> Context: Workers at the plant, which had been producing Johnson & Johnson and AstraZeneca vaccines, conflated the ingredients between the two different types of vaccines, destroying 15 million doses of Johnson & Johnson vaccine, according to the Times.
Errors like this happen in every single GMP and clinical facility.
What makes them different is 1) there are ample checks in place to prevent mistakes from ever leaving the facility, and 2) there is process that reduces the chances of having it happen in the first place.
But all of these places will have incident logs of mistakes like this, along with corrective actions that change the procedures and make it less likely to happen a second time.
> 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.
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!
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.
> 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.
I think you mean it shouldn't happen undetected... these kinds of mistakes can and do happen. Everything from human error (oops, Billy put baking powder in the baking soda tank) to equipment error (the tank valve stuck open, adding 10X more of ingredient X than expected)
Hard to do without knowing anything about this facility, but maybe just not store the ingredients for two different vaccines in the same place. Basically restrict the set of ingredients available to the person making the batch.
Or have the employee log what he is doing in real time BEFORE he does it. I am adding sugar, I am adding eggs, I am adding wheat flour. Then an alert is triggered when the system (which knows what product is being made) recognises that the ingredient doesn't belong.
This is a multi-billion dollar company... they could have the process live-streamed to 30 independent chemists each one watching the "chef's" every move (this is not a serious proposal).
This stuff is all hashed out when one writes up a HACCP process.
