Sounds like what epistasis is describing is a healthy QA environment with rapid feedback. Some other comments have already pointed out that 15M doses is probab

Sounds like what epistasis is describing is a healthy QA environment with rapid feedback. Some other comments have already pointed out that 15M doses is probably only one or a few batches. Combined with the fact that the procedure documents for this particular line are probably still warm from the laser printer, I'd say let them iterate a bit more to get the kinks out. [ Procedures are not (should not be) engraved on stone tablets handed down from on high. If you try it that way, you are just as guaranteed to fail as when you had no procedures at all. ] As to what went wrong at this facility (besides overpromising?); we'll have to see. I wish there was such a thing as open source procedures!