Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4C, Microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter.

Bibliographic Details
Corporate Authors:	Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009]
Subjects:	Pharmacopoeias > Standards > International cooperation. Drugs > Microbiology > Standards > International cooperation.
Online Access:	https://purl.fdlp.gov/GPO/LPS112518

Description
Item Description:	Title from title screen (viewed on May 12, 2009). "April 2009." Electronic resource.
Physical Description:	i, 3 pages : digital, PDF file.
Format:	Mode of access: Internet from the CDER web site. Address as of 5/12/09: http://www.fda.gov/cder/guidance/8671fnl.pdf ; current access available via PURL.
Bibliography:	Includes bibliographical references (page 3).