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Old 03-20-2020, 09:57 AM
OldOlds is offline
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Join Date: Nov 2003
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I'm not in tablets, I'm in injectables (parenterals, in industry jargon)

The good news is that tablet manufacturing is much simpler, with far fewer controls needed. I don't know where CP tablets are made. If there's an FDA-approved facility making them now, that could be ramped up quickly. You'd be amazed at how fast tablet facilities can crank out pills.

In normal times, I'd assume about 12-18 months to convert an existing line to a new product and complete all the validations and inspections. A solid 6+ months of that is the FDA, which could presumably park a team at the plant and cut that Waaaay down in an emergency. With all hands, maybe the changeover could be cut in half. Perhaps some time could be saved by skipping things like stability testing (the calendar is the calendar, so a six month stability takes six months; but for a well established medicine we might decide that isn't needed in an emergency).

So my back of the envelope would be 4-6 months with a Manhattan Project effort.

That assumes the CP itself (known as the Active Pharmaceutical Ingredient, API) is readily available. APIs are typically made at a very different facility than the tablets. If API production needs to be ramped up that could be the real bottleneck. Since I don't know how CP is synthesized I can't say what's involved there. But proper production and safety of the API will be the most critical element of a tablet (I mean, something wrong with the binders isn't likely to kill anyone), so any shortcuts there would have to be taken very carefully.

As for grades and whether (say) using a reference grade, or an industrial grade is safe, well... I wouldn't take my chances. Things produced for human use are done under a very strict set of rules and oversight. Just because someone gives you a CoA for something made under "industrial" rules wouldn't be enough for me. And tiny changes or impurities can be devastating.