Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
					
		
		January 2024


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  	    This guidance is being distributed for comment purposes only.
	  
	Share
    Post
    Linkedin

    Email
    Print**Submit Comments by** 03/25/2024
	  	Submit Comments Online
			Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. 
				If unable to submit comments online, please mail written comments to:
				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-2023-D-4761
	Docket Number:
		    FDA-2023-D-4761
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine


This document provides guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.  It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.




  
	Questions?
	
  Contact Point
          Mai Huynh
				    		    	
		    		    	Center for Veterinary Medicine
Office of New Animal Drug Evaluation
Food and Drug Administration
7500 Standish Place, HFV-142
Rockville, MD 20855
		Mai.Huynh@fda.hhs.gov
		    
		    		    	240-402-0669

                                                                                  Content current as of:
      01/24/2024
         
                  
Regulated Product(s)
		 Animal & Veterinary
			  			     			  						              
						  Generic Animal DrugsTopic(s)
			  Postmarket
				    				       				    				       Premarket
				       				    				       Compliance
				       				    					
				          
				  Investigational New Animal Drug (INAD)
				  				     				  				     New Animal Drug Application (NADA)
				     				  				     VICH
				     				  				  
				  
				  
				  
				   
				  
				  				  Current Good Manufacturing Practice (CGMP)
				  				     				  				     Chemistry, Manufacturing, and Controls (CMC)Search for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop