title: Microbial Risk in Pharmaceutical Manufacturing and ICH Q9.
authors.affiliation: Food and Drug AdministrationNortheast Regional Laboratory.
authors.forename: Dennis E
authors.initials: DE
authors.lastname: Guilfoyle
authors.forename: Richard L
authors.initials: RL
authors.lastname: Friedman
authors.forename: Patricia F
authors.initials: PF
authors.lastname: Hughes
authors.forename: David
authors.initials: D
authors.lastname: Hussong
authors.forename: Amy S
authors.initials: AS
authors.lastname: Rosenberg
authors.forename: Kurt
authors.initials: K
authors.lastname: Brorson
mesh_terms: D002626:Chemistry, Pharmaceutical; D004345:Drug Industry; D006801:Humans; D012306:Risk; D014486:United States Food and Drug Administration