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          PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality AssuranceSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
					Guidance for Industry
		
		October 2004


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2003-D-0032
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Center for Drug Evaluation and Research


This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.


 
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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2003-D-0032.

                                                                                  Content current as of:
      08/24/2018
         
                  
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