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          Non-Penicillin Beta-Lactam Drugs:  A CGMP Framework for Preventing Cross-ContaminationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Non-Penicillin Beta-Lactam Drugs:  A CGMP Framework for Preventing Cross-Contamination
		 
			Draft Guidance for Industry
		
		June 2022


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Revised Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket 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.


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

                                                                                  Content current as of:
      06/23/2022
         
                  
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