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Title Guidance for industry [electronic resource] : process validation, general principles and practices.

Imprint Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:P 49/6    ---  Available
Description [20] p. : digital, PDF file
System Details Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf ; current access is available via PURL.
Note Title from PDF title page (viewed on Mar. 24, 2009).
"Draft guidance."
"November 2008."
Bibliography Includes bibliographical references (p. [20]).
Subject Biologicals -- Evaluation.
Drugs -- Testing.
Manufacturing processes -- Evaluation.
Added Author Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Center for Veterinary Medicine (U.S.)
Added Title Process validation, general principles and practices
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:P 49/6

 
    
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