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Title Guidance for industry [electronic resource] : 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.

Imprint

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]

Connect to
Connect to https://permanent.fdlp.gov/lps112518/ucm073423.pdf

Copies

Location	Call No.	OPAC Message	Status
Axe Federal Documents Online	HE 20.4702:P 49/ANNEX 4 C	---	Available

Description	i, 3 p. : digital, PDF file
System Details	Mode of access via the CDER web site.
Note	Title from title screen (viewed on May 12, 2009).
	"April 2009."
Bibliography	Includes bibliographical references (p. 3).
Subject	Pharmacopoeias -- Standards -- International cooperation.
	Drugs -- Microbiology -- Standards -- International cooperation.
Added Author	Center for Drug Evaluation and Research (U.S.)
	Center for Biologics Evaluation and Research (U.S.)
Added Title	Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region
	Microbiological examination of nonsterile products
Gpo Item No.	0499-T (online)
Sudoc No.	HE 20.4702:P 49/ANNEX 4 C