Issue Date: April 17, 2013
Issued by: Center for Drug Evaluation and Research
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Guidance for Industry
This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing betalactams (including both penicillins and non-penicillin beta-lactams). Finally, this guidance clarifies that manufacturers generally should utilize separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with crossreactivity.
Download the Guidance Document
