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          Elemental Impurities in Drug Products Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Elemental Impurities in Drug Products Guidance for Industry
					
		
		August 2018


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2016-D-1692
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


This guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities (ICH Q3D).


 
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						All written comments should be identified with this document's docket number: FDA-2016-D-1692.

                                                                                  Content current as of:
      08/07/2018
         
                  
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