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          Formal Dispute Resolution:  Scientific and Technical Issues Related to Pharmaceutical CGMPSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Formal Dispute Resolution:  Scientific and Technical Issues Related to Pharmaceutical CGMP
					
		
		January 2006


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2003-D-0369
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.” The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers.


 
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						All written comments should be identified with this document's docket number: FDA-2003-D-0369.

                                                                                  Content current as of:
      08/24/2023
         
                  
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