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          Microbiological Quality Considerations in Non-Sterile Drug ManufacturingSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
		 
			Draft Guidance for Industry
		
		September 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	Download the  Draft  Guidance Document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	  	    Not for implementation.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-0432
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance is intended to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs). The recommendations herein apply to solid non-sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions). NSDs can be prescription or nonprescription drugs, including those marketed under approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), and nonprescription drugs without approved new drug applications which are governed by the provisions of section 505G of the FD&C Act (often referred to as over-the-counter (OTC) monograph drugs). These recommendations, if followed, will also assist manufacturers in complying with the current good manufacturing practice (CGMP) requirements for finished pharmaceuticals and active pharmaceutical ingredients (APIs).


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-0432.

                                                                                  Content current as of:
      09/28/2021
         
                  
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