FDA issues guidance on preventing antibiotic cross-contamination
pharmafile | April 19, 2011 | News story | Manufacturing and Production |Â Â FDA, GMP, pharma manufacturingÂ
The FDA has published a new guidance document to help drugmakers prevent cross-contamination of pharmaceuticals with non-penicillin beta-lactam antibiotics.
The US regulator has already adopted guidelines to prevent cross-contamination with penicillin antibiotics, which can cause serious and potentially life-threatening allergic reactions in some people, and now wants to extend that to include non-penicillin antibiotics in the beta lactam class, including cephalosporins, penems, carbacephems and monobactams.
At the moment, all manufacturers of penicillins, including repackers, are required by Good Manufacturing Practice regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs. Until now there has been no official guidance however on non-penicillin beta lactams.
“The potential health hazard of non-penicillin beta-lactam drugs is … similar to that of penicillins,” says the guidance, which is available to view here.
“Cross-reactivity (cross-sensitivity) between beta lactam products has been and continues to be a major concern in the manufacture of drugs,” it goes on.
The document covers the manufacture of both finished pharmaceuticals and active pharmaceutical ingredients (APIs), and lays out various GMP principles for operators of plants which make non-penicillin beta-lactam antibiotics as well as other product lines.
The guidance recommends that manufacturers assess and establish strict facility and equipment controls to prevent cross-contamination of beta lactam compounds, including intermediates and by-products involved in their production, with non-penicillin beta-lactam drugs.
“The section of a facility dedicated to manufacturing a sensitizing non-penicillin beta-lactam should be structurally isolated … from areas in the facility in which other products are manufactured,” says the guidance, which notes this can include air-handling systems.
In addition to the patient safety elements, cross-contamination concerns can cause major disruption to commercial operations.
In one case, the FDA withheld approval of a sensitising beta-lactam manufacturing facility that was adjacent to another drug processing building, due to the lack of containment controls.
Phil Taylor
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