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Zdrowie i gospodarka · 15/03/2011

Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework." This guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non- penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers in assessing whether separate facilities should be used based on the relative health risk of cross-reactivity.

Source: Federal Register — Health and Human ServicesOpen original release →