title: An industry commentary on regulatory issues--microbiology.
authors.affiliation: Vectech Pharmaceutical Consultants, Inc., 24543 Indoplex Circle, Farmington Hills, MI 48335, USA. jmoldenhauer@vectech.com
authors.forename: Jeanne E
authors.initials: JE
authors.lastname: Moldenhauer
mesh_terms: D017408:Guidelines as Topic; D008828:Microbiological Techniques / Q000379:methods / Q000592:standards; D008829:Microbiology / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D012957:Societies, Pharmaceutical; D013678:Technology, Pharmaceutical / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards