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          Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revisionSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision
					Guidance for Industry
		
		May 2022


	Download the  Final Guidance Document 

    Final
		
		    		Level 2 Revised Guidance

	  
	  
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    PrintDocket Number:
		    FDA-1998-D-0019
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance for industry provides the Agency’s current thinking on how to evaluate out-of- specification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.


 
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						All written comments should be identified with this document's docket number: FDA-1998-D-0019.

                                                                                  Content current as of:
      05/16/2022
         
                  
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