Non-Penicillin Beta-Lactam Risk Assessment:A CGMP Framework

Please find attachment of the FDA guidance that was released in March 2011

FDA.pdf (115.6 KB)

[b][COLOR=“blue”]Structural isolation is defined in the guidance as “completely and comprehensively separated”. In a clarification of cGMP (current good manufacturing practice) penicillin guidance the FDA said options other than completely separate buildings are viable.

If production occurs in the same building the penicillin area must be structurally isolated and use completely separate air handling systems. Manufacturers must test non-penicillin products for cross-contaminants where the possibility of exposure exists.

The non-penicillin beta lactam draft guidance highlights the similarity with penicillin: “Just as FDA considers the separation of production facilities for penicillins to be cGMP, FDA expects manufacturers to treat sensitising non-penicillin beta lactam-based products similarly.”

Application of these recommendations covers separation of areas manufacturing different classes of non-penicillin beta lactams, as well as sections producing unrelated products, such as aspirin.

In plants producing a specific class of beta lactam compound, such as the cephalosporin family, production campaigning and cleaning could be sufficient. Separate facilities and air handling systems are unlikely to be required in these cases. [/color][/b]