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: a plan for total quality control from manufacturer to consumer
  name:
    name part: Willig, Sidney H.
    name part: 1919-
    role:
      role term: creator
  type of resource: text
  genre: bibliography
  origin info:
    place:
      place term: nyu
    date issued: 2001
    edition: Fifth edition, revised and expanded.
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: print
    extent: xii, 732 pages : illustrations ; 24 cm.
  table of contents: Status and applicability of U.S. regulations: current good manufacturing practices in manufacturing, processing, packaging, and holdings 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 controls (subpart G) -- Holding and distribution (subpart H) -- Laboratory controls (subpart I) -- Records and reports (subpart J) -- Returned and salvaged drug products (subpart K) -- Repacking and relabeling -- Bulk pharmaceutical chemicals -- The pharmacist and total quality control -- Recalls and CGMPs: enforcement alternatives in the United States -- Controlled substances safeguards (21 CFR 1300, et seq.) -- The inspection procedure 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 SUPAC to the Food and Drug Modernization Act -- Who is the manufacturer? Some additional considerations for the multinational -- Other GMPs -- Other approaches to quality -- Import and export of pharmaceuticals and other products subject to CGMPs -- Enhancement of global product distribution -- Appendix A. Food and Drug Modernization Act of 1997 - in pertinent part -- Appendix B. Components/repackagers -- Appendix C. Hearing procedures when FDA proposes the imposition of civil money penalties -- Appendix D. Section 601.12 changes currently considered "important" by CBER -- Appendix E. USP24-NF19 information; monographs; tests; assays.
  note: Sidney H. Willig.
  note: Previous edition is subtitled: A plan for total quality control.
  note: Includes bibliographical references and index.
  subject:
    geographic code: n-us---
  subject:
    topic: Pharmaceutical Preparations
    topic: standards
  subject:
    topic: Drug Industry
    topic: standards
  subject:
    topic: Technology, Pharmaceutical
    topic: standards
  subject:
    topic: Quality Control
  subject:
    topic: Legislation, Drug
  subject:
    geographic: United States
  classification: RS189 .W57 2000
  classification: 615/.19/0685
  classification: QV 771 W732g 2001
  related item:
    title info:
      title: Drugs and the pharmaceutical sciences ; v. 109
  identifier: 0824704258 (alk. paper)
  identifier: 00060188
  record info:
    record content source: DLC
    record creation date: 000724
    record change date: 20210818135251.0
    record identifier: in00004491478