Pharmaceuticals and Non-Pharmaceuticals on the same Equipment

Questions about the simultaneous use of pharmaceutical equipment for the production of pharmaceuticals and non-pharmaceuticals come up again and again. In the GMP News "Consequences of manufacturing non-pharmaceutical Products on pharmaceutical Equipment" you could also already read about this topic. In a recent Warning Letter, the FDA has now reconfirmed its position. What does it say?

Citing 21 CFR 211.67 (b), which requires written instructions for cleaning and maintaining equipment, the FDA first states that the company manufactures over-the-counter (OTC) drugs. In this case, these are hand sanitizers. Non-pharmaceuticals are also manufactured on the same equipment on which the hand sanitizer is produced. Industrial chemicals, e.g. floor cleaners, are mentioned as an example in the Warning Letter. It clearly states that the production of pharmaceuticals and non-pharmaceuticals on the same equipment is not acceptable in terms of CGMP!

This Warning Letter confirms the FDA's statements from the past when it comes to the simultaneous use of equipment for the manufacture of drugs and non-drugs: it is not permitted for GMP reasons.

You can find the entire Warning Letter on the FDA website.