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GUIDANCE DOCUMENT

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination Guidance for Industry April 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0104
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0104.

 
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