Non-Pharmaceuticals and Pharmaceuticals on the same Equipment

Questions often arise about using pharmaceutical equipment for both drug and non-drug production. The FDA has recently reinforced its stance on this issue in a new Warning Letter.

 Referring to 21 CFR 211.67(b), which mandates written cleaning and maintenance procedures, the FDA addressed Seatex, LLC, USA, a manufacturer of over-the-counter (OTC) hand sanitizers. The Warning Letter highlighted that the same equipment used for hand sanitizers was also used for industrial chemicals, such as floor cleaners. The FDA made it clear that combining pharmaceutical and non-pharmaceutical production on the same equipment is not acceptable under CGMP standards.

This Warning Letter reaffirms the FDA’s longstanding position against using equipment for both drug and non-drug manufacturing due to GMP concerns. The full Warning Letter is available on the FDA website.