Guidance for industry : process validation, general principles and practices.

Guidance for industry : process validation, general principles and practices.

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Bibliographic Details
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]
Description:20 unnumbered pages : digital, PDF file
Language:English
Subject:
Biologicals -- Evaluation.
Drugs -- Testing.
Manufacturing processes -- Evaluation.
Format: E-Resource U.S. Federal Government Document Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/7682462
Hidden Bibliographic Details
Varying Form of Title:Process validation, general principles and practices
Other authors / contributors:Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Center for Veterinary Medicine (U.S.)
Notes:Title from PDF title page (viewed on Mar. 24, 2009).
"Draft guidance."
"November 2008."
Includes bibliographical references (page [20]).
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.
GPO item no.:0499-T-02 (online)
Govt.docs classification:HE 20.4802:P 49/6

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