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          Current Good Manufacturing Practice for Phase 1 Investigational DrugsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Current Good Manufacturing Practice for Phase 1 Investigational Drugs
					Guidance for Industry
		
		July 2008


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2005-D-0157
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of Regulatory Affairs
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials. These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. This guidance applies, as part of CGMP, quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.


 
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						All written comments should be identified with this document's docket number: FDA-2005-D-0157.

                                                                                  Content current as of:
      08/24/2018
         
                  
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