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          ANDAs: Impurities in Drug ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	ANDAs: Impurities in Drug Products
					Guidance for Industry
		
		November 2010


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2010-D-0584
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting.


 
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						All written comments should be identified with this document's docket number: FDA-2010-D-0584.

                                                                                  Content current as of:
      04/22/2020
         
                  
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