title: Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.
abstract: This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.
authors.forename: Gretchen
authors.initials: G
authors.lastname: Allison
authors.forename: Yanxi Tan
authors.initials: YT
authors.lastname: Cain
authors.forename: Charles
authors.initials: C
authors.lastname: Cooney
authors.forename: Tom
authors.initials: T
authors.lastname: Garcia
authors.forename: Tara Gooen
authors.initials: TG
authors.lastname: Bizjak
authors.forename: Oyvind
authors.initials: O
authors.lastname: Holte
authors.forename: Nirdosh
authors.initials: N
authors.lastname: Jagota
authors.forename: Bekki
authors.initials: B
authors.lastname: Komas
authors.forename: Evdokia
authors.initials: E
authors.lastname: Korakianiti
authors.forename: Dora
authors.initials: D
authors.lastname: Kourti
authors.forename: Rapti
authors.initials: R
authors.lastname: Madurawe
authors.forename: Elaine
authors.initials: E
authors.lastname: Morefield
authors.forename: Frank
authors.initials: F
authors.lastname: Montgomery
authors.forename: Moheb
authors.initials: M
authors.lastname: Nasr
authors.forename: William
authors.initials: W
authors.lastname: Randolph
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Robert
authors.forename: Dave
authors.initials: D
authors.lastname: Rudd
authors.forename: Diane
authors.initials: D
authors.lastname: Zezza
mesh_terms: D003257:Consumer Product Safety; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control; D004345:Drug Industry / Q000295:instrumentation / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards / Q000639:trends; D004866:Equipment Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control; D004868:Equipment Failure; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis* / Q000592:standards; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration; D057188:Workflow
chemical_list: D004364:Pharmaceutical Preparations