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          PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory SitesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites
					Guidance for Industry
		
		April 1998


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-1998-D-1157
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance provides recommendations to pharmaceutical sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) who intend to change an analytical testing laboratory site for components, drug product containers, closures, packaging materials, inprocess materials, or drug products during the postapproval period. Analytical testing laboratories include those performing physical, chemical, biological, and microbiological testing to monitor, accept, or reject materials as well as those performing stability testing.


 
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						All written comments should be identified with this document's docket number: FDA-1998-D-1157.

                                                                                  Content current as of:
      08/24/2018
         
                  
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