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          Analytical Procedures and Methods Validation for Drugs and BiologicsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Analytical Procedures and Methods Validation for Drugs and Biologics
					
		
		July 2015


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2015-N-0007
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


This guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and the 1987 Guidelines for Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.


 
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						All written comments should be identified with this document's docket number: FDA-2015-N-0007.

                                                                                  Content current as of:
      04/21/2020
         
                  
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