rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Establishing a CGMP laboratory audit system
  title info:
    sub title: a practical guide
  title info: title
  name:
    name part: Bliesner, David M.
    role:
      role term: creator
  type of resource: text
  origin info:
    place:
      place term: xx
    place:
      place term: Hoboken, N.J
    publisher: Wiley-Interscience
    date issued: 2006
    date issued: 9999
    issuance: monographic
  language:
    language term: und
  physical description:
    form: print
  abstract: In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: Improve current compliance; Demonstrate sustainable compliance; Produce data for federal inspections; Avoid regulatory action
  note: David M. Bliesner
  subject:
    topic: Pharmaceutical industry,Drugs,Drug Industry,Ngành công nghiệp dược phẩm
  subject:
    topic: Law and legislation,standards
  subject:
    geographic: United States,United State,United States,Hoa Kỳ
  classification: 343.7307
  classification: B649
  record info:
    record creation date: 210402
    record identifier: CTU_214512