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Good manufacturing practices for pharmaceuticals : a plan for total quality control / Sidney H. Willig, James R. Stoker.

By: Contributor(s): Material type: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 78Publisher: New York : Marcel Dekker, [1997]Copyright date: ©1997. Edition: Fourth edition, revised and expandedDescription: x, 496 pages : illustrations ; 24 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 0824797701 (acidfree paper)
Subject(s): DDC classification:
  • 20 615.190685 W.S.G
LOC classification:
  • RS189 .W57 1997
NLM classification:
  • W1 DR893B v.78 1997 | QV 771 W732g 1997
Contents:
Status and applicability of U.S. regulations; finished pharmaceuticals; general provisions; organization and personnel; buildings and facilities; equipment; control of components and drug product containers and closures; production and process controls; packaging and labelling control; holding and distribution; laboratory controls; records and reports; returned and salvaged drug products; repackaging and relabelling; the inspection procedure for compliance in the United States; recalls and CGMPs: enforcement alternatives in the United States; controlled substances safeguards; who is the manufacturer? some additional considerations for the multinational; bulk pharmaceutical chemicals; FDA pre-approved inspections/investigations; other GMPs; other approaches to quality; import and export of pharmaceuticals and other products subject to CGMPs. Appendices: potable water requirements; components/repackagers.
Summary: Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.
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Holdings
Item type Current library Collection Call number Copy number Status Date due Barcode
Books Books Main library A11 Pharmacy ( Clinical Pharmacy ) 615.190685 W.S.G (Browse shelf(Opens below)) 1 Available 00016162

Includes bibliographical references and index.

Status and applicability of U.S. regulations; finished pharmaceuticals; general provisions; organization and personnel; buildings and facilities; equipment; control of components and drug product containers and closures; production and process controls; packaging and labelling control; holding and distribution; laboratory controls; records and reports; returned and salvaged drug products; repackaging and relabelling; the inspection procedure for compliance in the United States; recalls and CGMPs: enforcement alternatives in the United States; controlled substances safeguards; who is the manufacturer? some additional considerations for the multinational; bulk pharmaceutical chemicals; FDA pre-approved inspections/investigations; other GMPs; other approaches to quality; import and export of pharmaceuticals and other products subject to CGMPs. Appendices: potable water requirements; components/repackagers.

Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.

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