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]