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          CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical QualitySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
					
		
		July 2023


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2018-D-4417
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance describes a program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality. FDA’s participation in the development and use of technical voluntary consensus standards has been integral to the execution of FDA’s mission. For example, FDA has used such standards to develop and/or evaluate performance characteristics of dosage forms, testing methodologies, manufacturing practices, product standards, scientific protocols, ingredient specifications, labeling of drug products, and other technical or policy criteria.


 
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						All written comments should be identified with this document's docket number: FDA-2018-D-4417.

                                                                                  Content current as of:
      07/26/2023
         
                  
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