial. I understand the alternative is to do three lots, but have heard others talk about a single lot validation.
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Robert Blanks
VP Chemistry Manufacture and Control
Flexion Therapeutics
Woburn MA
United States
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