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
    sub title: a practical guide
  name:
    name part: Bliesner, David M.
    role:
      role term: creator
  name:
    name part: John Wiley & Sons
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  origin info:
    place:
      place term: flu
    date issued: 2006
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: electronic
    form: remote
    extent: xv, 277 pages ; cm.
  table of contents: Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- Summary -- Appendixes -- Example audit checklists: laboratory sub elements -- Audit summary report example-template -- Glossary of CGMP and audit system terms -- Food and drug administration compliance program: guidance manual 7356.002 "drug manufacturing inspections" -- 21 Code of Federal Regulations parts 210 and 211: 487 current good manufacturing practice regulations.
  note: David M. Bliesner.
  note: Electronic resource.
  note: Electronic reproduction. Somerset, New Jersey : Wiley InterScience. Available via World Wide Web.
  note: Includes bibliographical references and index.
  subject:
    geographic code: n-us---
  subject:
    topic: Drug Industry
    topic: standards
  subject:
    topic: Laboratories
    topic: standards
  subject:
    topic: Drug Industry
    topic: legislation & jurisprudence
  subject:
    topic: Laboratories
    topic: legislation & jurisprudence
  subject:
    topic: Management Audit
    topic: methods
  subject:
    geographic: United States
  subject:
    topic: Drugs
    topic: Law and legislation
    geographic: United States
  subject:
    topic: Pharmacy
    topic: Law and legislation
    geographic: United States
  subject:
    topic: Current Good Manufacturing Practices.
  classification: KF1879 .B55 2006
  classification: 343.7307/86151
  classification: QV 736 B648c 2006
  related item:
    identifier: (DLC) 2005024178.
  identifier: 0471738409 (cloth : alk. paper)
  identifier: 0471784788 (electronic bk.)
  identifier: 9780471738404 (cloth : alk. paper)
  identifier: 9780471784784 (electronic bk.)
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: DG1
    record creation date: 061003
    record change date: 20210810091126.0
    record identifier: in00002402423