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: Good manufacturing practices for pharmaceuticals
    sub title: edited by Joseph D. Nally
  name:
    name part: Nally, Joseph D.
  type of resource: text
  genre: bibliography
  origin info:
    place:
      place term: nyu
    date issued: 2007
    edition: Sixth edition.
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: print
    extent: viii, 398 pages : illustrations ; 26 cm.
  table of contents: Status and applicability of U.S. regulations : current good manufacturing practices in manufacturing, processing, packaging, and holding of drugs -- Finished pharmaceuticals : general provisions, Subpart A -- Organization and personnel, Subpart B -- Buildings and facilities, Subpart C -- Equipment, Subpart D -- Control of components and drug product containers and closures , Subpart E -- Production and process controls, Subpart F -- Packaging and labeling control, Subpart G -- Holding distribution, Subpart H -- Laboratory controls, Subpart I -- Records and reports, Subpart J -- Returned and salvaged drug products, Subpart K -- Repacking and relabeling --
  table of contents: Quality systems and risk management approaches -- Clinical trial supplies and current good manufacturing -- Contracting and outsourcing -- Active pharmaceutical ingredients -- Bulk pharmaceutical excipient GMPs -- Recalls, warning letters, seizures and injunctions : CGMP enforcement alternatives in the United States -- Control substances safeguards (21 CFR 1300, et seq.) -- The inspection procedures for compliance in the United States : the regulatee is Inspected; the rationale for Inspection (21 USC 373, 374) -- FDA pre-approval inspections/investigations : The Road from scale-up and post-approval changes in the Food and Drug Modernization Act -- World-wide good manufacturings practices -- Quality approaches : ISO 9000, Malcolm Baldrige, and six sigma -- Appendix A. Center for Drug Evaluation and Research : list of guidance documents -- Appendix B. ICH guidelines -- Appendix C. Food and Drug Administration (FDA)/Office Regulatory Affairs (ORA) compliance policy guides
  note: Revised edition of: Good manufacturing practices for pharmaceuticals / Sidney H. Willig. 5th edition, rev. and expanded.
  note: Includes bibliographical references and index.
  subject:
    topic: Pharmaceutical Preparations
    topic: standards
  subject:
    topic: Drug Industry
    topic: standards
  subject:
    topic: Legislation, Drug
  subject:
    topic: Quality Control
  subject:
    topic: Technology, Pharmaceutical
    topic: standards
  subject:
    geographic: United States
  subject:
    topic: Pharmaceutical industry
    topic: Quality control
  subject:
    topic: Drugs
    topic: Standards
    geographic: United States
  classification: RS189 .W57 2007
  classification: 338.4/76151
  classification: W1 DR893B v.169 2007
  classification: QV 771 G64653 2007
  classification: QV 771 G6467 2007
  related item:
    title info:
      title: Good manufacturing practices for pharmaceuticals
    name:
      name part: Willig, Sidney H.,
      name part: 1919-
  related item:
    title info:
      title: Drugs and the pharmaceutical sciences. v. 169
  identifier: 9780849339721 (hardcover : alk. paper)
  identifier: 0849339723 (hardcover : alk. paper)
  identifier: 2007272501
  record info:
    record content source: NLM
    record creation date: 070115
    record change date: 20191203131804.0
    record identifier: in00004505283