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Title Guidance for industry [electronic resource] : sterile drug products produced by aseptic processing, current good manufacturing practice.

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:ST 3    ---  Available
Description 1 online resource (59 p.)
Note "Center for Biologics Evaluation and Research (CBER)."
"Office of Regulatory Affairs (ORA)."
"Pharmaceutical CGMPs."
"September 2004."
Bibliography Includes bibliographical references (p. 54-55).
Subject Drugs -- Sterilization -- United States.
Asepsis and antisepsis.
Added Author Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
United States. Food and Drug Administration. Office of Regulatory Affairs.
Added Title Sterile drug products produced by aseptic processing, current good manufacturing practice
Gpo Item No. 0499-T (online)
Sudoc No. HE 20.4702:ST 3

 
    
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