title: Quality control analytical methods: strategies to ensure a robust quality-control microbiology program.
abstract: As the regulatory environment for compounding pharmacies continues to evolve, facilities can take immediate steps to strengthen their quality-control microbiology and environmental monitoring programs. Robust programs that are timely, comprehensive, and effective will minimize risk and help support positive patient outcomes. This article provides a roadmap for putting in place a robust quality-control microbiology program in the face of United States Pharmacopeia Chapter 797 standards, and highlights several technologies for environmental monitoring that support a successful program.
authors.affiliation: EMD Millipore Corporation, Billerica, Massachusetts 01821, USA. tricia.griffiths@emdmillipore.com
authors.forename: Tricia
authors.initials: T
authors.lastname: Griffiths
authors.forename: Anne
authors.initials: A
authors.lastname: Connors
mesh_terms: D004339:Drug Compounding / Q000379:methods / Q000592:standards*; D004783:Environmental Microbiology / Q000592:standards; D004784:Environmental Monitoring / Q000379:methods; D004866:Equipment Contamination / Q000517:prevention & control*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations