http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Good manufacturing practices for pharmaceuticals
a plan for total quality control from manufacturer to consumer
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.
Previous edition is subtitled: A plan for total quality control.
Includes bibliographical references and index.
Drugs and the pharmaceutical sciences ; v. 109