Make GMP product in non-GMP facility?

Ok here is my crazy question:
I work for a compnay which has an industrial non GMP division and a division which is GMP and makes OTC products. Equipment wise we have similar equipment. One production line we have in the non gmp division is a larger version of the one in the gmp side. There is a consideration at this moment to run GMP product on our larger line since it goes faster and is wider. The question revolves around the fact that the big guys want to keep running both our non gmp products and the gmp products on that same line. Does anyone know of any regulations that would specifically prohibit this practice? My own internal alarms are screaming on this but I can't find a specific regulation to cite.

21CFR 211.67:

"Equipment and utensils shall be cleaned, maintained, and
sanitized at appropriate intervals to prevent malfunctions or
contamination that would alter the safety, identity, strength, quality,
or purity of the drug product beyond the official or other established
requirements."

I'd be worried about cross-contamination - so would the FDA.

Is the product a drug, or a device?

Scott Catron said:

I'd be worried about cross-contamination - so would the FDA.

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I agree with Scott. I think that if you chose to do this you would have to manufacture the non-GMP materials under GMP rules (full change control, line clearance, cleaning etc..) which would have a significant cost impact, as well as a training issue, as the "non-GMP" staff would have to learn how to operate in a GMP enviornment. It smells like trouble ........

jimmy

MIREGMGR said:

Is the product a drug, or a device?

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The gmp product is an transdermal patch. The non-gmp could be any number of adhesives tapes or liners or an excipient to a med device.

Jimmy the Brit said:

I agree with Scott. I think that if you chose to do this you would have to manufacture the non-GMP materials under GMP rules (full change control, line clearance, cleaning etc..) which would have a significant cost impact, as well as a training issue, as the "non-GMP" staff would have to learn how to operate in a GMP enviornment. It smells like trouble ........

jimmy

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All good points that I have in my list of "cons" to outweigh their minimal "pro" list. We have some of those items in place for the non-gmp product lines but they are minimal and not anywhere closer to as rigorous as those required for the GMP product lines.