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> Errors like this happen in every single GMP and clinical facility. They shouldn't happen in a 150yr old, multi-billion dollar pharmaceutical company. How ha

> Errors like this happen in every single GMP and clinical facility. They shouldn't happen in a 150yr old, multi-billion dollar pharmaceutical company. How hard is it to restrict the ingredients available to the "chef" to the ones needed for the current product? Not hard at all unless you want to save a few dollars cutting corners.

Kim_Bruning 6y ago
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!
epistasis 6y ago
Being GMP isn't about eliminating all errors everywhere, it's about acknowledging the inevitability of error, minimizing error through conscious processes that stop those errors, and testing to assure that you made what you made. In a situation where maximizing vaccine production sooner saves lives, pinning this on saving a few dollars doesn't make sense. Whatever they were doing cost them quite a few dollars in addition to the lives lost from slower vaccination. I don't know their process, but suppose the "restricting the ingredients" phase happens. What if the ingredients were swapped at the time of restriction? Same problem happens.
- markdown 6y ago
  > What if the ingredients were swapped at the time of restriction? Same problem happens. Chef goes to find eggs as required by the recipe for his cake, and finds that there are none. Instead there is pepper, an ingredient not required by the recipe.

Kim_Bruning 6y ago

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!

epistasis 6y ago

Being GMP isn't about eliminating all errors everywhere, it's about acknowledging the inevitability of error, minimizing error through conscious processes that stop those errors, and testing to assure that you made what you made. In a situation where maximizing vaccine production sooner saves lives, pinning this on saving a few dollars doesn't make sense. Whatever they were doing cost them quite a few dollars in addition to the lives lost from slower vaccination. I don't know their process, but suppose the "restricting the ingredients" phase happens. What if the ingredients were swapped at the time of restriction? Same problem happens.

markdown 6y ago
> What if the ingredients were swapped at the time of restriction? Same problem happens. Chef goes to find eggs as required by the recipe for his cake, and finds that there are none. Instead there is pepper, an ingredient not required by the recipe.