http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Good manufacturing practices for pharmaceuticals
viii, 398 pages : illustrations ; 26 cm.
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 --
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
Revised edition of: Good manufacturing practices for pharmaceuticals / Sidney H. Willig. 5th edition, rev. and expanded.
Includes bibliographical references and index.
Drugs and the pharmaceutical sciences. v. 169