No You Cannot Manufacture Pesticides and Drugs with the Same Machine.
​​​[Posted on: Friday, May 18, 2018]

A Florida facility was found to manufacture pesticides and human pharmaceuticals using the same equipment leading to contamination of the drugs with pesticides as found by FDA auditors during a GMP inspection. The cardinal rule for GMP is “do no harm”, and the first place you control is contamination with unwanted ingredients. So it is hard to imagine the justification for using the same machines for making two very diverse products where one is potentially poisonous. Mixed use equipment is common at most manufacturing facilities. All contract manufacturing organizations use the same facilities and equipment to serve different clients. So the same equipment may be used to manufacture different products, at different times. Between uses, the equipment needs to be cleaned using a method validated to completely remove the previously manufactured product. So, the practice found by FDA auditors in the Florida facility is not uncommon. But there are several measures that need to be taken to avoid intermixing of different products. This includes cleaning validation between cycles, segregation of the manufacturing cycles in time and space. The facility should practice physical and virtual separation of dedicated and common equipment, space and personnel, between diverse products. Some products are simply not compatible to be manufactured on shared equipment. For example, one would not dream of manufacturing yeast products in a facility used for mammalian cells. Such products should never be manufactured on shared equipment. Keeping this in mind, the FDA audit findings at this facility are especially egregious. Manufacturing pesticides and pharmaceutical products on the same equipment should never have happened. The facility was also found to not have a validated cleaning method for the equipment. And the result was pesticide contamination in various lots of the drugs manufactured. It is very possible that drugs contaminated the pesticides as well causing environmental exposure. We would never know the full extent of the damage caused. It is not possible to quantify how often incompatible products are co-manufactured similar to the Florida facility as there is no public data for that but one would hope it is rare.