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          Inspection of Injectable Products for Visible ParticulatesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Inspection of Injectable Products for Visible Particulates
		 
			Draft Guidance for Industry
		
		December 2021


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2021-D-0241
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Center for Veterinary Medicine


Visible particulates in injectable products can jeopardize patient safety. This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The guidance also clarifies that meeting an applicable United States Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products. The guidance does not cover subvisible particulates or physical defects that products are typically inspected for along with inspection for visible particulates (e.g., container integrity flaws, fill volume, appearance of lyophilized cake/suspension solids).


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-0241.

                                                                                  Content current as of:
      12/17/2021
         
                  
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