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A relative of mine used to work on automation for a large pharmaceutical manufacturer in the US. He used to talk about how unrelenting the FDA was in their insp
by patwolf 7y ago
A relative of mine used to work on automation for a large pharmaceutical manufacturer in the US. He used to talk about how unrelenting the FDA was in their inspections. The better your processes were, the harder the FDA would try to find new and seemingly arbitrary faults, almost to the point that it would be better to have some glaring but easily fixable issue to distract from all the minor things they would find.
One example he said was that the FDA decided that they couldn't share tools (hammers, wrenches, etc) across manufacturing lines used for different drugs. This was supposedly to prevent cross contamination of the drugs. Generics made in India and China don't have to compete with such high standards.
- xkcd-sucks 7y agoI once attended a talk by a Formulations guy at I think Vertex. They had an incident where one of their production facilities made the wrong crystalline isoform and nobody could figure out why. It eventually ended up being related to the interior paint of the facility.
- credit_guy 7y ago> share tools (hammers, wrenches, etc) across manufacturing lines used for different drugs I never would’ve guessed that they use hammers and wrenches to manufacture drugs.
- Anthony-G 7y agoMy reading of the above is that the hammers and wrenches are used indirectly, i.e., to maintain the equipment on the lines.