FDA发布非青霉素类β-内酰胺药物交叉污染防控CGMP框架指南草案

GUIDANCE DOCUMENT

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination Draft Guidance for Industry June 2022

Draft Level 1 Revised Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2011-D-0104

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance describes methods, facility design elements, and controls that are important in preventing drugs  from being cross-contaminated with compounds containing a beta-lactam ring.   This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of non-penicillin beta-lactam antibacterial drugs and non-antibacterial beta-lactam compounds.   

This guidance recommends complete and comprehensive separation  of the manufacturing operations of non-penicillin beta-lactam antibacterial drugs from the manufacturing operations of other drugs.  For manufacturers of non-antibacterial beta-lactam compounds, this guidance provides recommendations on cross-contamination prevention strategies, including examples of relevant design features and control approaches for those seeking to justify a cross-contamination prevention strategy other than complete and comprehensive separation when appropriate.

Submit Comments

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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